U.S. patent application number 12/426034 was filed with the patent office on 2009-10-22 for lipid-containing compositions and methods of use thereof.
This patent application is currently assigned to ASHA LIPID SCIENCES, INC.. Invention is credited to Urvashi Bhagat.
Application Number | 20090264520 12/426034 |
Document ID | / |
Family ID | 41201653 |
Filed Date | 2009-10-22 |
United States Patent
Application |
20090264520 |
Kind Code |
A1 |
Bhagat; Urvashi |
October 22, 2009 |
LIPID-CONTAINING COMPOSITIONS AND METHODS OF USE THEREOF
Abstract
Lipid compositions comprising nuts, seeds, oils, legumes,
fruits, grains, and dairy useful in specified amounts as dietary
supplements and diet plans designed around and including the
aforementioned for the prophylaxis and treatment of numerous
diseases are disclosed. The compositions include omega-6 and
omega-3 fatty acids where the ratio of the omega-6 to the omega-3
fatty acids and their amounts are controlled based on one or more
factors including age of the subject, sex of the subject, diet of
the subject, the body weight of the subject, medical conditions of
the subject, and climate of the subject's living area.
Inventors: |
Bhagat; Urvashi; (Palo Alto,
CA) |
Correspondence
Address: |
GREENBERG TRAURIG, LLP (SV);IP DOCKETING
2450 COLORADO AVENUE, SUITE 400E
SANTA MONICA
CA
90404
US
|
Assignee: |
ASHA LIPID SCIENCES, INC.
Palo Alto
CA
|
Family ID: |
41201653 |
Appl. No.: |
12/426034 |
Filed: |
April 17, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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61046747 |
Apr 21, 2008 |
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61075708 |
Jun 25, 2008 |
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61111593 |
Nov 5, 2008 |
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Current U.S.
Class: |
514/458 ;
514/560 |
Current CPC
Class: |
A61P 15/00 20180101;
A61P 25/20 20180101; A61K 31/20 20130101; A61K 36/54 20130101; A61K
36/63 20130101; A61K 36/736 20130101; A61P 25/18 20180101; A61P
37/02 20180101; A61P 43/00 20180101; A61P 35/00 20180101; A61P
37/00 20180101; A61K 31/201 20130101; A61K 36/286 20130101; A61P
3/06 20180101; A61P 17/00 20180101; Y02A 90/10 20180101; A61P 11/00
20180101; A61K 36/22 20130101; A61K 36/42 20130101; A61P 3/10
20180101; A61P 3/04 20180101; A61K 31/355 20130101; A61P 25/28
20180101; A23L 33/105 20160801; A61K 36/889 20130101; A61P 21/02
20180101; A61P 27/02 20180101; A61P 31/00 20180101; A61K 36/52
20130101; A61P 39/06 20180101; A61P 15/08 20180101; A23D 9/00
20130101; A23L 33/12 20160801; A61P 5/14 20180101; A61P 13/12
20180101; A61P 37/06 20180101; A23L 25/00 20160801; A61P 21/00
20180101; A61P 9/00 20180101; A61P 19/00 20180101; A61P 5/00
20180101; A61P 1/02 20180101; A61K 31/202 20130101; A61K 36/28
20130101; A61P 1/00 20180101; A23L 33/115 20160801; A61P 29/00
20180101; A61P 39/00 20180101; A23V 2002/00 20130101; A61K 36/48
20130101; A23V 2002/00 20130101; A23V 2200/316 20130101; A23V
2250/1882 20130101; A23V 2002/00 20130101; A23V 2200/326 20130101;
A23V 2200/322 20130101; A23V 2250/1882 20130101; A61K 36/48
20130101; A61K 2300/00 20130101; A61K 36/54 20130101; A61K 2300/00
20130101; A61K 36/63 20130101; A61K 2300/00 20130101; A61K 36/28
20130101; A61K 2300/00 20130101; A61K 36/286 20130101; A61K 2300/00
20130101; A61K 36/736 20130101; A61K 2300/00 20130101; A61K 36/22
20130101; A61K 2300/00 20130101; A61K 36/42 20130101; A61K 2300/00
20130101; A61K 36/52 20130101; A61K 2300/00 20130101; A61K 36/889
20130101; A61K 2300/00 20130101 |
Class at
Publication: |
514/458 ;
514/560 |
International
Class: |
A61K 31/355 20060101
A61K031/355; A61K 31/20 20060101 A61K031/20 |
Claims
1. A lipid-containing composition comprising daily optimal amounts
of fatty acids and phytochemicals for a mammalian subject based on
one or more factors selected from the following group: age of the
subject, sex of the subject, diet of the subject, the body weight
of the subject, medical conditions of the subject, and climate of
the subject's living area.
2. The composition of claim 1, wherein said composition is
administered to the subject by steady delivery.
3. The composition of claim 1, wherein such composition further
comprises omega-6 and omega-3 fatty acids and wherein the ratio of
omega-6 to omega-3 fatty acids and their amounts are controlled
based on one or more factors selected from said group.
4. The composition of claim 3, wherein said ratio of omega-6 to
omega-3 fatty acid is in the range of 4:1 to 45:1.
5. The composition of claim 3, wherein said ratio of omega-6 to
omega-3 fatty acid is in the range of 1:1 to 10:1 and said subject
has a diet of low anti-oxidants and/or low phytochemicals.
6. The composition of claim 3, further comprising one or more
omega-9 fatty acids wherein the ratio of omega-9 to omega-6 fatty
acids is also determined based on one or more factors selected from
said group.
7. The composition of claim 6, wherein said ratio of omega-9 to
omega-6 is in the range of 1:1 to 5:1; said ratio of omega-6 to
omega-3 is in the range of 1:1 to 45:1; and said medical condition
is associated with a form of lipid imbalance.
8. The composition of claim 6, wherein said omega-9 fatty acid is
in the range of 10% to 80% of total lipids in the composition; said
omega-6 fatty acid is in the range of 4% to 60% of total lipids in
the composition; and said omega-3 fatty acid is in the range of
0.3% to 20% of total lipids in the composition.
9. The composition of claim 1, wherein the fatty acid components of
the composition is achieved at least in part by using one or more
of the following concentrated lipid sources: oils, butters, nuts,
and seeds.
10. The composition of claim 1, wherein said group further includes
lipid tolerance of said subject.
11. The composition of claim 1, which is used as a dietary
component.
12. The composition of claim 6, wherein said omega-9 is in the
range of 15% to 80% of total lipids in the composition and wherein
said omega-6 is in the range of 8% to 60% of total lipids in the
composition and omega-3 in the range of 0.3% to 12% of total lipids
in the composition.
13. The composition of claim 12, further comprising: a vitamin E
wherein an amount of the vitamin E is in the range of 0.001% to
0.2% of total lipids in the composition.
14. The composition of claim 6, said subject being an omnivorous
human, or a human with low antioxidant and/or low phytochemical
diet, said omega-9 lipids being in the range of 15% to 80% of total
lipids in the composition, wherein said omega-6 are in the range of
6% to 53% of total lipids in the composition and said omega-3
lipids are in the range of 1% to 18% of total lipids in the
composition.
15. The composition of claim 14, further comprising: a vitamin E in
the range of 0.005% to 0.2% of total lipids in the composition.
16. A lipid-containing composition comprising polyunsaturated,
monounsaturated, and saturated fatty acids, wherein the ratios and
amounts of said three fatty acid types are controlled based on one
or more of the following factors for a mammalian subject: age, sex,
climate, body weight, diet, and medical conditions.
17. The composition of claim 16, wherein additional nutrients are
also controlled based on one or more of said factors and wherein
said additional nutrients are one or more components selected from
the following group: phytochemicals, antioxidants, vitamins, and
minerals.
18. A method of creating a balanced diet plans, using the
composition of claim 16.
19. The method of claim 17, wherein lipid-free or low-lipid foods
are designed for use in combination with said lipid composition to
achieve a balanced diet plan.
20. The composition of claim 16, wherein the ratio of a total fatty
acid content to monounsaturated content in the composition is in
the range of 1.25:1 to 4:1; wherein the ratio of monounsaturated to
polyunsaturated fatty acids in the composition is in the range of
1:1 to 3:1; and wherein the ratio of monounsaturated fatty acids to
saturated fatty acids in the composition is in the range of 1:1 to
5:1.
21. The composition of claim 16, comprising one or more of the
following components: peanut oil, vegetable oil, avocado oil, olive
oil, sunflower oil, safflower oil.
22. The composition of claim 16, further comprising one or more of
the following components: mustard oil, palm oil, and soybean
lecithin.
23. The composition of claim 16, comprising three or more of the
following components: a peanut oil present at 8 to 56 percent by
weight in said composition; a vegetable oil present at 8 to 46
percent by weight in said composition; an avocado oil present at 3
to 16 percent by weight in said composition; an olive oil present
at 5 to 32 percent by weight in said composition; a sunflower oil
present at 6 to 34 percent by weight in said composition; and a
safflower oil present at 2 to 30 percent by weight in said
composition.
24. The composition of claim 16, wherein said controlled fatty acid
components come from one or more of the following nuts and seeds:
peanuts, almonds, olives, soybeans, cashews, pistachios, pumpkin
seeds, sunflower seeds, walnuts, coconut meat.
25. The composition of claim 16, wherein said controlled fatty acid
components further come from anhydrous butter.
26. A lipid-containing composition suitable for administration to a
mammalian subject, the lipid composition comprising three or more
of the following components: peanuts present at 2 to 11 percent by
weight in said composition; almonds present at 5 to 32 percent by
weight in said composition; olives present at 6 to 36 percent by
weight in said composition; soybeans present at 4 to 25 percent by
weight in said composition; cashews present at 4 to 21 percent by
weight in said composition; pistachios present at 2 to 9 percent by
weight in said composition; pumpkin seeds present at 2 to 15
percent by weight in said composition; sunflower seeds present at 1
to 4 percent by weight in said composition; walnuts present at 3 to
25 percent by weight in said composition; anhydrous butter present
at 4 to 24 percent by weight in said composition; and coconut meat
present at 1 to 6 percent by weight in said composition.
27. A lipid-containing composition suitable for administration to a
mammalian subject, the lipid composition comprising three or more
of the following components: an almond oil present at 2 to 23
percent by weight in said composition; an avocado oil present at 1
to 7 percent by weight in said composition; a soybean oil present
at 1 to 7 percent by weight in said composition; a cashew oil
present at 2 to 15 percent by weight in said composition; a
pistachio oil present at 1 to 7 percent by weight in said
composition; a pumpkin seed oil present at 1 to 8 percent by weight
in said composition; a walnut oil present at 3 to 25 percent by
weight in said composition; a peanut oil present at 5 to 30 percent
by weight in said composition; a corn oil present at 3 to 19
percent by weight in said composition; an olive oil present at 3 to
17 percent by weight in said composition; a safflower oil present
at 1 to 14 percent by weight in said composition; and an anhydrous
butter oil present at 5 to 29 percent by weight in said
composition.
28. A method of prophylaxis or treatment of a medical condition for
a mammalian subject, said method comprising administering a
therapeutically effective amount of the composition of claim 16 to
said subject, wherein said medical condition is linked with a lipid
imbalance in said mammalian subject.
29. The method of claim 28, wherein said medical condition is
selected from the group consisting of: a symptom of menopause, a
cardiovascular disease, a mental disorder, a neural disorder, a
musculoskeletal disorder, an endocrine disorder, a cancer, a
digestive system disorder, a symptom of aging, a viral infection, a
bacterial infection, obesity, overweight, a renal disease, a
pulmonary disorder, an ophthalmologic disorder, a dermatological
disorder, a sleep disorder, a dental disease, an immune system
disease, and an autoimmunity.
30. A lipid composition suitable for administration to a mammalian
subject, the lipid composition comprising three or more of the
following components: an almond oil present at 1 to 36 percent by
weight in said composition; a pumpkin seed oil present at 1 to 24
percent by weight in said composition; an oil from walnuts present
at 2 to 36 percent by weight in said composition; a peanut oil
present at 4 to 72 percent by weight in said composition; a corn
oil present at 1 to 24 percent by weight in said composition; an
olive oil present at 2 to 36 percent by weight in said composition;
a sunflower oil present at 4 to 72 percent by weight in said
composition; a safflower oil present at 2 to 60 percent by weight
in said composition; and an anhydrous butter oil present at 2 to 36
percent by weight in said composition.
31. The lipid composition of claim 30, further comprising one or
more of the following: a mustard oil present at 8 percent or less
by weight in said composition, a flaxseed oil present at 8 percent
or less by weight in said composition, a palm oil present at 2
percent or less by weight in said composition, a coconut oil
present at 8 percent or less by weight in said composition, and a
soybean lecithin present at 4 percent or less by weight in said
composition.
32. A lipid-containing composition suitable for administration to a
mammalian subject wherein the lipid components are controlled based
on the seasonal climate of the subject's living area.
33. The composition of claim 32, wherein said seasonal climate has
a daytime high temperature range and said composition has
corresponding lipid components selected from the groups A through G
listed below, and wherein said temperature ranges are in degrees of
Fahrenheit (OF) and said lipid components comprise three or more
components selected from group entitled "Said Lipid Component
Group" below which corresponds to said daytime high temperature
range: TABLE-US-00021 The Approximate Group Range of Said Said
Lipid Component Group Reference Daytime High (Three or more
components are selected from each group corresponding to said No.
Temperature (.degree. F.) daytime high temperature) A 90 to 135 (1)
a sunflower oil present at 4 to 72 percent by weight in said
composition; (2) a peanut oil present at 2 to 68 percent by weight
in said composition; (3) a safflower oil present at 2 to 68 percent
by weight in said composition; (4) an anhydrous butter oil present
at 2 to 36 percent by weight in said composition; (5) almonds or an
almond oil present at 1 to 48 percent by weight in said
composition; (6) olives or an olive oil present at 2 to 33 percent
by weight in said composition; (7) cashews or a cashew oil present
at 2 to 37 percent by weight in said composition; (8) pumpkin seeds
or a pumpkin seed oil present at 3 to 54 percent by weight in said
composition; (9) sunflower seeds present at 1 to 15 percent by
weight in said composition; and (10) walnuts or a walnut oil
present at 2 to 33 percent by weight in said composition. B 70 to
99 (1) a sunflower oil present at 2 to 53 percent by weight in said
composition; (2) a peanut oil present at 2 to 53 percent by weight
in said composition; (3) an olive oil present at 2 to 30 percent by
weight in said composition; (4) a safflower oil present at 2 to 53
percent by weight in said composition; (5) an anhydrous butter oil
present at 2 to 30 percent by weight in said composition; (6)
almonds or an almond oil present at 1 to 49 percent by weight in
said composition; (7) olives present at 2 to 28 percent by weight
in said composition; (8) soybeans or a soybean oil present at 2 to
34 percent by weight in said composition; (9) cashews or a cashew
oil present at 2 to 31 percent by weight in said composition; (10)
pistachios or a pistachio oil present at 1 to 20 percent by weight
in said composition; (11) pumpkin seeds or a pumpkin seed oil
present at 3 to 46 percent by weight in said composition; (12)
sunflower seeds present at 1 to 15 percent by weight in said
composition; and (13) walnuts or a walnut oil present at 2 to 28
percent by weight in said composition. C 50 to 75 (1) a sunflower
oil present at 1 to 37 percent by weight in said composition; (2)
an olive oil present at 1 to 29 percent by weight in said
composition; (3) a safflower oil present at 1 to 29 percent by
weight in said composition; (4) an anhydrous butter oil present at
1 to 29 percent by weight in said composition; (5) almonds or an
almond oil present at 1 to 49 percent by weight in said
composition; (6) peanuts present at 1 to 33 percent by weight in
said composition; (7) almonds present at 2 to 47 percent by weight
in said composition; (8) olives present at 1 to 28 percent by
weight in said composition; (9) soybeans or a soybean oil present
at 1 to 34 percent by weight in said composition; (10) cashews or a
cashew oil present at 1 to 20 percent by weight in said
composition; (11) pistachios or a pistachio oil present at 1 to 17
percent by weight in said composition; (12) pumpkin seeds or a
pumpkin seed oil present at 2 to 45 percent by weight in said
composition; and (13) walnuts or a walnut oil present at 1 to 27
percent by weight in said composition. D 33 to 55 (1) a sunflower
oil present at 2 to 30 percent by weight in said composition; (2)
an olive oil present at 2 to 30 percent by weight in said
composition; (3) a safflower oil present at 2 to 30 percent by
weight in said composition; (4) an anhydrous butter oil present at
2 to 28 percent by weight in said composition; (5) almonds or an
almond oil present at 1 to 46 percent by weight in said
composition; (6) peanuts present at 2 to 38 percent by weight in
said composition; (7) olives present at 2 to 27 percent by weight
in said composition; (8) soybeans or a soybean oil present at 2 to
33 percent by weight in said composition; (9) cashews or a cashew
oil present at 1 to 18 percent by weight in said composition; (10)
pistachios or a pistachio oil present at 1 to 15 percent by weight
in said composition; (11) pumpkin seeds or a pumpkin seed oil
present at 3 to 43 percent by weight in said composition; (12)
sunflower seeds or a sunflower seed oil present at 1 to 10 percent
by weight in said composition; and (13) walnuts or a walnut oil
present at 2 to 26 percent by weight in said composition. E 0 to 37
(1) a sunflower oil present at 2 to 30 percent by weight in said
composition; (2) a corn oil present at 2 to 30 percent by weight in
said composition; (3) an olive oil present at 2 to 30 percent by
weight in said composition; (4) a safflower oil present at 2 to 30
percent by weight in said composition; (5) an anhydrous butter oil
present at 2 to 30 percent by weight in said composition; (6)
peanuts or peanut oil present at 3 to 47 percent by weight in said
composition; (7) almonds or an almond oil present at 1 to 48
percent by weight in said composition; (8) olives present at 2 to
28 percent by weight in said composition; (9) soybeans or a soybean
oil present at 2 to 34 percent by weight in said composition; (10)
pistachios or a pistachio oil present at 1 to 14 percent by weight
in said composition; and (11) walnuts or a walnut oil present at 2
to 27 percent by weight in said composition. F -50 to 5 (1) a
sunflower oil present at 2 to 30 percent by weight in said
composition; (2) a corn oil present at 2 to 30 percent by weight in
said composition; (3) an olive oil present at 4 to 60 percent by
weight in said composition; (4) a safflower oil present at 2 to 30
percent by weight in said composition; (5) an anhydrous butter oil
present at 2 to 30 percent by weight in said composition; (6)
peanuts or peanut oil present at 3 to 47 percent by weight in said
composition; (7) almonds or an almond oil present at 1 to 48
percent by weight in said composition; (8) olives present at 2 to
28 percent by weight in said composition; and (9) walnuts or a
walnut oil present at 2 to 27 percent by weight in said
composition. G -100 to -45 (1) a sunflower oil present at 2 to 30
percent by weight in said composition; (2) a corn oil present at 2
to 30 percent by weight in said composition; (3) an olive oil
present at 4 to 60 percent by weight in said composition; (4) a
safflower oil present at 2 to 30 percent by weight in said
composition; (5) an anhydrous butter oil present at 2 to 30 percent
by weight in said composition; (6) peanuts or peanut oil present at
3 to 47 percent by weight in said composition; (7) almonds or an
almond oil present at 1 to 48 percent by weight in said
composition; (8) olives present at 2 to 28 percent by weight in
said composition (9) soybeans or soybean oil present at 2 to 34
percent by weight in said composition; and (10) walnuts or a walnut
oil present at 2 to 27 percent by weight in said composition.
