U.S. patent application number 15/353932 was filed with the patent office on 2017-03-09 for compositions containing as the active ingredient components from salvia sclarea seed.
The applicant listed for this patent is THE STATE OF ISRAEL, MINISTRY OF AGRICULTURAL & RURAL DEVELOPMENT, AGRICULTURAL RESEARCH. Invention is credited to David CHAIMOVITSH, Nativ DUDAI, Eli PUTIEVSKY, Diah SAADI, Dan SCHAFFERMAN, Zohara YANIV BACHARACH.
Application Number | 20170065546 15/353932 |
Document ID | / |
Family ID | 32697142 |
Filed Date | 2017-03-09 |
United States Patent
Application |
20170065546 |
Kind Code |
A1 |
DUDAI; Nativ ; et
al. |
March 9, 2017 |
COMPOSITIONS CONTAINING AS THE ACTIVE INGREDIENT COMPONENTS FROM
SALVIA SCLAREA SEED
Abstract
The present invention concerns a food supplement comprising
Salvia sclarea seeds, or flour, oil or pulp or extracts obtained
from the seeds as well as finished food products comprising the
food supplement. The present invention further concerns a
nutraceutical or cosmetic preparation comprising as an active
ingredient Salvia sclarea seeds, or flour, oil or pulp or extracts
obtained from the seeds.
Inventors: |
DUDAI; Nativ; (Kfar
Yeheskel, IL) ; YANIV BACHARACH; Zohara; (Tel Aviv,
IL) ; PUTIEVSKY; Eli; (Tivon, IL) ; SAADI;
Diah; (Bosmat Tivon, IL) ; SCHAFFERMAN; Dan;
(Ramat Gan, IL) ; CHAIMOVITSH; David; (Gan Ner,
IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
THE STATE OF ISRAEL, MINISTRY OF AGRICULTURAL & RURAL
DEVELOPMENT, AGRICULTURAL RESEARCH |
Rishon Lezion |
|
IL |
|
|
Family ID: |
32697142 |
Appl. No.: |
15/353932 |
Filed: |
November 17, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13946402 |
Jul 19, 2013 |
9532964 |
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15353932 |
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10570810 |
Aug 25, 2006 |
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PCT/IL2004/000804 |
Sep 7, 2004 |
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13946402 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A23D 7/0053 20130101;
C11B 1/06 20130101; A23K 40/25 20160501; A23K 20/158 20160501; A23K
40/20 20160501; A23K 50/80 20160501; A23L 2/39 20130101; A23D 7/003
20130101; A23K 20/10 20160501; A61Q 19/00 20130101; A21D 2/36
20130101; A23D 7/001 20130101; A61K 2236/30 20130101; Y02A 40/818
20180101; A23D 9/00 20130101; A23L 33/115 20160801; A23L 17/30
20160801; A61K 31/202 20130101; A61P 17/00 20180101; A61P 35/00
20180101; A23K 50/75 20160501; A23L 7/135 20160801; A23L 29/206
20160801; A23L 33/105 20160801; A23L 23/00 20160801; A23L 7/198
20160801; C11B 9/025 20130101; A23L 7/109 20160801; A61P 3/10
20180101; A23D 7/0056 20130101; A23L 17/35 20160801; A61P 19/02
20180101; C11B 9/02 20130101; A23L 27/60 20160801; A23V 2002/00
20130101; A61K 36/537 20130101; A61P 29/00 20180101; A61P 25/18
20180101; A61Q 19/08 20130101; A61P 25/24 20180101; A21D 2/266
20130101; A61K 2236/15 20130101; A61P 17/06 20180101; A61K 8/9789
20170801; A61P 9/04 20180101; A61P 43/00 20180101; A61P 9/10
20180101; A23L 7/126 20160801 |
International
Class: |
A61K 31/202 20060101
A61K031/202; A61Q 19/00 20060101 A61Q019/00; A61K 8/36 20060101
A61K008/36; A61K 36/537 20060101 A61K036/537; C11B 1/06 20060101
C11B001/06; C11B 9/02 20060101 C11B009/02; A21D 2/26 20060101
A21D002/26; A21D 2/36 20060101 A21D002/36; A23D 7/00 20060101
A23D007/00; A23D 7/005 20060101 A23D007/005; A23D 9/00 20060101
A23D009/00; A23K 20/158 20060101 A23K020/158; A23K 50/75 20060101
A23K050/75; A23K 50/80 20060101 A23K050/80; A23L 7/109 20060101
A23L007/109; A23L 7/126 20060101 A23L007/126; A23L 7/10 20060101
A23L007/10; A23L 17/30 20060101 A23L017/30; A23L 23/00 20060101
A23L023/00; A23L 27/60 20060101 A23L027/60; A23L 29/206 20060101
A23L029/206; A23L 33/105 20060101 A23L033/105; A23L 33/115 20060101
A23L033/115; A61Q 19/08 20060101 A61Q019/08 |
Foreign Application Data
Date |
Code |
Application Number |
Sep 7, 2003 |
IL |
157785 |
Claims
1-21. (canceled)
22. A method of preventing wrinkling of skin or ensuring skin
health in a subject, comprising: topically applying to the subject
a therapeutically effective amount of a cosmetic composition
comprising Salvia sclarea seed oil.
23. A therapeutic method of increasing the level of omega-3 fatty
acid in a subject, comprising: administering to the subject a
therapeutically effective amount of a product selected from the
group consisting of Salvia sclarea seed, Salvia sclarea seed oil,
and Salvia sclarea seed crushed or milled to form a flour or
powder.