34. The composition of claim 32, further comprising one or more
additional components selected from one of the additional component
groups listed below corresponding to said daytime high
temperatures: TABLE-US-00022 The Approximate Group Range of Said
Said Additional Component Groups Reference Daytime High (One or
more said additional components are selected from a group No.
Temperature (.degree. F.) corresponding to said daytime high
temperature) A 90 to 135 (1) an avocado oil present at 15 percent
or less by weight in said composition; (2) a coconut oil present at
25 percent or less by weight in said composition; (3) a soybean
lecithin present at 1 percent or less by weight in said
composition; (4) a hemp oil present at 15 percent or less by weight
in said composition; (5) a perrilla oil present at 15 percent or
less by weight in said composition; (6) a rapeseed oil present at
15 percent or less by weight in said composition; (7) a cottonseed
oil present at 15 percent or less by weight in said composition;
(8) a rice bran oil present at 15 percent or less by weight in said
composition; and (9) a grape seed oil present at 15 percent or less
by weight in said composition. B 70 to 99 (1) an avocado oil
present at 15 percent or less by weight in said composition; (2) a
corn oil present at 15 percent or less by weight in said
composition; (3) a palm oil present at 5 percent or less by weight
in said composition; (4) a soybean lecithin present at 2 percent or
less by weight in said composition; (5) a fish oil present at 15
percent or less by weight in said composition; (6) a hemp oil
present at 15 percent or less by weight in said composition; (7) a
perrilla oil present at 15 percent or less by weight in said
composition; (8) a rapeseed oil present at 15 percent or less by
weight in said composition; (9) a cottonseed oil present at 15
percent or less by weight in said composition; (10) a rice bran oil
present at 15 percent or less by weight in said composition; (11) a
grape seed oil present at 15 percent or less by weight in said
composition; and (12) a coconut meat or oil present at 10 percent
or less by weight in said composition. C 50 to 75 (1) a mustard oil
present at 15 percent or less by weight in said composition; (2) a
fish oil present at 15 percent or less by weight in said
composition; (3) a peanut oil present at 35 percent or less by
weight in said composition; (4) a corn oil present at 15 percent or
less by weight in said composition; (5) a palm oil present at 5
percent or less by weight in said composition; (6) a soybean
lecithin present at 2 percent or less by weight in said
composition; (7) a hemp oil present at 15 percent or less by weight
in said composition; (8) a perrilla oil present at 15 percent or
less by weight in said composition; (9) a rapeseed oil present at
15 percent or less by weight in said composition; (10) a wheatgerm
oil present at 10 percent or less by weight in said composition;
(11) a cottonseed oil present at 15 percent or less by weight in
said composition; (12) a rice bran oil present at 15 percent or
less by weight in said composition; (13) a grape seed oil present
at 15 percent or less by weight in said composition (14) sunflower
seeds present at 10 percent or less by weight in said composition;
(15) sesame seeds or sesame oil present at 10 percent or less by
weight in said composition; (16) flaxseeds or flaxseed oil present
at 20 percent or less by weight in said composition; (17) macadamia
nuts or macadamia nut oil present at 10 percent or less by weight
in said composition; (18) brazil nuts or brazil nut oil present at
10 percent or less by weight in said composition; (19) hazelnuts or
hazelnut oil present at 10 percent or less by weight in said
composition; and (20) coconut meat or coconut oil present at 10
percent or less by weight in said composition. D 33 to 55 (1) a
mustard oil present at 15 percent or less by weight in said
composition; (2) a fish oil present at 15 percent or less by weight
in said composition; (3) a corn oil present at 15 percent or less
by weight in said composition; (4) a palm oil present at 5 percent
or less by weight in said composition; (5) a soybean lecithin
present at 2 percent or less by weight in said composition; (6) a
hemp oil present at 15 percent or less by weight in said
composition; (7) a perrilla oil present at 15 percent or less by
weight in said composition; (8) a rapeseed oil present at 15
percent or less by weight in said composition; (9) a wheatgerm oil
present at 10 percent or less by weight in said composition; (10) a
cottonseed oil present at 15 percent or less by weight in said
composition; (11) a rice bran oil present at 15 percent or less by
weight in said composition; (12) a grape seed oil present at 15
percent or less by weight in said composition (13) sesame seeds or
sesame seed oil present at 15 percent or less by weight in said
composition; (14) flaxseeds or flaxseed oil present at 15 percent
or less by weight in said composition; (15) macadamia nuts or
macadamia nut oil present at 15 percent or less by weight in said
composition; (16) brazil nuts or brazil nut oil present at 15
percent or less by weight in said composition; (17) hazelnuts or
hazelnut oil present at 15 percent or less by weight in said
composition; (18) pine nuts or a pine nut oil present at 15 percent
or less by weight in said composition; (19) chestnuts or a chestnut
oil present at 15 percent or less by weight in said composition;
and (20) a coconut meat or coconut oil present at 5 percent or less
by weight in said composition. E 0 to 37 (1) a mustard oil present
at 20 percent or less by weight in said composition; (2) a fish oil
present at 20 percent or less by weight in said composition; (3) a
palm oil present at 5 percent or less by weight in said
composition; (4) a soybean lecithin present at 2 percent or less by
weight in said composition; (5) a hemp oil present at 15 percent or
less by weight in said composition; (6) a perrilla oil present at
15 percent or less by weight in said composition; (7) a wheatgerm
oil present at 10 percent or less by weight in said composition;
(8) a cottonseed oil present at 15 percent or less by weight in
said composition; (9) a rice bran oil present at 15 percent or less
by weight in said composition; and (10) a grape seed oil present at
15 percent or less by weight in said composition. (11) sesame seeds
or sesame seed oil present at 15 percent or less by weight in said
composition; (12) flaxseeds or flaxseed oil present at 15 percent
or less by weight in said composition; (13) macadamias nuts or
macademia nut oil present at 15 percent or less by weight in said
composition; (14) brazil nuts or brazil nut oil present at 15
percent or less by weight in said composition; (15) hazelnuts or
hazelnut oil present at 15 percent or less by weight in said
composition; (16) pine nuts or a pine nut oil present at 15 percent
or less by weight in said composition; (17) chestnuts or a chestnut
oil present at 15 percent or less by weight in said composition;
(18) a coconut meat or coconut oil present at 5 percent or less by
weight in said composition; and (19) a rapeseed oil present at 30
percent or less by weight in said composition. F -50 to 5 (1) a
mustard oil present at 20 percent or less by weight in said
composition; (2) a fish oil present at 20 percent or less by weight
in said composition; (3) a palm oil present at 5 percent or less by
weight in said composition; (4) a soybean lecithin present at 2
percent or less by weight in said composition; (5) a hemp oil
present at 15 percent or less by weight in said composition; (6) a
perrilla oil present at 15 percent or less by weight in said
composition; (7) a rapeseed oil present at 30 percent or less by
weight in said composition; (8) a wheatgerm oil present at 10
percent or less by weight in said composition; (9) a cottonseed oil
present at 15 percent or less by weight in said composition; (10) a
rice bran oil present at 15 percent or less by weight in said
composition; (11) a grape seed oil present at 15 percent or less by
weight in said composition; (12) pistachios or a pistachio oil
present at 14 percent or less by weight in said composition; (13)
sesames or sesame oil present at 15 percent or less by weight in
said composition; (14) flaxseeds or a flaxseed oil present at 17
percent or less by weight in said composition; (15) macadamias or a
macadamia oil present at 15 percent or less by weight in said
composition; (16) brazil nuts or brazil nut oil present at 15
percent or less by weight in said composition; (17) hazelnuts or
hazelnut oil present at 15 percent or less by weight in said
composition; (18) pine nuts or a pine nut oil present at 15 percent
or less by weight in said composition; (19) chestnuts or a chestnut
oil present at 15 percent or less by weight in said composition;
and (20) a coconut meat or a coconut oil present at 5 percent or
less by weight in said composition. G -100 to -45 (1) a mustard oil
present at 20 percent or less by weight in said composition;
(2) a fish oil present at 20 percent or less by weight in said
composition; (3) a palm oil present at 5 percent or less by weight
in said composition; (4) a soybean lecithin present at 2 percent or
less by weight in said composition; (5) a hemp oil present at 15
percent or less by weight in said composition; (6) a perrilla oil
present at 15 percent or less by weight in said composition; (7) a
rapeseed oil present at 30 percent or less by weight in said
composition; (8) a wheatgerm oil present at 10 percent or less by
weight in said composition; (9) a cottonseed oil present at 15
percent or less by weight in said composition; (10) a rice bran oil
present at 15 percent or less by weight in said composition; (11) a
grape seed oil present at 15 percent or less by weight in said
composition; (12) pistachios or a pistachio oil present at 14
percent or less by weight in said composition; (13) sesames or
sesame oil present at 15 percent or less by weight in said
composition; (14) flaxseeds or a flaxseed oil present at 17 percent
or less by weight in said composition; (15) macadamias or a
macadamia oil present at 15 percent or less by weight in said
composition; (16) brazil nuts or brazil nut oil present at 15
percent or less by weight in said composition; (17) hazelnuts or
hazelnut oil present at 15 percent or less by weight in said
composition; (18) pine nuts or a pine nut oil present at 15 percent
or less by weight in said composition; (19) chestnuts or a chestnut
oil present at 15 percent or less by weight in said composition;
and (20) a coconut meat or a coconut oil present at 4 percent or
less by weight in said composition.
35. A lipid-containing composition suitable for administration to a
mammalian subject, wherein the subject is in an environment with a
given or forecasted ambient daily high temperature, and wherein the
lipid-containing composition and a temperature range of the given
or forecasted ambient daily high temperature are selected from the
group consisting of: the lipid-containing composition includes one
or more omega-9 lipid present in a range of 20 to 90 percent by
weight of total lipid, the lipid-containing composition includes
one or more omega-6 lipid present in a range of 4 to 60 percent by
weight of total lipid, the lipid-containing composition includes
one or more omega-3 lipid present in a range of 0.3 to 5 percent by
weight of total lipid, and the temperature range is from about 90
to about 135 degrees Fahrenheit; the lipid-containing composition
includes one or more omega-9 lipid present in a range of 20 to 90
percent by weight of total lipid, the lipid-containing composition
includes one or more omega-6 lipid present in a range of 4 to 60
percent by weight of total lipid, the lipid-containing composition
includes one or more omega-3 lipid present in a range of 0.5 to 6.0
percent by weight of total lipid, and the temperature range is from
about 70 to about 99 degrees Fahrenheit; the lipid-containing
composition includes one or more omega-9 lipid present in a range
of 20 to 90 percent by weight of total lipid, the lipid-containing
composition includes one or more omega-6 lipid present in a range
of 6 to 60 percent by weight of total lipid, the lipid-containing
composition includes one or more omega-3 lipid present in a range
of 0.8 to 7.0 percent by weight of total lipid, and the temperature
range is from about 50 to about 75 degrees Fahrenheit; the
lipid-containing composition includes one or more omega-9 lipid
present in a range of 10 to 80 percent by weight of total lipid,
the lipid-containing composition includes one or more omega-6 lipid
present in a range of 10 to 60 percent by weight of total lipid,
the lipid-containing composition includes one or more omega-3 lipid
present in a range of 1 to 8.0 percent by weight of total lipid,
and the temperature range is from about 33 to about 55 degrees
Fahrenheit; the lipid-containing composition includes one or more
omega-9 lipid present in a range of 10 to 80 percent by weight of
total lipid, the lipid-containing composition includes one or more
omega-6 lipid present in a range of 12 to 70 percent by weight of
total lipid, the lipid-containing composition includes one or more
omega-3 lipid present in a range of 1.5 to 9.0 percent by weight of
total lipid, and the temperature range is from about 0 to about 37
degrees Fahrenheit; the lipid-containing composition includes one
or more omega-9 lipid present in a range of 10 to 80 percent by
weight of total lipid, the lipid-containing composition includes
one or more omega-6 lipid present in a range of 13 to 70 percent by
weight of total lipid, the lipid-containing composition includes
one or more omega-3 lipid present in a range of 1.8 to 12.0 percent
by weight of total lipid, and the temperature range is from about
-50 to about 5 degrees Fahrenheit; and the lipid-containing
composition includes one or more omega-9 lipid present in a range
of 10 to 80 percent by weight of total lipid, the lipid-containing
composition includes one or more omega-6 lipid present in a range
of 15 to 73 percent by weight of total lipid, the lipid-containing
composition includes one or more omega-3 lipid present in a range
of 2.0 to 13.0 percent by weight of total lipid, and the
temperature range is from about -100 to about -45 degrees
Fahrenheit.
36. The composition of claim 35, further comprising one or both of
the following components: a vitamin E alpha present in a range of
0.005 to 0.2 percent by weight of total lipid; and a vitamin E
gamma present in a range of 0.001 to 0.04 percent by weight of
total lipid.
37. A lipid-containing composition suitable for administration to a
mammalian subject, comprising: total lipids which consist of one or
more monounsaturated lipids, one or more polyunsaturated lipids,
and one or more saturated lipids; wherein the subject is in an
environment with a given or forecasted ambient daily high
temperature; and wherein the lipid-containing composition and a
temperature range of the given or forecasted ambient daily high
temperature are selected from one of the following groups: the
ratio of the total lipids to the monounsaturated lipids is in a
range of 1.0:1.0 to 4.5:1.0, the ratio of the total lipids to the
polyunsaturated lipids is 1.7:1.0 to 15.0:1.0, and the ratio of the
total lipids to the saturated lipids is 2.0:1.0 to 10.0:1.0, and
the temperature range is from about 90 to about 135 degrees
Fahrenheit; the ratio of the total lipids to the monounsaturated
lipids is in a range of 1.0:1.0 to 4.5:1.0, the ratio of the total
lipids to the polyunsaturated lipids is in a range of 1.5:1.0 to
10.0:1.0, and the ratio of the total lipids to the saturated lipids
is in a range of 2.0:1.0 to 10.0:1.0, and the temperature range is
from about 70 to about 99 degrees Fahrenheit; the ratio of the
total lipids to the monounsaturated lipids is in a range of 1.0:1.0
to 4.5:1.0, the ratio of the total lipids to the polyunsaturated
lipids is in a range of 1.5:1.0 to 8.0:1.0, and the ratio of the
total lipids to the saturated lipids is in a range of 2.0:1.0 to
10.0:1.0, and the temperature range is from about 50 to about 75
degrees Fahrenheit; the ratio of the total lipids to the
monounsaturated lipids is in a range of 1.0:1.0 to 4.5:1.0, the
ratio of the total lipids to the polyunsaturated lipids is in a
range of 1.4:1.0 to 7.0:1.0, and the ratio of the total lipids to
the saturated lipids is in a range of 2.0:1.0 to 11.0:1.0, and the
temperature range is from about 33 to about 55 degrees Fahrenheit;
the ratio of the total lipids to the monounsaturated lipids is in a
range of 1.0:1.0 to 5.0:1.0, the ratio of the total lipids to the
polyunsaturated lipids is in a range of 1.3:1.0 to 6.5:1.0, and the
ratio of the total lipids to the saturated lipids is in a range of
2.0:1.0 to 11.0:1.0, and the temperature range is from about 0 to
about 37 degrees Fahrenheit; the ratio of the total lipids to the
monounsaturated lipids is in a range of 1.0:1.0 to 5.0:1.0, the
ratio of the total lipids to the polyunsaturated lipids is in a
range of 1.2:1.0 to 6.0:1.0, and the ratio of the total lipids to
the saturated lipids is in a range of 2.0:1.0 to 11.0:1.0, and the
temperature range is from about -50 to about 5 degrees Fahrenheit;
and the ratio of the total lipids to the monounsaturated lipids is
in a range of 1.0:1.0 to 5.0:1.0, the ratio of the total lipids to
the polyunsaturated lipids is in a range of 1.1:1.0 to 5.0:1.0, and
the ratio of the total lipids to the saturated lipids is in a range
of 2.0:1.0 to 11.0:1.0, and the temperature range is from about
-100 to about -45 degrees Fahrenheit.
38. The lipid-containing composition of claim 37, further
comprising one or both of the following components: a vitamin E
alpha present in a range of 0.005 to 0.2 percent by weight of total
lipid; and a vitamin E gamma present in a range of 0.001 to 0.04
percent by weight of total lipid.
39. A composition comprising safflower oil, sunflower oil, almond
oil, and anhydrous butter oil.
40. A composition comprising olive oil and sunflower oil, wherein
the amount of one or more omega-6 lipids in the composition is
greater than 20% of total lipids in the composition.
41. A composition comprising anhydrous butter oil wherein the ratio
of omega-6 lipids to omega-3 lipids in the composition is 8:1 to
12:1.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims priority to U.S. Patent Application
Ser. No. 61/046,747 filed on Apr. 21, 2008, U.S. Patent Application
Ser. No. 61/075,708 filed on Jun. 25, 2008, and U.S. Patent
Application Ser. No. 61/111,593 filed on Nov. 5, 2008, all of which
are incorporated by reference herein in its entirety for all
purposes.
BACKGROUND
[0002] Fatty acids play important physiological functions. They are
the building blocks of phospholipids and glycolipids, crucial
components of cell membranes. Fatty acids are the best biological
fuel molecules, capable of yielding more than twice as much energy
per gram as produced by carbohydrate or protein. Fatty acids
directly affect the functions of many proteins through covalent
modifications of such proteins. Fatty acids also affect membrane
fluidity and associated cellular processes. Fatty acids'
derivatives are also important hormones and biological messengers,
e.g., prostaglandins, thromboxanes, leukotrienes, lipoxins, and
resolvins. These hormones and messengers affect a broad range of
physiological functions such as vasal dilation, platelets
aggregation, pain modulation, inflammation, and cell growth.
[0003] The human and animal bodies synthesize many kinds of fatty
acids of various length of the carbon chain, with various numbers
and locations of double bonds. The addition of double bonds into a
fatty acid chain converts it into an unsaturated fatty acid, which
play significant roles in physiological functions. One way of
tracking the location of the double bond in an unsaturated fatty
acid molecule is by its distance from the distal carbon, i.e., the
omega-carbon. For example, the 18-carbon oleic acid, which has a
double bond at the 9.sup.th carbon from the omega position, is
called omega-9 fatty acid. Table 1 below describes various
unsaturated fatty acid groups named according to their double bond
locations relative to the omega position:
TABLE-US-00001 TABLE 1 General Descriptions of Relevant Fatty Acids
Name of Starting Molecule Fatty Acid General Formula for
Biosynthesis Omega-3 CH.sub.3--CH.sub.2--CH.dbd.CH--R--COOH
Alpha-Linolenic Acid Omega-6
CH.sub.3--(CH.sub.2).sub.4--CH.dbd.CH--R--COOH Linoleic Acid
Omega-7 CH.sub.3--(CH.sub.2).sub.5--CH.dbd.CH--R--COOH Palmitoleic
Acid Omega-9 CH.sub.3--(CH.sub.2).sub.7--CH.dbd.CH--R--COOH Oleic
Acid
[0004] As shown in the table above, Linoleic acid (LA) and
Alpha-linolenic Acid (ALA) are the precursors for all omega-6 and
omega-3 fatty acids. It is well established that LA and ALA are
"essential" fatty acids. They must be supplied in the diet because
the human and other mammalians cannot synthesize them from other
sources. Dietary deficiency or excess of the two essential fatty
acids may cause many illnesses. It is also well known that LA and
ALA share the same metabolic pathways, and that the excess of one
can increase the need for, or create a deficiency of, the other.
The latest science also shows evidence that non-essential fatty
acids can interfere with the activity and metabolism of essential
fatty acids, and that the quantity of dietary fat can also
influence the metabolism of fatty acids. ALA is known to be
preferentially metabolized by the human body depending on the
amount of the other fatty acids present in the diet.
[0005] Evidence also shows that antioxidants, phytochemicals, and
vitamins and minerals also play a role in metabolism of essential
fatty acids. Furthermore, human studies have identified that males
and females appear to differ in their ability to metabolize
essential fatty acids. It has been suggested that sex hormones play
a role in these differences. Molecules of polyunsaturated fatty
acids have a zigzag-like structure. Because they are flexible and
do not pack tightly, they stay fluid even at cold temperatures and
collectively lend flexibility to tissues. Hence, in colder climates
the human body benefits from greater amounts of polyunsaturated
fatty acids.
[0006] Numerous studies provide evidence for the prophylaxis and
treatment of medical conditions using supplementation with omega-3
fatty acids and recommendations to reduce omega-6 consumption. The
symptoms treated with such lipid profiles included menopause,
cardiovascular diseases, mental disorders, neural disorders,
musculoskeletal disorders, endocrine disorders, cancer, digestive
system disorders, symptoms of aging, viral infections, bacterial
infections, obesity, overweight, renal diseases, pulmonary
disorders, ophthalmologic disorders, dermatological disorders,
sleep disorders, dental diseases, and the diseases of the immune
system including autoimmunity. For example, U.S. Pat. No. 5,780,451
taught lipid formulations for patients with ulcerative colitis,
which include omega-3, omega-6, and omega-9 fatty acids. The
omega-3 content in these lipid formulations was several-fold higher
than that of omega-6. Similarly, a recently published U.S. patent
application, US2008/0039525, disclosed lipid compositions used for
diabetic patients, which contained omega-3, omega-6, and omega-9
fatty acids, with the specific ratio of omega-6 to omega-3 being
between 0.25:1 to 3:1.
[0007] The traditional emphasis on increasing omega-3 and reducing
omega-6 consumption often does not result in satisfactory relieves
because of the uncertainties introduced by dietary and demographic
factors. Accordingly, improved treatments, using improved lipid
compositions, for medical conditions are still needed. In fact, on
Jan. 26, 2009, for the first time the American Heart Association
issued an advisory to correct the perception that omega-6 are
unhealthy
(http://americanheart.mediaroom.com/index.php?s=43&item=650).
The current methodologies are confusing for the consumer, hence
lead to over consumption or under consumption of critical nutrients
with major health consequences.
BRIEF SUMMARY
[0008] The present disclosure relates to compositions and methods
for prophylaxis and/or treatment of medical conditions linked with
an imbalance in one or more lipids within context of other factors.
More particularly, the present disclosure relates to the use of
compositions and methods that use more advantageous sources of
omega-6 fatty acids, in the presence of nutritionally adequate
omega-3 fatty acids. The disclosure also relates to methods and
compositions that deliver omega-6 and omega-3 fatty acids along
with other nutrients that optimize the daily delivery and
bioavailability of omega-6 and omega-3 for prophylaxis and/or
treatment of medical conditions linked with an imbalance in one or
more lipids. This disclosure also relates to methods of steady
delivery of the bioactive substances, daily, weekly, monthly or
longer duration wide and sudden fluctuations of which may be
harmful. Furthermore, this disclosure also relates to methods of
daily delivery of essential fatty acids within the optimal range
with respect to the recommendations.
[0009] One general embodiment of the present disclosure is a
lipid-containing composition comprising optimal amounts of fatty
acids and phytochemicals for a mammalian subject based on one or
more factors selected from the group including the subject's age,
sex, diet, bodyweight, medical conditions, and the climate of the
subject's living area. Such composition is administered to a
subject through a steady delivery process, as explained later,
according to one embodiment of the disclosure. According to another
embodiment of the disclosure, the fatty acid components of the
composition's lipid contents are achieved at least in part by using
one or more of the following concentrated lipid sources: oils,
butters, nuts, and seeds.
[0010] Another embodiment of the disclosure is a lipid-containing
composition comprising polyunsaturated, monounsaturated, and
saturated fatty acids, wherein the ratios and amounts of said three
fatty acid types are controlled based on one or more of the
following factors for a mammalian subject: age, sex, climate, body
weight, diet, and medical conditions.
[0011] Another aspect of the present disclosure is a specific lipid
composition suitable for administration to a mammalian subject. One
embodiment of such composition comprises three or more of the
following substances (or the oil thereof) in certain defined
concentrations: peanuts, almonds, olives, soybeans, cashews,
flaxseeds, pistachios, pumpkin seeds, sunflower seeds, sesame
seeds, walnuts, anhydrous butter, and, coconut meat. Another
example of such composition comprises a safflower oil, sunflower
oil, peanut oil, almond oil, and anhydrous butter oil.
[0012] Another aspect of the present disclosure is directed at
methods of prophylaxis or treatment of a medical condition for a
mammalian subject, said method comprising administering a
therapeutically effective amount of balanced lipid formula to said
subject.
[0013] Yet another aspect of the present disclosure is directed at
methods of creating lipid and other nutrients-balanced diet by
combining special formulated lipid composition with lipid-free
food.
DETAILED DESCRIPTION
[0014] As used herein, "prophylaxis" refers to the preservation of
health, a preventive treatment, or a treatment meant to reduce the
risk of a medical condition.
[0015] As used herein, the term "treatment" in the context of a
medical condition refers to the management of the condition and may
or may not involve the complete amelioration of the condition.
[0016] As used herein, "medical condition" is a disease, disorder,
syndrome, and the like; or a symptom thereof.
[0017] As used herein a "lipid imbalance" refers to a
suboptimal/undesirable lipid profile in blood or other tissue of a
mammal, or a deficiency or excess of one or more lipids as compared
with a medical norm or as indicated by the manifestation of a
disorder. It is understood that the body's defense mechanisms (such
as storage of essential fatty acids among others) can help
compensate for a deficiency or excess of a particular fatty acid to
a limited extent.
[0018] As used herein a "therapeutically effective amount" is an
amount of a composition that results in the prophylaxis and/or
treatment of a medical condition or symptom of a medical condition.
In some embodiments, the adverse level of a biomarker or the
severity of a symptom of the medical condition is abated at least
10% or more, at least 25% or more, at least 50% or more, at least
75% or more, or 100% ameliorated.
[0019] As used herein the phrase "adequate amount of omega-3"
refers to a minimum of dietary reference intake (DRI) levels of
omega-3 per day from foods, supplements, and/or the lipid
compositions.
[0020] A "therapeutic effect," as that term is used herein,
encompasses a therapeutic benefit and/or a prophylactic benefit. By
therapeutic benefit is meant eradication or amelioration of the
underlying disorder being treated. Also, a therapeutic benefit may
be achieved with the eradication or amelioration of one or more of
the physiological symptoms associated with the underlying disorder
such that an improvement may be observed in the patient,
notwithstanding that the patient may still be afflicted with the
underlying disorder. For prophylactic benefit, the compositions may
be administered to a patient at risk of developing a particular
disease, or to a patient reporting one or more of the physiological
symptoms of a disease, even though a diagnosis of this disease may
not have been made. A prophylactic effect includes delaying or
eliminating the appearance of a disease or condition, delaying or
eliminating the onset of symptoms of a disease or condition,
slowing, halting, or reversing the progression of a disease or
condition, or any combination thereof.
Lipid Formulations
[0021] In one aspect, the present disclosure incorporates
relatively high ratio of omega-6 to omega-3 fatty acid, while
maintaining optimal daily delivery of both omega-6 and omega-3. One
reason for maintaining the high ratio is because of the
incorporation of nuts and nut oils as integral components of a
formulation, which nuts and nut oils have high antioxidants and
phytochemical content and other properties that render excessive
omega-3 unnecessary.
[0022] Certain embodiments of the present disclosure provide for
compositions comprising supplementation with one or more of
following: Vitamin A, B9 (folic acid), C, D, E; Carotenoids like
Beta-carotene, Lycopene, Lutein/Zeaxanthin; Flavonoids like
Anthocyanidins, Catechins, Flavonoles, Flavonones, Isoflavones,
Phytoestrogens including phytosterols, Quercetin, Organosulfurs,
Polyphenols including curcumin, and Sulfides; melatonin; one or
more anti-oxidant fatty acids such as ellagic acid and gallic acid,
anti-oxidants and phytochemicals in general; and anti-oxidant trace
elements Cu, Zn, Mn, Fe, Se, and Mg. In certain embodiments, each
of these supplements/nutrients may reduce the requirement for
omega-3 fatty acids and allow for a higher omega-6 to omega-3 ratio
than in the absence of said supplement(s)/nutrient(s). In certain
embodiments each of these nutrients is optimized through natural
sources such as oils, butters, nuts and seeds, herbs, sweeteners,
and other foods.
[0023] Nuts and seeds are plant embryos containing plant stem
cells. They are made to survive the harshest of the climactic
conditions until factors are suitable for germination. As such,
gram per gram, they are one of the richest sources of natural
nutrients. Almonds are one of the most nutritionally dense nuts,
providing an array of powerful nutrients: flavonoids, vitamin E,
manganese, magnesium, copper, vitamin B2 and phosphorus, to name a
few. The flavonoids found in nuts, particularly almond skins,
together with the vitamin E found in their meat double the
antioxidants that either delivers separately.
[0024] Walnuts, pecans and chestnuts have the highest antioxidant
content of the tree nuts, with walnuts delivering more than 20 mmol
antioxidants per 3 ounces, including at least 16 antioxidant
phenols, vitamin E, and ellagic and gallic acid. Walnuts are also
exceptionally high in their content of the omega-6 fatty acid
linoleic acid and the omega-3 fatty acid alpha-linolenic acid.
[0025] Peanuts also contribute significantly to dietary intake of
antioxidants, rivaling the antioxidant content of blackberries and
strawberries, and are far richer in antioxidants than apples,
carrots or beets. Peanuts are a good source of vitamin E (gamma-
and alpha-tocopherol), niacin, folate, proteins, and manganese.
Peanuts also contain high concentrations of phytochemicals
polyphenols, including resveratrol.
[0026] Sesame seeds are a very good source of manganese, copper,
calcium, magnesium, iron, phosphorus, vitamin B1, zinc and dietary
fiber. In addition to these important nutrients, sesame seeds
contain sesamin and sesamolin, phytosterols. Sesame seeds have the
highest total phytosterol content (400-413 mg per 100 grams) of all
nuts and seeds; pistachios and sunflower seeds are the second
richest (270-289 mg/100 g), closely followed by pumpkin seeds (265
mg/100 g).
[0027] A quarter cup of sunflower seeds may provide 31.9% of the
daily value for magnesium. Sunflower seeds are also a good source
of selenium. Cashews, flax seeds, pumpkin seeds, and sesame seeds
are a good source of magnesium. Almonds, cashews, sunflower seeds,
pumpkin seeds, walnuts, and sesame seeds are a good source of
copper. Almonds, flaxseeds, peanuts, sunflower seeds, pumpkin
seeds, and walnuts are a good source of manganese. Just one-quarter
cup of almonds may supply 45.0% of the daily value for manganese,
and 20.0% of the daily value for copper.
[0028] In one aspect, the disclosure provides compositions that
include seeds, nuts, and/or oils. In another aspect the
compositions include legumes, dairy, cocoa, lentils, and/or grains.
In one embodiment the composition can include one or more edible
oils, culinary nuts and/or seeds in their whole form or their oils
such as, but not limited to acai oil, amaranth oil, apple seed oil,
apricot kernel oil, argan oil, artichoke oil, avocado oil, babassu
oil, ben oil, blackcurrant seed oil, borage seed oil, borneo tallow
nut oil, bottle gourd oil, buffalo gourd oil, butter oil
(anhydrous), canola oil (rapeseed), cape chestnut oil, carob pod
oil, cocklebur oil, cocoa butter oil, cohune oil, coriander seed
oil, corn oil, cottonseed oil, dika oil, evening primrose oil,
false flax oil (camelina sativa), fish oil (cod liver), fish oil
(herring), fish oil (menhaden), fish oil (salmon), fish oil
(sardine), grapeseed oil, household lard, kapok seed oil,
lallemantia oil, marula oil, meadowfoam seed oil, mustard oil,
nutmeg butter, okra seed oil, palm oil, papaya seed oil, pequi oil,
perilla oil, prune kernel oil, quinoa oil, ramtil oil, rice bran
oil, royle oil, sacha inchi oil, safflower oil, sheanut oil,
soybean lecithin oil, tea oil, thistle oil, tomato seed oil,
ucuhuba butter oil, wheat germ oil, acorns, almonds, beech nuts,
brazilnuts, breadnuts, candlenuts, chestnuts, chilacayote nuts,
chilean hazel nuts, coconuts, cashews, colocynth nuts, filberts,
hazelnut, hickory, kola nut, macadamia, mamoncillo, mongongo,
obongo nut, olives, peanuts, pecans, pili nuts, pine nuts,
pistachios, soya nuts, poppy seeds, pumpkin seeds, hemp seeds, flax
seeds, sesame seeds, sunflower seeds, walnuts, and watermelon
seeds.
[0029] In some embodiments, the compositions of the present
disclosure include the following optimally balanced fatty acids and
combinations thereof. Saturated fatty acids: butyric (C4:0), lauric
(C12:0), myristic (C14:0), palmitic (C16:0), stearic (C18:0), and
arachidic (20:0); monounsaturated fatty acids: myristoleic (C14:1),
palmitoleic (C16:1), and omega-9 oleic (C18:1), gadoleic (C20:1),
erucic (C22:1), and nervonic (C24:1); and polyunsaturated fatty
acids: omega-6 linoleic (C18:2), conjugated-linoleic (C18:2),
gamma-linolenic (C18:3), eicosadienoic (C20:2),
di-hommo-gamma-linolenic (C20:3), and arachidonic (C20:4); and
omega-3 alpha-linolenic (C18:3), stearidonic (C18:4),
eicosapentaenoic (C20:5), docosapentaenoic (C22:5), and
docosahexaenoic (C22:6) fatty acids.
[0030] In some embodiments, synergy among complementing nutrients
from different sources may be incorporated. Furthermore, using
different sources avoids concentrated delivery of specific
phytochemicals that may be harmful in excess, since nuts and seeds
are known to have strong positive and negative outcomes. In one
embodiment, Ayurvedic principles (ancient Indian medicine proven
empirically over centuries) principles around the use of oils,
nuts, and seeds may be integrated with western molecular science to
design various lipid-containing compositions.
[0031] Given below in Table 2 are some examples of components of
oils. USDA website (http://www.nal.usda.gov/fnic/foodcomp/search/)
can be consulted for detailed components of various oils, nuts and
seeds.
TABLE-US-00002 TABLE 2 Relevant Components of Dietary Oils Peanut
Sunflower Oil Fish Oil Butter Oil Oil Corn Oil (high linoleic)
(herring) (Andy-drous) Coconut Oil Nutrient Units 1 tbsp 1 tbsp 1
tbsp 1 tbsp 1 tbsp 1 tbsp Total lipid (fat) g 13.5 13.6 13.6 13.6
12.73 13.6 Total Saturated Fatty g 2.281 1.761 1.401 2.895 7.926
11.764 Acids Total g 6.237 3.75 2.652 7.693 3.678 0.789
Monounsaturated Fatty Acids Total Polyunsaturated g 4.32 7.436
8.935 2.122 0.473 0.245 Fatty Acids Butyric Acid (C4:0) g 0.413
Caproic Acid (C6:0) g 0.244 0.082 Caprylic Acid (C8:0) g 0.142 1.02
Capric Acid (C10:0) g 0.319 0.816 Lauric Acid (C12:0) g 0.021 0.358
6.066 Myristic Acid (C14:0) g 0.014 0.003 0.977 1.281 2.285
Palmitic Acid (C16:0) g 1.282 1.439 0.802 1.592 3.349 1.115
Margaric Acid (C17:0) g 0.009 Stearic Acid (C18:0) g 0.297 0.251
0.612 0.111 1.543 0.381 Arachidic Acid g 0.189 0.059 (C20:0)
Behenic Acid (C22:0) g 0.378 Lignoceric Acid g 0.121 (C24:0)
Palmitoleic Acid g 0.014 0.016 1.626 0.285 (C16:1) Oleic Acid
(C18:1, n- g 6.048 3.717 2.652 3.203 0.789 9) Gadoleic Acid (C20:1,
g 0.176 0.018 1.853 n-9) Erucic Acid (C22:1, n- g 2.803 9) Linoleic
Acid (C18:2, g 4.32 7.278 8.935 0.156 0.288 0.245 n-6)
Alpha-linolenic Acid g 0.158 0.104 0.185 (C18:3, n-3) Arachidonic
Acid g 0.039 (C20:4, n-6) Eicosapentaenoic Acid g 0.853 (C20:5 n-3)
Docosapentaenoic g 0.084 Acid (C22:5 n-3) Docosahexaenoic Acid g
0.572 (C22:6 n-3) Vitamin A, RAE mcg 108 Retinol mcg 105 Carotene,
beta mcg 25 Vitamin A, IU IU 393 Vitamin E (alpha- mg 2.12 1.94
5.59 0.36 0.01 tocopherol) Tocopherol, beta mg 0.06 Tocopherol,
gamma mg 2.15 0.03 Tocopherol, delta mg 0.18 Vitamin K mcg 0.1 0.3
0.7 1.1 0.1 (phylloquinone) Phytosterols mg 28 132 14 12
[0032] In a related aspect, the disclosure provides compositions
that include polyunsaturated fatty acids, monounsaturated fatty
acids, saturated fatty acids, including omega-3, omega-6, and
omega-9 fatty acids. In some embodiments the composition is a
liquid formulation. In other embodiments the composition is a solid
formulation. In yet other embodiments the composition is a
semi-solid formulation. In certain embodiments, the composition can
substitute the unbalanced fats (cooking oils, fats, and the like)
that are typically added to various food preparations and/or
supplement fats contained in an individual's diet from other
sources. In certain embodiments, the entire diet is a composition,
balanced with respect to fatty acids, antioxidants, phytochemicals,
vitamins, and minerals. In certain embodiments, in addition to
normal lipid-containing ingredients, the disclosure may further
comprise herbs, spices, sweeteners, and additives. In some
embodiments, the disclosure includes compositions wherein the
ratios of omega-3, omega-6 and omega-9 are in an amount sufficient
to prevent the onset or progression of, protect from the severity
of or decrease a medical condition or disorder, or a symptom
thereof. In particular embodiments, the compositions described
herein are formulated with respect to one or more of an
individual's factors including but not limited to diet, gender,
age, size, weight, medical conditions, family medical history,
climate and other demographic factors. The compositions may be
delivered by any acceptable delivery method; in certain embodiments
vitamins and minerals may be added to the compositions, and in
certain embodiments, an additional vitamin and mineral supplement
may be administered.
[0033] In one embodiment, an individual with a herbivorous diet, an
ovo-lacto vegetarian diet, a vegan diet, or a high-antioxidant
high-phytochemical omnivorous diet may be administered related
compositions. In another aspect, an individual with a
low-antioxidant low-phytochemical herbivorous diet, a
low-antioxidant low-phytochemical ovo-lacto vegetarian diet, a
low-antioxidant low-phytochemical vegan diet, or a low-antioxidant
low-phytochemical omnivorous diet may be administered related
compositions. In another aspect, an individual may be administered
with compositions that are formulated with respect to whether his
or her diet comprises a low or high intake of seafood. This
pertains to concentrated lipid compositions. One method of
measuring antioxidant and phytochemical consumption is to measure
the number of fruits, vegetables, whole grains, and legumes
servings per day, where two or more per day may provide
high-antioxidant, high-phytochemical content. However, because
certain herbs such as turmeric may contain potent phytochemicals
(even in small quantities, e.g., a quarter-teaspoon), the
disclosure provides a number of different compositions, including
one with varying levels of omega-3 to suit a consumer's diet and/or
tolerance level. As used herein, "tolerance" and the like means the
ability of a consumer to withstand the composition without any
discomfort. In some embodiments, the compositions designed for
consumers with high seafood diet (two or more servings per week),
include low amount of nuts and seeds. In some instances, no nuts or
seeds. Other phytochemicals may also be minimized or eliminated as
part of a composition to avoid unfavorable interactions.
Administration
[0034] In some embodiments, the compositions comprising the lipid
formulation disclosed herein may be administered to an individual
in any orally accepted form. The lipid formulations may be packaged
in one, two, three, four or more mutually complementing daily
dosages. In some embodiments, they may be contained in any one or
more of, but not limited to, a single dosage or sustained and
controlled release capsule, soft-gel capsule, hard capsule, tablet,
powder, lozenge, or pill prepared in some instances with carriers
such as starches, sugars, diluents, granulating agents, lubricants,
binders, disintegrating agents, and the like; a powder or a
granule; a nutritional bar; a bakery food product such as a bread,
a dessert, a pastry, a truffle, a pudding or cake; a sealed single
dosage packet or resealable packaging containing a liquid, an oil
blend, a gel, a sauce, a dressing, a spread, a butter, drops, a
semi-solid; liquid, or the like; or a cooking oil such as a frying
oil, a pan-frying oil, a parting oil or the like. In some
embodiments, they may be unsealed and taken orally, or added as
part of a cooking ingredient to previously cooked or uncooked food
preparation with or without added fat. For example, they can be
made into special cooking oil, butter, dressing, etc. and be added
into foods while such foods are being prepared. The components of
the compositions may be delivered in one-part or multiple parts as
various components of a meal or to complement a meal, for example.
In some embodiments, the lipid-containing compositions may be
delivered using a gelatinous case, a vial, a pouch or a foil for
containing such compositions. In some embodiments, they may be part
of an enteral or parenteral formula, or a combination thereof. In
some embodiments a one-day, one-week, two-week, bi-weekly,
bimonthly, or monthly diet plan may be formulated comprising
various lipid formulations described herein, with varying
compositions administered each day.
[0035] The balanced lipid composition disclosed herein may be used
to create a completely balanced diet plan, by adding the
composition, which contains balanced components of lipids,
phytochemicals, antioxidants, vitamins, to name a few, into foods
as a dietary component. In one embodiment, a dietary component can
be a cooking ingredient added to prepared or unprepared food or
beverage. In some embodiments, it can also be a finished food
product such as a dessert or side dish, which are served together
with other components of a meal. Special foods containing no lipid
or low lipids (for example small amounts of lipids contained in
meats, poultry, seafood, milk, fruits, vegetables, and grains) may
be created to be used together with balanced lipid formulation to
ensure the complete balance of the lipid intake. Again, the
administration of the balanced composite nutrients may be achieved
through one course in a meal or multiple courses in a meal (e.g.,
salad, main course, and dessert).
[0036] Each individual may be given instructions on use of the
product, and risk and cautionary measures, as is usual with any
pharmaceutical, nutraceutical, or any product intended for
ingestion. Oils, nuts, seeds, and herbs are potent; therefore,
instructions may include recommended dosage, frequency, and
suggestions for optimization.
[0037] The delivery of the desired lipid composition may be
achieved through a one-part or multi-part delivery system. For
example, the desired formulation may be achieved through adding
various components to various parts of a meal, including bread,
salad, main course, and/or dessert.
[0038] One aspect of the disclosure is to deliver fatty acids in
such a way that the total daily delivery of omega-6 and omega-3
from the lipid composition and the rest of the diet are optimal
with respect to daily recommendations.
[0039] Yet another aspect of the present disclosure is the concept
of steady delivery of fatty acids, based on the observation that
each time there is a change in dietary lipid composition, it upsets
the body physiology, sometimes with adverse effects such as
headaches, muscle and joint pains, digestive and bowel upset,
mental confusion, and anxiety; and at other times it may cause
short-lived euphoria and general sense of wellness. Though the body
adapts to the change in 2-3 weeks or longer, long-term effects of
the change outside the optimal range may be harmful. Furthermore,
sudden large fluctuations in fatty acids can also have acute
adverse effects. This steady delivery requires a steady dosage
within the optimal range lasting approximately 2 to 3 weeks at a
minimum.
EXAMPLES
Example 1
Formulas with Various Lipid Ratios
[0040] In specific embodiments of the disclosure the formulations
described herein have high antioxidant and phytochemical content
and properties that render extra omega-3 unnecessary. In specific
embodiments sterols, sweeteners (such as honey), and herbs/spices
(such as curcumin) included in the compositions can render extra
omega-3 unnecessary. The formulations may provide a balanced fatty
acid composition of approximately 10-100 grams of total daily fat.
The formulations may include specific ratios of various lipid
components as shown below in Table 3. The ratios may be weight by
weight, weight by volume, or volume by volume (w/w, w/v, or
v/v).
TABLE-US-00003 TABLE 3 Lipid Ratios Approximate Lipid Component
Ratio Ratio Range Omega-6 to Omega-3 Fatty Acids 1:1-50:1 Omega-9
to Omega-6 Fatty Acids 0.5:1-6:1 Total Fatty Acids to
Monounsaturated Fatty Acids 1:1-15:1 Monounsaturated to
Polyunsaturated Fatty Acids 0.25:1-6:1 Monounsaturated to Saturated
Fatty Acids 0.25:1-7:1 Total Fatty Acids to Polyunsaturated Fatty
Acids 1:1-15:1 Total Fatty Acids to Saturated Fatty Acids
1:1-15:1
[0041] In some embodiments, the lipid formulation calls for
specific percentages of omega-9, omega-6, and omega-3 fatty acids,
as shown in Table 4 below.
TABLE-US-00004 TABLE 4 Contents of Various Unsaturated Fatty Acids
Content Lipid Name (w/w, w/v, or v/v of total lipids) Omega-9
10-90% Omega-6 4-75% Omega-3 0.1-30% Vitamin E-alpha/gamma
0.001-0.5%
Example 2
Lipid Compositions According to Climate
[0042] In one embodiment, compositions of the disclosure are
formulated as per climatic condition and ambient temperature range.
Table 5 provides % by weight ranges for a lipid formulation that
includes oils, nuts and seeds as disclosed by embodiments of the
present disclosure, by climatic condition and temperature
range.
TABLE-US-00005 TABLE 5 Lipid Formulation According to Climate % by
Weight Ranges by Temperature (in .degree. F.) BELOW HOT WARM COOL
COLD FREEZING ARCTIC POLAR 90.degree.-135.degree.
70.degree.-99.degree. 50.degree.-75.degree. 33.degree.-55.degree.
0.degree.-37.degree. -50.degree.-5.degree. -100.degree.--45.degree.
Low High Low High Low High Low High Low High Low High Low High Oils
Anhydrous Butter Oil 2 36 2 30 1 29 2 28 2 30 2 30 2 30 Avocado Oil
0 15 0 15 Coconut Oil 0 25 Corn Oil 0 15 0 15 0 15 2 30 2 30 2 30
Cotton seed oil 0 15 0 15 0 15 0 15 0 15 0 15 0 15 Fish Oil 0 15 0
15 0 15 0 20 0 20 0 20 Grapeseed oil 0 15 0 15 0 15 0 15 0 15 0 15
0 15 Hemp oil 0 15 0 15 0 15 0 15 0 15 0 15 0 15 Mustard Oil 0 15 0
15 0 20 0 20 0 20 Olive Oil 1 30 1 29 2 30 2 30 4 60 4 60 Palm Oil
0 5 0 5 0 5 0 5 0 5 0 1 Peanut Oil 2 68 2 53 0 35 Perrilla oil 0 15
0 15 0 15 0 15 0 15 0 15 0 15 Rapeseed Oil 0 15 0 15 0 15 0 30 2 30
0 30 0 30 Rice Bran Oil 0 15 0 15 0 15 0 15 0 15 0 15 0 15
Safflower Oil 2 68 2 53 1 29 2 30 2 30 2 30 2 30 Soybean Lecithin 0
2 0 2 0 2 0 2 0 2 0 2 0 1 Sunflower Oil 4 72 2 53 1 37 2 30 2 30 2
30 2 30 Wheatgerm oil 0 10 0 10 0 10 0 10 0 10 Nuts and Seeds
Almonds 3 48 3 49 2 47 3 46 3 48 3 48 3 48 Brazilnut 0 10 0 15 0 15
0 15 0 15 Cashews 2 37 2 31 1 20 1 18 Chestnut 0 15 0 15 0 15 0 15
Coconut 0 25 0 10 0 10 0 5 0 5 0 5 0 4 Flaxseed 0 20 0 15 1 10 0 17
0 17 Hazelnut 0 10 0 15 0 15 0 15 0 15 Macadamia Nuts 0 10 0 15 0
15 0 15 0 15 Olives 2 33 2 28 1 28 2 27 2 28 2 28 2 28 Peanuts 1 33
2 38 3 47 3 47 3 47 Pine nuts 0 15 0 15 0 15 0 15 Pistachios 1 20 1
17 1 15 1 14 0 14 0 14 Pumpkin seeds 3 54 3 46 2 45 3 43 Sesame 0
10 0 15 0 15 0 15 0 15 Soybeans 2 34 1 34 2 33 2 34 2 34 2 34
Sunflower Seeds 1 15 1 15 0 10 1 10 Walnuts 2 33 2 28 1 27 2 26 2
27 2 27 2 27
[0043] Table 6 provides % by weight ranges (% of weight of the
entire composition) for omega-9, omega-6, and omega-3 fatty acids
as disclosed by embodiments of the present disclosure, by climatic
condition and temperature range.
TABLE-US-00006 TABLE 6 Unsaturated Fatty Acid Contents According to
Climate % by Weight Ranges by Temperature (in .degree. F.) BELOW
HOT WARM COOL COLD FREEZING ARCTIC POLAR 90.degree.-135.degree.
70.degree.-99.degree. 50.degree.-75.degree. 33.degree.-55.degree.
0.degree.-37.degree. -50.degree.-5.degree. -100.degree.--45.degree.
Low High Low High Low High Low High Low High Low High Low High
Omega-9 Fats 20 90 20 90 20 90 10 80 10 80 10 80 10 80 Omega-6 Fats
4 60 4 60 6 60 10 60 12 70 13 70 15 73 Omega-3 Fats 0.3 5 0.5 6 0.8
7 1 8 1.5 9 1.8 12 2 13
[0044] In the following example, specific lipid compositions were
prepared for healthy individuals living in a variety of climates,
with a high antioxidant/phytochemical diet and/or a vegetarian
diet, for maintenance of general health and well-being. The
compositions were made up of a variety of oils, nuts and seeds, as
described below. The compositions as presented in the tables below
were formulated by three different methods: lipid liquid
formulation only, a solid or semi-solid nut and seed formulation
only, or a combination formulation containing oils, nuts and seeds.
The compositions were formulated to be administered in a once a day
format (combined formulation), or a twice a day format where one
administration was of the liquid lipid formation and the other
administration was of the solid nut and seed composition.
[0045] Table 7 provides the omega-6 to omega-3 ratio contained in
the lipid compositions of this example for a range of climates. The
ratios are presented, for any one of the liquid only, solid only,
or combination formulations.
TABLE-US-00007 TABLE 7 Ratio of Omega-6 (O6) to Omega-3 (O3) by
Climate O6:O3 Ratio by Climate (.degree. F.) Hot:
90.degree.-135.degree. 20:1 Warm: 70.degree.-99.degree. 18:1 Cool:
50.degree.-75.degree. 15:1 Cold: 33.degree.-55.degree. 13:1 Below
Freezing: 0.degree.-37.degree. 10:1 Arctic: -50.degree.-5.degree.
8:1 Polar: -100.degree.--45.degree. 7:1
[0046] Table 8 provides the ratio of total lipids to each of
monounsaturated, polyunsaturated, and saturated fatty acids in the
lipid compositions of this example, for a range of climates. The
ratios are presented, for any one of the liquid only, solid only,
or combination formulations.
TABLE-US-00008 TABLE 8 Ratio of Total Lipids to Specific Lipid
Components By Climate BELOW HOT WARM COOL COLD FREEZING ARCTIC
POLAR Ratios by Climate (.degree. F.) 90.degree.-135.degree.
70.degree.-99.degree. 50.degree.-75.degree. 33.degree.-55.degree.
0.degree.-37.degree. -50.degree.-5.degree. -100.degree.--45.degree.
Total Lipids:Monounsaturated 3.7 2.2 2.2 2.1 2.2 2.1 2.1 Fats Total
Lipids:Polyunsaturated 5.9 3.2 3.2 3.3 3.1 3.3 3.2 Fats Total
Lipids:Saturated 9.2 5.4 5.5 5.7 5.9 6.1 6 Fats
Example 3
Lipid Compositions Based on Age, Sex and Diet
[0047] One aspect of the disclosure is to supply lipid formulation
tailored to different human subjects based on their age and sex,
and diet. Table 9 below provides dose ranges for total fat content
in grams, the ratio range of monounsaturated fat to polyunsaturated
fat, and the ratio range of monounsaturated fat to saturated fat,
range of omega-6 content in grams, ratio range of omega-9 to
omega-6, range of omega-3 content in grams, and the ratio range of
omega-6 to omega-3 for vegetarian or high antioxidant and/or high
phytochemical consuming non-vegetarian subjects as disclosed by
embodiments of the present disclosure, by gender and age group.
TABLE-US-00009 TABLE 9 Lipid Dosages Based on Age and Sex for
Vegetarians and High Anti-Oxidant/Phytochemical Consuming Omnivores
Range Range Range Range Range Range Range Total Fat - g Mono:Poly
Mono:Sat O6 - g O9:O6 O3 - g O6:O3 Infants 7-12 mo 10-50 1:1-3:1
1:1-5:1 1-10 1:1-3:1 0.1-3 4:1-45:1 Children 1-3 y 10-60 1:1-3:1
1:1-5:1 2-15 1:1-3:1 0.1-3 4:1-45:1 Males 4-8 y 10-75 1:1-3:1
1:1-5:1 2-25 1:1-3:1 0.1-4 4:1-45:1 9-13 y 15-80 1:1-3:1 1:1-5:1
2-30 1:1-3:1 0.1-4 4:1-45:1 14-18 y 20-100 1:1-3:1 1:1-5:1 2-35
1:1-3:1 0.2-5 4:1-45:1 19-30 y 20-100 1:1-3:1 1:1-5:1 2-40 1:1-3:1
0.2-5 4:1-45:1 31-50 y 20-80 1:1-3:1 1:1-5:1 2-40 1:1-3:1 0.2-5
4:1-45:1 51-70 y 15-80 1:1-3:1 1:1-5:1 2-30 1:1-3:1 0.2-5 4:1-45:1
>70 y 15-80 1:1-3:1 1:1-5:1 2-30 1:1-3:1 0.2-5 4:1-45:1 Females
4-8 y 12-70 1:1-3:1 1:1-5:1 2-25 1:1-3:1 0.1-3 4:1-45:1 9-13 y
15-80 1:1-3:1 1:1-5:1 2-25 1:1-3:1 0.1-3 4:1-45:1 14-18 y 20-80
1:1-3:1 1:1-5:1 2-30 1:1-3:1 0.2-4 4:1-45:1 19-30 y 20-80 1:1-3:1
1:1-5:1 2-30 1:1-3:1 0.2-4 4:1-45:1 31-50 y 15-80 1:1-3:1 1:1-5:1
2-30 1:1-3:1 0.2-4 4:1-45:1 Pregnancy 24-100 1:1-3:1 1:1-5:1 2-35
1:1-3:1 0.2-5 4:1-45:1 Lactation 24-100 1:1-3:1 1:1-5:1 2-35
1:1-3:1 0.2-5 4:1-45:1 Menopause 15-80 1:1-3:1 1:1-5:1 2-30 1:1-3:1
0.2-4 4:1-45:1
[0048] Table 10 provides dose ranges for total fat content in
grams, the ratio range of monounsaturated fat to polyunsaturated
fat, and the ratio range of monounsaturated fat to saturated fat,
range of omega-6 content in grams, ratio range of omega-9 to
omega-6, range of omega-3 content in grams, and the ratio range of
omega-6 to omega-3 for non-vegetarian (i.e., omnivorous) or
low-antioxidant and/or low phytochemicals consuming vegetarian
subjects as disclosed by the present disclosure by gender and age
group.
TABLE-US-00010 TABLE 10 Lipid Dosages Based on Age and Sex for
Omnivores and Low Anti-Oxidant/Phytochemical Consuming Vegetarians
Range Total Range Range Range Range Range Range Fat - g Mono:Poly
Mono:Sat O6 - g O9:O6 O3 - g O6:O3 Infants 7-12 mo 10-50 1:1-3:1
1:1-5:1 1-10 1:1-3:1 0.1-3 1:1-10:1 Children 1-3 y 10-60 1:1-3:1
1:1-5:1 2-15 1:1-3:1 0.1-3 1:1-10:1 Males 4-8 y 10-75 1:1-3:1
1:1-5:1 2-20 1:1-3:1 0.2-5 1:1-10:1 9-13 y 15-80 1:1-3:1 1:1-5:1
2-25 1:1-3:1 0.2-5 1:1-10:1 14-18 y 20-100 1:1-3:1 1:1-5:1 2-30
1:1-3:1 0.3-6 1:1-10:1 19-30 y 20-100 1:1-3:1 1:1-5:1 2-35 1:1-3:1
0.3-6 1:1-10:1 31-50 y 20-80 1:1-3:1 1:1-5:1 2-35 1:1-3:1 0.3-6
1:1-10:1 51-70 y 15-80 1:1-3:1 1:1-5:1 2-25 1:1-3:1 0.3-6 1:1-10:1
>70 y 15-80 1:1-3:1 1:1-5:1 2-25 1:1-3:1 0.3-6 1:1-10:1 Females
4-8 y 12-70 1:1-3:1 1:1-5:1 2-20 1:1-3:1 0.2-4 1:1-10:1 9-13 y
15-80 1:1-3:1 1:1-5:1 2-20 1:1-3:1 0.2-4 1:1-10:1 14-18 y 20-80
1:1-3:1 1:1-5:1 2-25 1:1-3:1 0.3-5 1:1-10:1 19-30 y 20-80 1:1-3:1
1:1-5:1 2-25 1:1-3:1 0.3-5 1:1-10:1 31-50 y 15-80 1:1-3:1 1:1-5:1
2-25 1:1-3:1 0.3-5 1:1-10:1 Pregnancy 24-100 1:1-3:1 1:1-5:1 2-30
1:1-3:1 0.3-5 1:1-10:1 Lactation 24-100 1:1-3:1 1:1-5:1 2-30
1:1-3:1 0.3-5 1:1-10:1 Menopause 15-80 1:1-3:1 1:1-5:1 2-25 1:1-3:1
0.3-5 1:1-10:1
[0049] Table 11 provides dose ranges for total fat content in
grams, the ratio range of mono-unsaturated fat to polyunsaturated
fat, and the ratio range of monounsaturated fat to saturated fat,
range of omega-6 content in grams, ratio range of omega-9 to
omega-6, range of omega-3 content in grams and the ratio range of
omega-6 to omega-3 for high-seafood consumers as disclosed by the
present disclosure by gender and age group.
TABLE-US-00011 TABLE 11 Lipid Dosages Based on Age and Sex for
High-Seafood Consumers Range Total Range Range Range Range Range
Fat - g Mono:Poly Mono:Sat Range O6 - g O9:O6 O3 - g O6:O3 Infants
7-12 mo 10-50 1:1-3:1 1:1-5:1 1-10 1:1-3:1 0.1-3 2:1-30:1 Children
1-3 y 10-60 1:1-3:1 1:1-5:1 2-15 1:1-3:1 0.1-3 2:1-30:1 Males 4-8 y
10-75 1:1-3:1 1:1-5:1 2-25 1:1-3:1 0.1-4 2:1-30:1 9-13 y 15-80
1:1-3:1 1:1-5:1 2-30 1:1-3:1 0.1-4 2:1-30:1 14-18 y 20-100 1:1-3:1
1:1-5:1 2-35 1:1-3:1 0.2-5 2:1-30:1 19-30 y 20-100 1:1-3:1 1:1-5:1
2-40 1:1-3:1 0.2-5 2:1-30:1 31-50 y 20-80 1:1-3:1 1:1-5:1 2-40
1:1-3:1 0.2-5 2:1-30:1 51-70 y 15-80 1:1-3:1 1:1-5:1 2-30 1:1-3:1
0.2-5 2:1-30:1 >70 y 15-80 1:1-3:1 1:1-5:1 2-30 1:1-3:1 0.2-5
2:1-30:1 Females 4-8 y 12-70 1:1-3:1 1:1-5:1 2-25 1:1-3:1 0.1-3
2:1-30:1 9-13 y 15-80 1:1-3:1 1:1-5:1 2-25 1:1-3:1 0.1-3 2:1-30:1
14-18 y 20-80 1:1-3:1 1:1-5:1 2-30 1:1-3:1 0.2-4 2:1-30:1 19-30 y
20-80 1:1-3:1 1:1-5:1 2-30 1:1-3:1 0.2-4 2:1-30:1 31-50 y 15-80
1:1-3:1 1:1-5:1 2-30 1:1-3:1 0.2-4 2:1-30:1 Pregnancy 24-100
1:1-3:1 1:1-5:1 2-35 1:1-3:1 0.2-5 2:1-30:1 Lactation 24-100
1:1-3:1 1:1-5:1 2-35 1:1-3:1 0.2-5 2:1-30:1 Menopause 15-80 1:1-3:1
1:1-5:1 2-30 1:1-3:1 0.2-4 2:1-30:1
Example 4
Diet Formulations
[0050] In one embodiment, the total daily lipids from all foods are
within the ratios described herein and the compositions described
herein are administered to an individual that falls within the age
and calorie intake range as recommended.
[0051] In another embodiment, the lipid ratios and compositions
described herein are administered to an individual whose total diet
comprises 20%-45% of calories from fat (including from the lipid
compositions), 45%-65% calories from carbohydrates, and 10%-25%
calories from proteins. In one particular aspect, the total
calories consumed by the individual falls within the ranges as
daily recommended average, as per gender, age, and activity level,
to name a few.
[0052] In particular embodiments a meal plan may be established for
the subject to be followed in conjunction with the administration
of the composition.
[0053] In some embodiments, the lipid ratios and compositions
described herein are administered to an individual whose diet
comprises 20%-45% of calories from fat. In one aspect 60-90% of
calories from fat are supplied by the lipid compositions described
herein. In a further aspect the calories from fats are supplied by
one or more of fish oils, dairy products (butter, butter oil, milk,
milk cream, and/or cheese), fruit oils, vegetable oils, nuts,
seeds, nut oils, and seed oils.
[0054] In some embodiments, the lipid ratios and compositions
described herein are administered to an individual whose diet
comprises 45%-65% of total calories from carbohydrates. In another
aspect the diet comprises 45%-65% of total calories from
carbohydrates, which carbohydrates are from a 50%-70% intake of
grains in calories, 15%-30% intake of vegetables in calories, and
10%-30% intake of fruits in calories. In a related aspect the
calories from carbohydrates are additionally from one or more of
spices, sweeteners, and beverages. In a further aspect the 50%-70%
of carbohydrates from grains are supplied by one or more of wheat,
rice, corn, barley, spelt, oats, rye, buckwheat, millet, quinoa,
and other grains.
[0055] In some embodiments, the lipid ratios and compositions
described herein are administered to an individual whose diet
comprises 10%-25% of calories from proteins. In another aspect the
diet comprises 10%-25% of calories from proteins, which proteins
are from one or more of but not limited to legumes, eggs, cheese,
milk, yogurt, poultry, seafood, and meat.
[0056] In one embodiment, a diet plan is provided which includes
the 25%-45% of calories from fat, which are supplied by the lipid
compositions described herein. In a related embodiment, a 1-day, a
1-week, a 2-week, or a 1-month diet plan is provided which includes
the 20%-45% of calories from fat, of which 60-90% of fat calories
are supplied by the lipid compositions described herein. In one
diet plan, the remaining 45-65% of calories from carbohydrates and
10-25% of calories from proteins are supplied by a diet including
the following components, ranges specified in calories. [0057] a.
Calories from Carbohydrates 45-65% [0058] i. Grains 50-70% [0059]
1. Wheat<50% [0060] 2. Rice<50% [0061] 3. Corn<20% [0062]
4. Barley<20% [0063] 5. Spelt<20% [0064] 6. Oats<20%
[0065] 7. Rye<20% [0066] 8. Buckwheat<15% [0067] 9.
Millet<15% [0068] 10. Quinoa<15% [0069] 11. Other
Grains<10% [0070] ii. Vegetables 15-30% [0071] 1. Asparagus,
Bell Peppers, Cucumber, Eggplant, Green beans, Green peas, Kale,
Romaine, Spinach, Squash summer and winter, Tomato, Carrots,
Romaine Lettuce, Radish, Bitter Gourd, Okra, Fenugreek
Leaves<50% [0072] 2. Broccoli, Brussels Sprout, Cabbage, Chard,
Cauliflower, Mustard Greens, Collard Greens, Turnip Greens<40%
[0073] 3. Turnip, Beets, Potatoes, Yams, Sweet Potatoes<50%
[0074] 4. Fungi<25% [0075] 5. Other Vegetables<15% [0076]
iii. Fruits 10-30% [0077] 1. Apple, Apricot, Orange, Pear, Plum,
Banana, Cantaloupe, Grapes<75% [0078] 2. Grapefruit, Papaya,
Mango, Pineapple<50% [0079] 3. Blueberries, Cranberries, Figs,
Kiwi, Prune, Raspberries, Pomegranate, Strawberries,
Watermelon<30% [0080] 4. Other fruits<15% [0081] iv.
Spices<7% [0082] 1. Basil, Black pepper, Cayenne pepper, Chili
Pepper, Cinnamon, Cloves, Coriander seeds and leaves, Cumin, Dill,
Ginger, Mustard Seeds, Oregano, Peppermint leaves, Rosemary, Sage,
Thyme, Turmeric, Fennel, Garlic, Onion, Leeks, Parsley, Celery,
Cardamom, Saffron, Lime, Lemon, Tamarind, Mint, Vinegar, other
[0083] v. Sweeteners<7% [0084] 1. Molasses, Cane Juice, Honey,
Maple Syrup, Dates, Raisins, Dried Berries, Figs, Sugar, other
[0085] vi. Beverages<5% [0086] 1. Green tea, Black tea, cocoa,
coffee, alcohol, other<5% [0087] b. Calories from proteins
10-25% [0088] i. Legumes: Black beans, Dried Peas, Mung beans,
Garbanzo, Kidney beans, Lentils, Lima beans, Navy beans, Pinto
beans, Soybeans<75% [0089] ii. Eggs<25% [0090] iii.
Cheese<25% [0091] iv. Milk<25% [0092] v. Yogurt<25% [0093]
vi. Poultry<30% [0094] vii. Seafood<30% [0095] viii.
Meat<30% [0096] ix. Other<15%
Example 5
Formulation with Varied Omega-3 Fatty Acid Content
[0097] Table 12 provides dose ranges for total fat content in
grams, the ratio range of monounsaturated fat to polyunsaturated
fat, and the ratio range of monounsaturated fat to saturated fat,
range of omega-6 content in grams, ratio range of omega-9 to
omega-6, ratio range of omega-6 to omega-3, range of omega-3
content in grams designed by age and gender with increasing
strength of omega-3, low, medium, and high, such that the human
subject may choose the composition most agreeable to his/her diet,
where the selection may be based upon the level of antioxidants and
phytochemicals in the diet and/or medical predisposition.
TABLE-US-00012 TABLE 12 Lipid Dosages Based on Age and Sex for
Various Levels of Omega-3 Fatty Acids Low Med. High Range Strength
Strength Strength Total Range Range Range Range Range Range Range
Range Fat - g Mono:Poly Mono:Sat O6 - g O9:O6 O6:O3 O3 - g O3 - g
O3 - g Infants 7-12 mo 10-50 1:1-3:1 1:1-5:1 1-10 1:1-3:1 1:1-45:1
0.1-1.0 1.0-2.0 2.0-3.0 Children 1-3 y 10-60 1:1-3:1 1:1-5:1 2-15
1:1-3:1 1:1-45:1 0.1-1.0 1.0-2.0 2.0-3.0 Males 4-8 y 10-75 1:1-3:1
1:1-5:1 2-20 1:1-3:1 1:1-45:1 0.1-1.0 1.0-2.0 2.0-5.0 9-13 y 15-80
1:1-3:1 1:1-5:1 2-25 1:1-3:1 1:1-45:1 0.1-1.0 1.0-2.0 2.0-5.0 14-18
y 20-100 1:1-3:1 1:1-5:1 2-30 1:1-3:1 1:1-45:1 0.2-1.0 1.0-2.0
2.0-6.0 19-30 y 20-100 1:1-3:1 1:1-5:1 2-35 1:1-3:1 1:1-45:1
0.2-1.0 1.0-2.0 2.0-6.0 31-50 y 20-80 1:1-3:1 1:1-5:1 2-35 1:1-3:1
1:1-45:1 0.2-1.0 1.0-2.0 2.0-6.0 51-70 y 15-80 1:1-3:1 1:1-5:1 2-25
1:1-3:1 1:1-45:1 0.2-1.0 1.0-2.0 2.0-6.0 >70 y 15-80 1:1-3:1
1:1-5:1 2-25 1:1-3:1 1:1-45:1 0.2-1.0 1.0-2.0 2.0-6.0 Females 4-8 y
12-70 1:1-3:1 1:1-5:1 2-20 1:1-3:1 1:1-45:1 0.1-1.0 1.0-2.0 2.0-4.0
9-13 y 15-80 1:1-3:1 1:1-5:1 2-20 1:1-3:1 1:1-45:1 0.1-1.0 1.0-2.0
2.0-4.0 14-18 y 20-80 1:1-3:1 1:1-5:1 2-25 1:1-3:1 1:1-45:1 0.2-1.0
1.0-2.0 2.0-5.0 19-30 y 20-80 1:1-3:1 1:1-5:1 2-25 1:1-3:1 1:1-45:1
0.2-1.0 1.0-2.0 2.0-5.0 31-50 y 15-80 1:1-3:1 1:1-5:1 2-25 1:1-3:1
1:1-45:1 0.2-1.0 1.0-2.0 2.0-5.0 Pregnancy 24-100 1:1-3:1 1:1-5:1
2-30 1:1-3:1 1:1-45:1 0.2-1.0 1.0-2.0 2.0-5.0 Lactation 24-100
1:1-3:1 1:1-5:1 2-30 1:1-3:1 1:1-45:1 0.2-1.0 1.0-2.0 2.0-5.0
Menopause 15-80 1:1-3:1 1:1-5:1 2-25 1:1-3:1 1:1-45:1 0.1-1.0
1.0-2.0 2.0-4.0
Example 6
Formulation Based on Medical Conditions
[0098] In various embodiments, lipid compositions described herein
are administered to an individual for the prophylaxis and/or
treatment of diseases, disorders or conditions. For example, the
lipid formulation is used to alleviate symptoms of menopause, the
process of the cessation of menstruation. It is also used to
alleviate the symptoms of endocrine disorders.
[0099] Table 13 provides dose ranges for total fat content in
grams, the ratio range of monounsaturated fat to polyunsaturated
fat, and the ratio range of monounsaturated fat to saturated fat,
range of omega-6 content in grams, ratio range of omega-9 to
omega-6, range of omega-3 content in grams, and the ratio range of
omega-6 to omega-3 for subjects with medical indications as
disclosed by the present disclosure.
TABLE-US-00013 TABLE 13 Lipid Formulation Based on Medical
Conditions Range Range Range Range Range Range Range Total Fat - g
Mono:Poly Mono:Sat O6 - g O9:O6 O3 - g O6:O3 Menopause 15-100
1:1-3:1 1:1-5:1 2-30 1:1-5:1 0.2-4 1:1-45:1 Cardiovascular 15-100
1:1-3:1 1:1-5:1 2-35 1:1-5:1 0.1-6 1:1-45:1 Disease Mental
Disorders 15-100 1:1-3:1 1:1-5:1 2-30 1:1-5:1 0.1-6 1:1-45:1
Musculoskelatal 15-100 1:1-3:1 1:1-5:1 2-30 1:1-5:1 0.1-6 1:1-45:1
Disorders Symptoms of Aging 15-100 1:1-3:1 1:1-5:1 2-30 1:1-5:1
0.1-6 1:1-45:1 Endocrine Disorders 15-100 1:1-3:1 1:1-5:1 2-35
1:1-5:1 0.1-5 1:1-45:1 Viral Infections 15-100 1:1-3:1 1:1-5:1 1-30
1:1-5:1 0.1-4 1:1-45:1 Bacterial Infections 15-100 1:1-3:1 1:1-5:1
1-30 1:1-5:1 0.1-4 1:1-45:1 Obesity 15-100 1:1-3:1 1:1-5:1 1-40
1:1-5:1 0.1-6 1:1-45:1 Renal Diseases 15-100 1:1-3:1 1:1-5:1 1-30
1:1-5:1 0.1-6 1:1-45:1 Pulmonary Disorders 15-100 1:1-3:1 1:1-5:1
1-25 1:1-5:1 0.1-6 1:1-45:1 Opthalmologic 15-100 1:1-3:1 1:1-5:1
1-25 1:1-5:1 0.1-6 1:1-45:1 Disorders Dental Disorders 15-100
1:1-3:1 1:1-5:1 2-30 1:1-5:1 0.1-6 1:1-45:1 Cancer 15-100 1:1-3:1
1:1-5:1 1-35 1:1-5:1 0.1-6 1:1-45:1
Example 7
Lipid Composition According to Diet and Medical Condition
[0100] In one example lipid composition parameters were established
per diet or medical condition, intended for daily administration
(one or more components). As per Table 14 and Table 15 the
parameters of the compositions were established for an individual
whose diet is high in antioxidants/phytochemicals and/or is a
vegetarian; an individual whose diet is low in
antioxidants/phytochemicals and/or is a non-vegetarian, or an
individual presenting with a medical condition or disorder. The
compositions are made up of a variety of nut oils, seed oils,
vegetable oils, fruit oils, and other oils, nuts, and seeds. Table
14 presents the ratio ranges of polyunsaturated, monounsaturated,
saturated, omega-3, omega-6, and omega-9 fats. Table 15 presents
some composition with the specified ratios of polyunsaturated,
monounsaturated, saturated, omega-3, omega-6, and omega-9 fats.
TABLE-US-00014 TABLE 14 Lipid Composition in Ratio Ranges, by Diet
Type or Medical Condition Low High Antioxidant/ Antioxidant/ Phyto-
Phyto- chemical Individual chemical Diet with Diet and/or and/or
Non- Medical Vegetarian Vegetarian Issues Ratio Ranges by Diet Low
High Low High Low High Total Lipids:Monounsaturated 1.50 4.00 1.50
4.00 1.50 4.00 Fats Monounsaturated:Polyun- 1.00 3.00 1.00 3.00
1.00 3.00 saturated Fats Polyunsaturated:Saturated 1.00 3.00 1.00
3.00 1.00 3.00 Fats Monounsaturated:Saturated 1.00 4.00 1.00 4.00
1.00 4.00 Fats O9:O6 1.00 3.00 1.00 3.00 1.00 5.00 O6:O3 4.00 20.00
1.00 8.00 1.00 20.00 O9:O3 5.00 30.00 4.00 10.00 4.00 10.00 O9 % of
Total Lipids 22.86 91.43 21.62 86.49 22.86 91.43 O6 % of Total
Lipids 12.86 51.43 10.81 43.24 5.71 22.86 O3 % of Total Lipids 0.86
3.43 4.05 16.22 5.71 22.86
TABLE-US-00015 TABLE 15 Lipid Composition Ratios, by Diet Type or
Medical Condition Low Antioxidant/ High Antioxidant/ Phytochemical
Diet Phytochemical Diet and/or Non- Individual with Ratios and/or
Vegetarian Vegetarian Medical Issues Total Lipids:Monounsaturated
Fats 2.19 2.31 2.19 Monounsaturated:Polyunsaturated Fats 1.45 1.23
1.45 Polyunsaturated:Saturated Fats 1.38 1.63 1.38
Monounsaturated:Saturated Fats 2.00 2.00 2.00 O9:O6 1.78 2.00 4.00
O6:O3 15.00 2.67 1.00 O9:O3 26.67 5.33 4.00 O9 % of Total Lipids
45.71 43.24 45.71 O6 % of Total Lipids 25.71 21.62 11.43 O3 % of
Total Lipids 1.71 8.11 11.43
Example 8
Two-Component Lipid Formulation According to Diet and Medical
Condition
[0101] In one example liquid lipid and solid lipid composition
parameters were established per diet or medical condition, intended
for twice-a-day administration (i.e. 2 component daily
formulation). As per Table 16 to Table 19, the parameters of the
compositions were established for an individual whose diet is high
in antioxidants/phytochemicals and/or is a vegetarian; an
individual whose diet is low in antioxidants/phytochemicals and/or
is a non-vegetarian, or an individual presenting with a medical
condition or disorder. The compositions are made up of a variety of
nut oils, seed oils, vegetable oils, fruit oils, and other oils,
nuts, and seeds. Table 16 presents the ratios of polyunsaturated,
monounsaturated, saturated, omega-3, omega-6, and omega-9 fats for
the bar (solid) formulation. Table 17 presents the ratios of
polyunsaturated, monounsaturated, saturated, omega-3, omega-6, and
omega-9 fats for the liquid formulation. Table 18 presents examples
of bar formulation (solid) and Table 19 presents one liquid
composition with the specified ratio ranges of polyunsaturated,
monounsaturated, saturated, omega-3, omega-6, and omega-9 fats.
TABLE-US-00016 TABLE 16 Solid Lipid Composition in Ratios, by Diet
Type or Medical Condition In Bar Formulation Low Antioxidant/
2-Component Formulation, High Antioxidant/ Phytochemical Diet
Ratios Phytochemical Diet and/or Non- Individual with Ratios and/or
Vegetarian Vegetarian Medical Issues Total Lipids:Monounsaturated
Fats 2.33 2.56 2.40 Monounsaturated:Polyunsaturated Fats 1.50 1.13
1.25 Polyunsaturated:Saturated Fats 1.00 1.33 1.33
Monounsaturated:Saturated Fats 1.50 1.50 1.67 O9:O6 1.33 1.33 1.60
O6:O3 10.00 3.00 2.50 O9:O3 13.33 4.00 4.00 Omega-9 % of Total
Lipids 38.10 34.78 33.33 Omega-6 % of Total Lipids 28.57 26.09
20.83 Omega-3 % of Total Lipids 2.86 8.70 8.33
TABLE-US-00017 TABLE 17 Liquid Lipid Composition in Ratios, by Diet
Type or Medical Condition In Liquid Formulation Low Antioxidant/
2-Component Formulation, High Antioxidant/ Phytochemical Diet
Ratios Phytochemical Diet and/or Non- Individual with Ratios and/or
Vegetarian Vegetarian Medical Issues Total Lipids:Monounsaturated
Fats 1.87 2.00 2.25 Monounsaturated:Polyunsaturated Fats 1.67 1.36
1.00 Polyunsaturated:Saturated Fats 2.25 2.75 4.00
Monounsaturated:Saturated Fats 3.75 3.75 4.00 O9:O6 1.72 1.75 2.00
O6:O3 41.60 4.00 2.00 O9:O3 71.50 7.00 4.00 Omega-9 % of Total
Lipids 51.07 46.67 44.44 Omega-6 % of Total Lipids 29.71 26.67
22.22 Omega-3 % of Total Lipids 0.71 6.67 11.11
TABLE-US-00018 TABLE 18 Solid Lipid Composition in Ratio Ranges, by
Diet Type or Medical Condition Bar Formulation Low High
Antioxidant/ Antioxidant/ Phyto- Phyto- chemical Individual
chemical Diet with 2-Component Diet and/or and/or Non- Medical
Formulation, Ratio Vegetarian Vegetarian Issues Ranges Low High Low
High Low High Total Lipids:Monounsaturated 1.50 4.00 1.50 4.00 1.50
4.00 Fats Monounsaturated:Polyun- 1.00 3.00 1.00 3.00 1.00 3.00
saturated Fats Polyunsaturated:Saturated 1.00 3.00 1.00 3.00 1.00
3.00 Fats Monounsaturated:Saturated 1.00 4.00 1.00 4.00 1.00 4.00
Fats O9:O6 1.00 3.00 1.00 3.00 1.00 5.00 O6:O3 4.00 16.00 1.00 8.00
1.00 16.00 O9:O3 5.00 20.00 4.00 10.00 4.00 10.00 Omega-9 % of
Total Lipids 19.05 76.19 17.39 69.57 16.67 66.67 Omega-6 % of Total
Lipids 14.29 57.14 13.04 52.17 10.42 41.67 Omega-3 % of Total
Lipids 1.43 5.71 4.35 17.39 4.17 16.67
TABLE-US-00019 TABLE 19 Liquid Lipid Composition in Ratio Ranges,
by Diet Type or Medical Condition Liquid Formulation Low High
Antioxidant/ Antioxidant/ Phyto- Phyto- chemical Individual
chemical Diet with 2-Component Diet and/or and/or Non- Medical
Formulation, Ratio Vegetarian Vegetarian Issues Ranges Low High Low
High Low High Total Lipids:Monounsaturated 1.50 4.00 1.50 4.00 1.50
4.00 Fats Monounsaturated:Polyun- 1.00 3.00 1.00 3.00 1.00 3.00
saturated Fats Polyunsaturated:Saturated 1.00 3.00 1.00 3.00 1.00
4.00 Fats Monounsaturated:Saturated 1.00 4.00 1.00 4.00 1.00 4.00
Fats O9:O6 1.00 3.00 1.00 3.00 1.00 5.00 O6:O3 8.00 45.00 1.00 8.00
1.00 45.00 O9:O3 10.00 75.00 4.00 10.00 4.00 10.00 Omega-9 % of
Total Lipids 25.54 90 23.33 93.33 22.22 88.89 Omega-6 % of Total
Lipids 14.86 59.43 13.33 53.33 11.11 44.44 Omega-3 % of Total
Lipids 0.36 1.43 3.33 13.33 5.56 22.22
Example 9
Special Formulations Based on Diet
[0102] In this example one liquid lipid composition parameters was
established and one formulation was prepared, intended for once,
twice, or thrice or more a day administration to an individual
whose diet is high in antioxidants/phytochemicals and/or is a
vegetarian and to an individual who does not favor, or cannot
tolerate nuts and seeds. The compositions include a variety of nut
oils, seed oils, vegetable oils, fruit oils, and other oils. Some
ranges for a formulation are provided by % by weight (w/w) for each
component (representing the % weight for that individual component
on a daily basis). The compositions can be administered once or
more daily. Some compositions may include two or more of: almond
oil (4%-23%), anhydrous butter oil (5%-29%), avocado oil (1%-6%),
cashew oil (2%-15%), coconut oil (0%-2%), corn oil (3%-19%), fish
oil (0%-5%), flaxseed oil (0%-5%), mustard oil (0%-5%), olive oil
(3%-17%), palm oil (0%-5%), peanut oil (5%-30%), pistachio oil
(1%-7%), pumpkin seeds (1%-8%), safflower oil (high oleic) (1%-5%),
sesame oil (0%-50%), soybean lecithin (0%-5%), soybean oil (1%-7%),
sunflower oil (high oleic) (2%-14%), sunflower oil (regular)
(0%-5%), and/or walnut oil (3%-15%).
[0103] Another set of parameters for one liquid lipid composition
was established, intended for once, twice, or thrice a day
administration to an individual who does not favor, or can not
tolerate nuts and seeds. The compositions included a variety of nut
oils, seed oils, vegetable oils, fruit oils, and other oils. Some
ranges for a formulation are provided by % by weight (w/w) for each
component (representing the % weight for that individual component
on a daily basis). The ranges can accommodate
vegetarian/high-antioxidant/high-phytochemical user and
omnivore/low-antioxidant/low-phytochemical user or a seafood user,
in different combinations. The compositions can be administered
once or more daily. Some compositions may include two or more of:
almond oil (2%-36%), anhydrous butter oil (2%-36%), coconut oil
(0%-8%), corn oil (1%-24%), flaxseed oil (0%-8%), mustard oil
(0%-8%), olive oil (2%-36), palm oil (0%-2%), peanut oil (4%-72%),
pumpkin seeds oil (1%-24%), safflower oil (high oleic) (2%-60%),
soybean lecithin (0%-4%), sunflower oil (high oleic) (4%-72%),
and/or walnut oil (2%-36%).
Example 10
Daily Formulations
[0104] Liquid lipid and solid lipid composition parameters were
established for a twice-daily administration (i.e. 2-component
daily formulations). The compositions were made up of a variety of
nut oils, seed oils, vegetable oils, fruit oils, and other oils.
The ranges for each component of the liquid and solid formulations
are presented for each of the solid and liquid formulations. The
solid formulation includes two or more of by % weight of total
composition: almonds (10%-25%), cashews (7%-15%) coconut shredded
(1%-4%), flaxseed (0%-1%), olives (15%-25%), peanuts (4%-15%),
pistachios (2%-9%), pumpkin seeds (2%-12%), sesame (0%-0%),
soybeans (8%-20%), sunflower seeds (1%-4%), and/or walnuts
(5%-15%). The liquid formulation includes two or more of by %
weight of total composition: avocado oil (3%-14%), corn oil
(15%-30%), mustard oil (0%-2%), olive oil (10%-22%), palm oil
(0%-2%), peanut oil (15%-35%), safflower oil (high oleic) (5%-15%),
soybean lecithin (0%-2%), sunflower oil (high oleic) (10%-25%),
and/or anhydrous butter oil (5%-15%).
[0105] Some parameters were also established for one or more daily
administration (e.g., 1, 2 or 3 component daily formulation). The
compositions were made up of a variety of nuts, seeds, nut oils,
seed oils, vegetable oils, fruit oils, and other oils. The ranges
for each component of the formulations are presented for each of
the solid and liquid components. The formulation can include two or
more of by % weight of total composition: peanuts or peanut oil
(4-35), almonds or almond oil (2%-25%), olives or olive oil
(3%-45%), legumes or grains (15%-45%), cashews or cashew oil
(10%-40%), pistachios or pistachio oil (5%-25%), pumpkin seeds or
pumpkin seed oil (4%-25%), sunflower seeds or sunflower seed oil
(2%-30%), sesame seeds or sesame seed oil (0%-20%), walnuts or
walnut oil (5%-25%), flaxseed or flaxseed oil (0%-10%), anhydrous
butter oil or milk product including cheese (5%-45%), coconut meat
or coconut oil (2%-8%), corn oil (3%-20%), avocado oil (3%-8%),
safflower oil (2%-20%), mustard oil (0%-8%), palm oil (0%-8%),
and/or soybean lecithin (0%-2%).
Example 11
A Case Study on Menopause, Aging, and Musculoskeletal Disorders
[0106] A 47-year old female presented with menopause-related hot
flushes. The subject's diet was supplemented with a combination of
vegetable oils, seed oils, nuts and seeds for a period of 6 weeks.
The subject was provided with the twice-daily administration
formulation in Example 10. By optimizing omega-6 and omega-3 fatty
acids and ratios thereof, it was observed that there was an
adaptation period over which the intensity of hot flushes gradually
diminished. Other symptoms reduced were: night sweats, loss of
libido, vaginal dryness, fatigue, hair loss, sensitivity to hot and
cold, sleep disorders, difficulty concentrating, memory lapses,
weight gain, bloating, mood swings, depression, anxiety,
irritability, breast tenderness, migraines, aching joints, burning
tongue, the feeling of electric shocks, digestive problems, gum
problems, muscle tensions, itchy skin, and tingling in the
extremities, as reported by the subject. During the 6-week course
of treatment, the subject did improve her posture, which is
indicative of greater muscle mass, joint and/or tendon strength and
flexibility, and bone density. The effect on osteoporosis can be
tested by continuing the treatment with the supplement of oils,
nuts, and seeds over a longer period of time and measuring bone
density, using standard methods, before, during, and after
treatment.
[0107] It is likely that beneficial effects of treatment on the
menopause-related symptoms was due to achieving steady
sex-hormone-like benefit from omega-6 and omega-3 fatty acid
supplementation and optimization. The amount of dietary fat, its
composition, and the period during which the nutrient is fed to
animals is known to affect the secretion and metabolism of
androgens and endogenous steroids, and the presentation of sex
hormone receptor on the cell surface. Estrogens and polyunsaturated
fatty acids are also believed to have similar actions. Das UN.
Estrogen, statins, and polyunsaturated fatty acids: similarities in
their actions and benefits--is there a common link? Nutrition. 2002
February; 18(2):178-88. McVey M J, Cooke G M, Curran I H, Chan H M,
Kubow S, Lok E, Mehta R. Epub 2007 Sep. 11. Effects of dietary fats
and proteins on rat testicular steroidogenic enzymes and serum
testosterone levels. Food Chem Toxicol. 2008 January; 46(1):259-69.
Gromadzka-Ostrowska J. Effects of dietary fat on androgen secretion
and metabolism. Reprod Biol. 2006; 6 Suppl 2: 13-20. In addition to
amount and composition, relatively steady dosages may also be
important to reduce hormone fluctuations.
[0108] Nutrients from the total diet (natural sources) including
the lipid composition administered were as follows in Table 20.
TABLE-US-00020 TABLE 20 The Subject's Daily Nutrients Nutrient
Weight Protein g 60-100 Carbohydrate g 225-325 Total Lipids g 50-65
Calories 1700-1900 Cholestrol mg 150-300 Fiber g 30-45 Alpha
Carotene mcg 3000-4000 Beta Carotene mcg 10000-14000 Beta
Cryptoxanthin mcg 600-850 Betaine mg 20-50 Choline mg 150-250
Folate mcg 500-800 Lycopene mcg 1600-1900 Lutein Zeaxanthin mcg
10000-14000 Niacin mg 15-20 Pantothenic Acid mg 8-14 Retinol mcg
300-400 Riboflavin mg 2-3 Thiamin mg 1.5-2.5 Vitamin E Tocopherol
Beta mg 0.1-0.5 Vitamin E Tocopherol Delta mg 0.1-0.5 Vitamin E
Tocopherol Gamma mg 2.0-4.0 Vitamin E Tocopherol Alpha mg 10-15
Vitamin A IU 20000-30000 Vitamin A RAE 1500-1900 Vitamin B6 mg
1.5-2.5 Vitamin B12 mcg 2-5 Vitamin C mg 250-400 Vitamin D IU
200-400 Vitamin K mcg 300-550 Calcium mg 1200-1500 Copper mg 2-3
Iron mg 14-18 Magnesium mg 400-700 Manganese mg 6-8 Phosphorous mg
1600-1900 Potassium mg 3800-5500 Selenium mcg 65-80 Sodium mg
2000-2500 Zinc mg 10-14 Alanine g 2.5-4.5 Arginine g 3-4.5 Aspartic
acid g 6-8 Cystine g 1-2.5 Glutamic acid g 12-14 Glycine 2-4
Histidine g 1-3 Isoleucine g 2-4.5 Leucine g 4.5-7.5 Lysine g 4-5.5
Methionine g 1-2.5 Phenylalanine g 2.5-4.5 Proline g 4-6 Serine g
2.5-5.5 Threonine g 2-4 Tryptophan g 0.5-2 Tyrosine g 2-4 Valine g
3-5 Total Fat g 50-65 Monounsaturated g 18-25 Polyunsaturated g
12-16 Saturated g 12-15 Butyric acid 4:0 g 0.2-.75 Caproic acid 6:0
g 0.1-0.5 Caprylic acid 8:0 g 0.1-0.5 Caprice acid 10:0 g 0.2-0.6
Lauric acid 12:0 g 0.4-0.75 Myristic 14:0 g 1-3.0 Palmitic 16:0 g
3.0-7.0 Palmitoleic 16:1 g 0.25-1.5 Stearic 18:0 g 1.5-3.0 Oleic
18:1 g 16-22 Linoleic 18:2 g 11-14 Alpha-linolenic 18:3 g 0.8-1.5
Arachidic 20:0 g 0.1-1.0 Gadoleic (Eicosenoic) 20:1 g 0.1-.4
Arachidonic 20:4 g 0.01-0.5 Eicosapentaenoic 20:5 g 0-0.5 Erucic
22:1 g 0-.0.3 Docosapentaenoic 22:5 g 0-0.5 Docosahexaenoic 22:6 g
0.01-0.2 Phytosterols mg 90-150 Campesterol mg 0.8-1.5 Sitosterol
mg 15-30 Stigmasterol mg 0.3-1.5
Example 12
A Case Study on Hypercholesterolemia, Cardiovascular Disease
[0109] The host subject experienced hypercholesterolemia on a
vegetarian diet low in fat, mostly olive oil (75% monounsaturated
fat), a daily fish oil supplement of 1 gram, and a daily total
essential fatty acids (EFA) supplement of 1 gram. As part of the
treatment, the fish oil and EFA supplements were discontinued. The
subject was then administered a daily lipid composition supplement
containing 11 grams of omega-6 and 1.2 grams of omega-3, made up
primarily from a combination of vegetable oils, and nuts and seeds.
Administration of the lipid composition resulted in a reduction of
LDL from 160 mg to 120 mg. Very low levels of blood pressure were
observed, 90/55 mmHg, when omega-3 was increased to 1.8 grams;
blood pressure levels normalized at 105/70 mmHg at 11 grams of
omega-6 and 1.2 grams of omega-3. When omega-3 was reduced from 1.8
grams to 1.2 grams per day, the subject experienced an irregular
heartbeat, which subsided over a period of 2-3 weeks. However, when
omega-3 was further reduced to 0.5 grams per day, it resulted in an
ongoing arrhythmia.
[0110] This case study demonstrated that supplementation with
vegetable oils, nuts, and seeds, wherein the omega-6 to omega-3
ratio was about 9:1 results in a significant decrease in LDL
cholesterol blood levels (dyslipidemia which is associated with
atherosclerosis). This case study also demonstrated that the lipid
compositions and ratios described herein may be useful in
moderating blood pressure and arrhythmia.
[0111] In another human subject, intense muscle spasms arising from
the left thoracic cavity/wall were observed subsequent to a meal
high in omega-6, whereas the subject's typical diet included
primarily monounsaturated fatty acids and very small amounts of
saturated fatty acids. It is hypothesized, that sudden increase in
omega-6, when the body is chronically deficient may be harmful.
[0112] Polyunsaturated fats (omega-6, particularly gamma-linolenic
acid) have often been recommended to reduce coronary heart disease
along with recommendations to reduce saturated fatty acids. But all
saturated fats do not have the same effect on cholesterol synthesis
in the liver. Saturated fats of chain-length 12, 14 and 16 (lauric
acid, myristic acid and palmitic acid) have been shown to elevate
blood cholesterol. Stearic acid (18-carbon, saturated) has been
shown to lower cholesterol by 21%--even more than oleic acid
(18-carbon, monounsaturated), which lowers LDL by 15%.
Polyunsaturated fats increase cell membrane fluidity and therefore
tissue flexibility, including that of the arteries. It has been
suggested that reduced activity of Delta6 and Delta5 desaturases,
enzymes that metabolize essential fatty acids may be a factor in
the initiation and progression of atherosclerosis. A defect in the
activity of Delta6 and Delta5 desaturases may be a factor in the
initiation and progression of atherosclerosis. Prostaglandins
Leukot Essent Fatty Acids. 2007 May; 76(5):251-68. Epub 2007 Apr.
26. Certain phytochemicals have been shown to inhibit the enzymatic
activity. Fujiyama-Fujiwara Y, Umeda R, Igarashi O. Effects of
sesamin and curcumin on delta 5-desaturation and chain elongation
of polyunsaturated fatty acid metabolism in primary cultured rat
hepatocytes. J Nutr Sci Vitaminol (Tokyo). 1992 August;
38(4):353-63.
Example 13
A Case Study on Mood Swing, Mental Function
[0113] The subject host was placed on a trial of varying ratios of
omega-6 and omega-3 using various oils and nut combinations. Each
time omega-3 was reduced or omega-6 was increased the subject
became depressed and was given to crying at the slightest
provocation. When omega-3 was increased, it elevated the subject's
mood, immediately noticeable. However, within certain ranges of
omega-6 and omega-3, the effect was self-adjusting, e.g., over a
period of 3-6 weeks the moods normalized. It was also observed that
within that range of omega-6 and omega-3, over a period of 3-6
weeks the subject in fact was more grounded at higher levels of
omega-6; and was euphoric at higher levels of omega-3. Omega-3
increase enhanced cognitive function, which was immediately
noticeable. Omega-3 reduction caused confusion, dyslexia, and a
decline in cognitive function but these symptoms subsided with
time, again within certain omega-6 and omega-3 ranges. The subject
also displayed greater attention span and concentration after
omega-6 and omega-3 were optimized over a period of 3-6 weeks, with
greater reading speeds and comprehension. Thus, the subject
performed better at a lower level of omega-3, which suggests that
an adaptation mechanism was activated to compensate for the
required level of omega-6 metabolites. There may be a similar
adaptation mechanism for required level of omega-3. The cumulative
effects of such adaptations could pose a threat to the
individual.
[0114] Manipulation of dietary fats can alter the fatty acid
composition of brain-cell membranes, with effects on thought
processing and behavior. Polyunsaturated fatty acids could be
associated at different levels in the pathophysiology of major
depression, on one hand through their role in the membrane fluidity
which influences diverse steps of neurotransmission and, on the
other hand, through their function as precursors of
pro-inflammatory cytokines and eicosanoids disturbing
neurotransmission.
Example 14
Case Studies on Neural Disorders
1. Progressive Supra-nuclear Palsy
[0115] The subject host was a 50-year old woman whose symptoms
included dental sensitivity, deteriorating muscle mass, occasional
breathing difficulty, easy bruising, mild arrhythmia, and difficult
bowel movement. A dentist, as a solution to her sensitive teeth,
had extracted and replaced her teeth with dentures at 50. Each of
her other symptoms was treated as a stand-alone symptom and treated
with non-lipid medications. At 60 she developed loss of balance,
diplopia (double vision), and slurry speech. Eventually when she
started having bone-shattering falls, she was diagnosed with
Progressive Supra-nuclear Palsy (PSP), a neurological disease
mainly characterized by loss of neural tissue in the brainstem. The
subject then lost ambulation and speech, and developed dysphagia.
She passed away at 67 from pneumonia.
[0116] The woman had had four healthy deliveries, a healthy life
until 50, and had no incidence of neural disease in her family.
Closer examination of changes in her life around 50 revealed that
around that time the fats in her diet had been significantly cut
back because of the prevalent doctrine in the 1980s that fats cause
heart-disease, and that all fats are deleterious. Both of the
woman's parents in their early 70s, and a brother at 48, had died
of heart attacks. Hence, the fat reduction was a precautionary
measure to avoid cardiac disease, which was then believed to have a
strong genetic component. However, it is hypothesized in the
present disclosure that the fats were cut to a point where she
became severely deficient in both omega-6, and omega-3 fatty acids.
The woman was a postmenopausal vegetarian with high antioxidant and
phytochemicals intake, and the little fat that was in her diet was
either saturated fat (less than 20% of total fat) or
monounsaturated fat (70-90% of total fat), mostly olive oil
following the then doctrine that held olive oil above all others.
Olive oil is 75% monounsaturated oil and rich in polyphenols. Since
all fatty acids compete for the same enzymes in the metabolic
pathway and antioxidants and phytochemicals increase the
requirement for omega-6, in her case the deficiency of omega-6 acid
appears to be the culprit. The deficiency of omega-6 is also
evident from her early symptoms: muscle mass requires a balance of
omega-6 and omega-3, lack of omega-6-derivative leukotrienes would
lead to asthma-like breathing issues (conversely excessive
leukotrienes can also lead to asthma like symptoms), deficiency of
omega-3 has been linked with arrhythmia, and deficiency of omega-6
derived thromboxanes would lead to easy bruising, and lack of
omega-6 derived prostaglandins will impede smooth muscle activity
and therefore the bowel movement. The fact that she was
post-menopausal made the requirement of omega-6 and omega-3 more
critical, since estrogen and androgens, as hypothesized in the
present disclosure, have similar actions and benefits as
polyunsaturated fats. When the reproductive hormones decline, the
body increasingly depends on omega-6 and omega-3 for the
physiological functions.
[0117] It is an embodiment of the present disclosure, that
deficiency of LA metabolite Arachidonic acid (AA) and ALA
metabolite docosahexaenoic acid (DHA), that are so abundantly
present in neural tissue, particularly the membranes of neural
synapses, may have caused the neurodgeneration. Neuroinflammation
is a host defense mechanism associated with neutralization of an
insult and restoration of normal structure and function of brain,
and is characteristic of all major neural diseases. The dietary
deficiency of LA and ALA, and the resulting unfavorable tissue
ratio of AA to DHA might have affected the neurodegeneration
associated with acute neural trauma and neurodegenerative
disease.
[0118] It is important to note that not all omega-6 or omega-3
deficiencies or imbalance lead to PSP. It simply creates a distress
in the body; the disease developed depends on rest of the body
chemistry. In the Western world omega-3 has received much attention
because of the populace's consumption was highly skewed towards
omega-6 and that with inadequate antioxidant and phytochemical
intake. Requirement of omega-3 is very small, and increases only
with the increase in omega-6. Disclosed herein are methods and
compositions to balance omega-3 and omega-6, in light of
demographic factors, and for their steady delivery.
2. Amyotrophic Lateral Sclerosis
[0119] The subject was a vegetarian woman in her mid-30s, on a low
fat diet using primarily olive oil and nuts. She had developed
Amyotrophic Lateral Sclerosis (ALS)-like symptoms: muscle weakness
in hands, arms, legs, and the muscles of speech, twitching and
cramping of muscles, shortness of breath, and difficulty in
swallowing. The left side of her body was affected more than the
right side. Upon administration of a lipid composition and changes
in diet that increased omega-6 to about 12 grams, her symptoms
disappeared and the muscle tone improved, better than before the
onset of symptoms. It is hypothesized that in this instance, the
amount of omega-3 relative to omega-6 in the tissue had exceeded
the ratio tolerated by the body. Since the vegetarian diet and nuts
contributed plenty of antioxidants and phytochemicals, the subject
became deficient in omega-6, despite moderate levels of
omega-3.
[0120] The initial symptoms of ALS can be quite varied in different
people. One person may experience tripping over carpet edges,
another person may have trouble lifting and a third person's early
symptom may be slurred speech. In a small number of people, ALS is
known to remit or halt its progression, though there is no
scientific understanding as to how and why this happens. The
inventor hypothesizes that it has to do with inadvertent change in
omega-6 and omega-3 fatty acids. Most of us fall into certain food
patterns based on likes and dislikes, habits inherited from family,
accessibility of certain foods, cooking habits, and the foods that
happen to be in vogue. But, there is always that change in life, a
dinner party at a friend's, food gift from a well-wisher, or a
vacation to a remote locale, or a new oil that one takes a liking
to, which brings about change in diet. All it takes is a handful of
nuts, or a spoonful of high-omega-6 and/or omega-3 oil to tip the
balance, even if temporarily. However little, it does register in
the body.
[0121] Subsequent to the experimental adjustment of omega-6 and
omega-3 levels in other host subjects the inventor observed,
improvement in motor coordination, handwriting, balance, and body's
ability to follow a rhythm, in dance steps, for example.
Example 15
Case Studies on Musculoskeletal Disorders
1. Muscular Performance
[0122] In a subject host, the inventor observed many
musculoskeletal issues appear and disappear in the course omega-6
and omega-3 therapy by administration of lipid compositions.
Increases in omega-3 beyond 0.5 g, in a vegetarian host with
omega-6 at 10-11 grams, yielded better muscular performance, lesser
joint pain, lesser joint crackling sounds, and better spatial task
performance. But a point of diminishing marginal returns was
reached at about 1.2 grams of omega-3. Increases of omega-3 beyond
1.2 grams resulted in weaker muscle tone, posture, and exercise
endurance. When the omega-3 was gradually brought back to 1.2
grams, the subject experienced leg cramps, lower back pain, burning
sensation in the scalp, buckling of knee joints, and joint pains in
knees and shoulders. Over a period of 3-6 weeks these symptoms
subsided.
2. Gout
[0123] In another subject host, the inventor observed the
development of Gout, a joint disorder, on a low-fat diet, primarily
olive oil, and nuts. The symptoms disappeared upon increase of
omega-6 in the diet.
3. Myofascial Pains and Thoracic Outlet Syndrome
[0124] In a 35-year old vegetarian female, on a low-fat diet using
olive oil as the main fat in the diet, the development of episodes
of acute myofascial pains was observed. The subject experienced
severe muscle tightness in several areas of the body, neck
shoulders, para-spinal muscles, thighs, hands, and arms.
[0125] The host was diagnosed with Myofascial Pain Syndrome (MFS)
and Thoracic Outlet Syndrome (TOS). TOS consists of a group of
distinct disorders that affect the nerves in the brachial plexus
(nerves that pass into the arms from the neck) and the subclavian
artery and vein blood vessels between the base of the neck and
axilla (armpit). For the most part, these disorders are produced by
compression of the components of the brachial plexus (the large
cluster of nerves that pass from the neck to the arm), the
subclavian artery, or the subclavian vein. Neurogenic form of TOS
accounts for 95-98% of all cases of TOS, hence neural disease was
suspected. The host subject went through numerous examinations
including: MRIs of the entire CNS, X-rays, blood work, drug
therapies, massage therapies, and chiropractic treatment. The
symptoms would go away and then reappear a few months or a year
later. After the inventor optimized the omega-6 and omega-3 in the
subject's diet by administration of lipid compositions the episodes
of TOS and myofascial pains subsided. It is hypothesized herein
that these episodes were the result of the body being severely
deficient in omega-6 and omega-3. Each time there was an
inadvertent increase in omega-6 and omega-3, which can occur by any
incidental changes in diet, there was a sudden surge in
prostaglandins, thromboxanes, and leukotrienes, resulting in severe
muscular tightening. Other mechanisms related to the lipids may be
involved that are not yet understood.
[0126] Fatty acids' relationship with musculoskeletal disorders is
very intricate. There are many studies demonstrating that
arachidonic acid and other polyunsaturated fatty acids modulate the
function of voltage gated calcium, sodium, and potassium channels,
primarily in neural and muscle cells impacting the excitability of
the cells. Boland L M, Drzewiecki M M. Polyunsaturated Fatty Acid
modulation of voltage-gated ion channels. Cell Biochem Biophys.
2008; 52(2):59-84. Epub 2008 Oct. 2. In some studies changes in
muscle fiber type may be observed with changes in amount and type
of fatty acids. de Wilde J, Mohren R, van den Berg S, Boekschoten
M, Dijk K W, de Groot P, Muller M, Mariman E, Smit E. Short-term
high fat-feeding results in morphological and metabolic adaptations
in the skeletal muscle of C57BL/6J mice. Physiol Genomics. 2008
Feb. 19; 32(3):360-9. Epub 2007 Nov. 27. On the skeletal side, bone
mass is governed by balanced action of osteoblasts (bone forming
cells) and osteoclast (bone resorbing cells). There is increasing
evidence that various long-chain polyunsaturated fatty acids and
their metabolites affect calcium balance, osteoblastogenesis,
osteoclastogenesis, and osteoblast and osteoclast function. Poulsen
R C, Moughan P J, Kruger M C. Long-chain polyunsaturated fatty
acids and the regulation of bone metabolism. Exp Biol Med
(Maywood). 2007 November; 232(10):1275-88. Rahman M M, Bhattacharya
A, Fernandes G. Docosahexaenoic acid is more potent inhibitor of
osteoclast differentiation in RAW 264.7 cells than eicosapentaenoic
acid. J Cell Physiol. 2008 January; 214(1):201-9.
Example 16
A Case Study on Thyroid Disturbances
[0127] In a host subject, symptoms of thyroid disturbance with a
decrease in omega-3, fatigue and weakness, cold intolerance, hair
loss, cold hands and feet, weight gain, insomnia, constipation,
depression, poor memory, forgetfulness, and nervousness were
observed.
Example 17
A Case Study on Weight Gain, Obesity
[0128] In a vegetarian host subject it was discovered that there
was a band of optimal quantity and ratio of omega-6 and omega-3,
beyond which the subject gained weight. At omega-6 of 11 grams and
omega-3 of 2 grams, the subject was at 134 lbs. When the inventor
gradually reduced omega-3 to 1.2 grams, the subject initially
gained 6 lbs., and then after 6 weeks, lost 12 lbs. for an ending
weight of 128 lbs. Obesity often has been linked to slow
metabolism. In turn, metabolic rate has been linked to
cell-membrane composition. Hulbert A J. Membrane fatty acids as
pacemakers of animal metabolism. Lipids. 2007 September;
42(9):811-9. Epub 2007 Apr. 27. High polyunsaturated membrane
composition may be linked with fast membrane associated processes.
Membrane composition influences all aspects of the energy balance
equation: electrolyte gradient balance, neuropeptide regulation,
gene regulation and glucose regulation.
Example 18
A Case Study on Diabetes
[0129] Varying quantities and ratios of omega-6 and omega-3 were
administered on otherwise healthy subjects to see if very early
symptoms of diabetes could be induced. High blood sugar, excessive
urine production, excessive thirst and increased fluid intake,
blurred vision, unexplained weight gain and lethargy were induced
by certain ratios of omega-6 and omega-3 fatty acids. These
simulated symptoms with very high levels of omega-3 may also be
reversed by reducing the dosage. In one instance, insulin
resistance may be associated with low levels of omega-6 fatty
acids. Summers L K, Fielding B A, Bradshaw H A, Ilic V, Beysen C,
Clark M L, Moore N R, Frayn K N. Substituting dietary saturated fat
with polyunsaturated fat changes abdominal fat distribution and
improves insulin sensitivity. Diabetologia. 2002 March;
45(3):369-77.
Example 19
A Case Study on Digestive System Disorders
[0130] In the host subject, incidences of acid reflux disease,
irritable bowels, indigestion, and dyspepsia were observed. Each
time omega-6 was increased or omega-3 was decreased the following
symptoms appeared: stomach pain, bloating, heartburn, nausea (upset
stomach), and burping; but they all disappeared as the body
adjusted to increased omega-6. Omega-6 was tested up to 11 grams.
It is hypothesized that beyond that point in the particular host
the symptoms would persist. Increasing omega-3 beyond 2 grams
caused tight dark pellet-like stools. In the optimal omega-6 and
omega-3 balance, bile production was optimal as determined by the
yellowish brown color of the stools. It was also observed that
mucus production in the alimentary canal was optimal with the
proper omega-6 and omega-3 quantities and ratio, using mucus
production in the oral cavity as an indicator. Halitosis was also
observed with 2 grams of omega-3, and got worse when omega-3 was
reduced, and then normalized over a period of 3-6 weeks.
Arachidonic acid plays a pivotal role in protection and integrity
of the intestinal mucosa. Excessive omega-3 can displace
arachidonic acid leading to gastro-intestinal mucosal damage.
Example 20
A Case Study on Ovulation, Reproductive Disorders
[0131] In a host subject, a 35-year old female, cessation of
ovulation (as indicated by watery pale menstrual cycles), intense
ovulation-related pains and anovulatory menstruation at extremely
low omega-6 in diet were observed; olive oil being the main fat
source. It is hypothesized herein that this was due to deficiency
of omega-6 derived prostaglandins, which aid ovulation. The same
phenomenon was observed when the subject was put on Advil, which
blocks cyclooxygenase activity and therefore the prostaglandin
synthesis.
[0132] Dietary fatty acids are intricately linked with reproduction
from menstruation, to fertilization, to gestation-related
complications such as diabetes, to development of the fetus, to
pre-term delivery, to post-natal health of the mother and the
child.
Example 21
Case Studies on Aging, Tissue Repair
[0133] In host subjects, symptoms of aging was modulated by
balancing and optimizing omega-6 and omega-3 fatty acids including
muscle mass restoration, stabilizing sleep, increasing mental
sharpness, increasing energy and vigor, improved skin, reduction in
hair loss, improving bowel function, improving libido and sexual
function, and weight management. The management of frequent
urination with the ideal balance of omega-6 and omega-3 was also
observed. It is hypothesized that this is due to combined effect of
management of omega-6 and omega-3 related eicosanoids and their
effect on physiological functions, and due to the sex-hormone-like
effect of these lipids, and due to their effect on the optimization
of sex hormone production.
[0134] The present disclosure also provides compositions and
methods for tissue repair and/or regeneration by induction and
maintenance of endogenous stem cell proliferation and/or
differentiation including by providing the environment for the stem
cells to proliferation and/or differentiate. The fibroblast is a
type of cell that synthesizes the extra-cellular matrix and
collagen, the structural framework for animal tissues. Proper
fibroblast function is essential for optimal tissue repair and
regeneration. Polyunsaturated fatty acids and sterols create a
favorable fibroblast plasma membrane environment, and are believed
to play a role in electrochemical gradient across the bilayer-lipid
membrane. Schroeder F, Kier A B, Sweet W D. Role of polyunsaturated
fatty acids and lipid peroxidation in LM fibroblast plasma membrane
transbilayer structure. Arch Biochem Biophys. 1990 January;
276(1):55-64. Haines T H. Do sterols reduce proton and sodium leaks
through lipid bilayers? Prog Lipid Res. 2001 July; 40(4):299-324.
Intestinal cells and bone marrow cells offer examples of adult stem
cells for their abundance and their role in the continuous,
lifelong, physiological replenishment of circulating cells.
Example 22
A Case Study on Pulmonary Disorders
[0135] In a host subject, an increase of omega-6 or a decrease of
omega-3 was associated with breathing difficulty, nasal congestion,
ear ache, sneezing, and excess mucus. But within the optimal ranges
of omega-6 and omega-3, it was self-adjusting over a period of
time. A low-fat diet, primarily monounsaturated fats, a total
essential fatty acid (EFA) supplement of 1 gram, and a fish oil
supplement caused dyspnea in the host subject. The dyspnea
disappeared when supplemented with 10-11 grams of omega-6. It is
concluded that the EFA supplement was not adequately producing the
required leukotrienes. Omega-6 and omega-3-derived leukotrienes are
very important agents in lung function. They help bring the needed
cells to the tissue, and they increase vascular permeability. In
excess they can cause airflow obstruction, increased secretion and
accumulation of mucus, bronchial constriction, and inflammation.
The self-adjustment indicates that sudden and wide changes may
upset the immune system. Further studies may find a link with
susceptibility to common colds and influenza with sudden and wide
changes in omega-6 and omega-3.
Example 23
A Case Study on Ophthalmologic Disorders
[0136] In a host subject, dry eye and pressure-like ache in the eye
was observed upon reduction of omega-3 and an increase of omega-6.
When levels of omega-6 and omega-3 were kept within suitable ranges
by demographic type, the symptoms disappeared over time. It was
also observed that drusen, excessive eye mucus that often gathers
in the corners of the eyes, could be gotten rid of with proper
omega-6 and omega-3 balance. However, when omega-6 or omega-3 were
excessively increased the dry eye syndrome persisted. Excessive
omega-3 also resulted in very thin blood-thromboxanes action
reduction--and therefore caused blood-shot eyes.
[0137] Docosahexaenoic acid (omega-3) is an important component of
retinal photoreceptors and brain synaptic membranes, and
arachidonic acid (omega-6) is an important component of vascular
endothelial cells. Moreover, since omega-6 also has a role in
vascular blood pressure, both omega-6 and omega-3 are critical to
optic health. Although omega-3, and formulations of vitamins C, E,
beta-carotene, and zinc have been shown to be preventative in
progression of age-related macular degeneration (AMD); increased
intakes of lutein/xeaxanthin and omega-3 fatty acids are associated
with progression of AMD, whereas lower intakes lutein/xeaxanthin
and omega-3 are associated with greater optic health; suggesting
the role of phytochemicals, and the importance of dosage. Robman L,
Vu H, Hodge A, Tikellis G, Dimitrov P, McCarty C, Guymer R. Dietary
lutein, zeaxanthin, and fats and the progression of age-related
macular degeneration. Can J. Opthalmol. 2007 October;
42(5):720-6.
Example 24
Case Studies on Dermatological Disorders
[0138] Host subjects demonstrated large amounts of omega-3 in the
diet increased the size of the skin pores, whereas large amounts of
omega-6 in the diet made skin dry. Balancing the two gave the best
results. Fine lines may be reduced using the correct balance.
Omega-6 reduction, at times, may be associated with the appearance
of a rash around the neck area. It is hypothesized that a sudden
increase in cytokine activity from an increase in omega-6 produced
the skin rash. Brittle nails and foot corns and calluses disappear
with the proper balance of fatty acids. Sloughing of skin, as in
dead cells coming to the surface after omega-3 reduction, was also
observed.
[0139] Skin displays highly active metabolism of polyunsaturated
fatty acids. Deficiency of dietary omega-6, linoleic acid results
in scaly dermatoses and disruption of the skin barrier system,
Linoleic acid intake combined with high intakes of vitamin C are
associated with better skin-aging appearance. Dietary hempseed oil
has been shown to cause significant changes in plasma fatty acid
profiles and improved clinical symptoms of atopic dermatitis, which
may be due to the abundant supply of both omega-6 and omega-3 fats
in hempseed oil. Ziboh V A. Prostaglandins, leukotrienes, and
hydroxy fatty acids in epidermis. Semin Dermatol. 1992 June;
11(2):114-20. Ziboh V A, Cho Y, Mani I, Xi S. Biological
significance of essential fatty
acids/prostanoids/lipoxygenase-derived monohydroxy fatty acids in
the skin. Arch Pharm Res. 2002 December; 25(6):747-58. Cosgrove M
C, Franco O H, Granger S P, Murray P G, Mayes A E. Dietary nutrient
intakes and skin-aging appearance among middle-aged American women.
Am J Clin Nutr. 2008 August; 88(2):480.
Example 25
Case Studies on Sleep Disorders
[0140] It was observed that use of optimized levels of omega-6 and
omega-3 by demographic type, more restful sleep may be achieved,
and normalization of sleep and wake hours in host subjects. In
fact, a more restful sleep with a sleep time reduction to 7 hours
from 8 in one host subject, over time was observed. Restless leg
syndrome may also be relieved in host subjects. Each time omega-6
and omega-3 amounts were changed the host went through an
adjustment period. Omega-3 was more sleep inducing and omega-6 was
more awakening, to the point of causing temporary insomnia. It is
hypothesized this is because of the effect of omega-6 and omega-3
fatty acids on thyroid function and the effect of thyroid function
on sleep, among other mechanisms.
[0141] Omega-6 metabolite PGD2 is believed to be a strong
sleep-inducing agent, with a strong rebound of wakefulness reaching
insomnia. In other studies omega-3-deficient diet has been shown to
lessen the pineal melatonin rhythm, weaken the endogenous
functioning of the circadian clock, and to play a role in nocturnal
sleep disturbances. Among other fatty acids, palmitoleic and oleic
acid have been shown to be important for sleep disorders, perhaps
due to their function as precursors of the sleep inducing
oleamide.
Example 26
A Case Study on Dental Diseases
[0142] In a vegetarian host subject, less dental sensitivity,
reversal of gum receding, brightening of tooth enamel, and
lessening of dental spots and plaque may be exhibited when omega-3
was reduced from 2 grams to 1.2 grams while holding omega-6
constant at 11 grams. Lipid compositions comprising nuts and oils
were the source of omega-6 and omega-3 fatty acids. There was an
adjustment period of 3-6 weeks, when the symptoms got worse in the
host subjects before getting better. Longer-term intervention
studies should be able to test a hypothesis by studying tooth loss
during the intervention period. Bioactivity of lipids may explain
the linkage between periodontitis/tooth loss and coronary heart
disease.
Example 27
Case Studies on Immunity, Autoimmune and Infectious and
Inflammatory Diseases
[0143] In a vegetarian host subject, a 48-year old menopausal
woman, on 11 g of LA and 1.8 g of ALA, from oils and nuts, spinal
burning sensation, heat in the body, skin and feet, and delayed
wound healing were observed. The subject also developed vaginal
yeast infection. Symptoms disappeared upon reducing ALA to 1.2 g
after an initial adjustment period. It is hypothesized that omega-6
and omega-3 imbalance leads to inflammation, compromised immunity,
and infection. It is further suspected that both omega-6 and
omega-3 are anti-inflammatory in small doses and inflammatory in
large doses.
[0144] It is understood that the total percent by weight of any
combination of components does not exceed 100%. It is also
understood that if a component is present in a composition, then
the component is present in a non-zero amount (for example, more
than about 0.00000001) mg or percent by weight of total
weight).
[0145] The amounts and ratios of various nuts, seeds, lipids, and
oil, to name a few, of the present embodiments were discovered to
be beneficial, including by links to benefits for various diseases
and conditions, as set forth above, empirically by outcome focused
experimentation. The above recited examples, case studies, links
with particular medical conditions, and the like are not meant to
limit the present disclosure, but merely to explain the disclosure
by way of example.
[0146] While some embodiments of the present disclosure have been
shown and described herein, it will be obvious to those skilled in
the art that such embodiments are provided by way of example only.
Numerous variations, changes, and substitutions will now occur to
those skilled in the art without departing from the disclosure. It
should be understood that various alternatives to the embodiments
of the disclosure described herein may be employed in practicing
the disclosure. It is intended that the following claims define the
scope of the disclosure and that methods and structures within the
scope of these claims and their equivalents be covered thereby.
* * * * *
References