24. A therapeutic method of treating a subject suffering from a
disease or condition which is known scientifically, or is
discovered empirically, to benefit from an increase in the level of
omega-3 fatty acid, comprising: orally administering to the subject
an effective amount of a product selected from the group consisting
of Salvia sclarea seed, Salvia sclarea seed oil, and Salvia sclarea
seed crushed or milled to form a flour or powder.
25. In a method for relieving the symptoms of psoriasis in a
subject, comprising topically administering to the affected area of
the subject an effective amount of a composition comprising omega-3
fatty acids, the improvement wherein said composition comprises
Salvia sclarea seed oil.
26. A method in accordance with claim 24, wherein said disease or
condition is coronary artery disease.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to food supplements and
nutraceutical compositions for raising omega-3 levels in a
subject.
BACKGROUND OF THE INVENTION
[0002] Current research in nutritional medicine indicates that the
omega-3 fatty acids are essential components of the human diet.
According to studies published in the British scientific journal
Lancet, the observed low incidence of arteriosclerosis (fatty
plaques development on the inner walls of the arteries which
obstructs the blood flow), including coronary artery disease,
chronic inflammatory disease and diabetes in Greenland Eskimos has
been attributed to their traditional ethnic diet, consisting
largely of meat from whale, seals, sea birds and fish. This diet is
rich in fat and protein and low in carbohydrates, but it is
extremely high in omega-3 polyunsaturated fatty acids, and
especially rich in two omega-3 fatty acids: C22:6 (DHA) and C20:5
(EPA).
[0003] The most important omega-3 fatty acids are eicosapentaenoic
acid (EPA), docosahexaenoic acid (DHA) and .alpha.-linolenic acid
(ALA).
[0004] EPA is a direct source of an important substance called
prostaglandin E3, which is directly responsible for making blood
platelets less sticky, thus leading to an easier flow of blood. EPA
is, therefore, involved in processes that inhibit blood clots whose
presence threaten to obstruct the circulation; this mode of action
is particularly important in the small capillaries of the
heart.
[0005] DHA (docosahexaenoic acid) is an omega-3 fatty acid of
almost equal importance to EPA. DHA comprises a significant amount
of the tissues that make up the human brain as well as a large part
of the retina of the eye.
[0006] Some of the most dramatic effects of increased intake of
omega-3 fatty acids are the lowering of high blood pressure,
reduction of serum triglyceride levels, and an increase in clotting
time, all positive steps in the prevention of heart and blood
vessel diseases. These beneficial effects of omega-3 fatty acids
have been noted in both clinical trials and epidemiological
studies. Omega-3 fatty acids were found to be extremely useful
natural substances powerful enough to normalize the high
cholesterol and triglyceride levels that are so extensive in modern
populations.
[0007] Omega-3 fatty acids have also been shown to slow down or
prevent cancerous tumor growth, prevent blood vessels from closing
following vascular surgery, improve inflammatory diseases such as
rheumatoid arthritis and relieve symptoms of psoriasis. In
addition, omega-3 fatty acids are essential for proper vision and
brain development in newborns.
[0008] The average western diet is low in fresh fish and sea food
containing EPA and DHA. On the other hand, it is high in refined
carbohydrates and saturated fats. This kind of diet can lead to a
serious deficiency in the raw materials necessary for proper
platelet function in the blood stream.
[0009] Linolenic acid is essential for ensuring healthy skin
condition. Moreover, oils containing large amounts of omega-3 fatty
acids were shown to be effective in preventing skin wrinkles. The
ingestion of these oils markedly lowers the cholesterol content in
the blood. .alpha.-Linolenic acid is a fatty acid found in some
plants and can be converted by the body to EPA and DHA. Plant
sources of .alpha.-linolenic acid include walnuts and walnut oil,
flaxseed, rapeseed (used to make canola oil), soybeans, spinach,
mustard greens and purslane.
[0010] .alpha.-Linolenic acid is produced in high quantities in
several plants, mainly hemp (up to 23% .alpha.-linolenic acid is
pressed from hempseed) and flax (50%). These oils normally have an
"off" flavor and are seldom used as edible oils due to their bad
taste and smell. Conventional food oils, such as rapeseed (canola)
and soybean contain only small amounts of linolenic acid (11% and
7% respectively).
[0011] Researchers believe that a 1:1 ratio of omega-6 to omega-3
(omega-6 is found primarily in vegetable oils like corn, safflower
or sunflower) may be important in preventing heart disease. It
seems that omega-3's and omega-6's continually compete for control
of important biochemical reactions in the body. When the portion of
omega-6 is higher than that of omega-3, it can lead to an
overproduction of hormone-like substances called prostaglandins and
leukotrienes. Large amounts of these hormone-like substances can
disrupt the immune system, initiate the build-up of plaque
formations on artery walls, form blood clots and trigger
dangerously irregular heart rhythms.
[0012] Currently, the ratio in the American diet is about 10
omega-6 to 1 omega-3, a ratio, some experts say, which is a
dangerous oversupply of omega-6 fatty acids.
[0013] Dietary fish oils containing omega-3 fatty acids are
increasingly recommended for their antithrombic and hypolipidemic
(lowering blood lipid) effects (Phillipson, Rothrock, Connor,
Harris and Illingworthm, New England J. Med., 312:1210-16, 1985).
Additional benefits of these oils are improvement of immunological
function and fighting allergies (Leaf and Weber, New England J.
Med, 318:549-557, 1988).
[0014] Omega-3 fatty acids from vegetable oils could provide all
the above health benefits without any of the disadvantages of oil
from animal source.
[0015] During ingestion of vegetable oil there is no uptake of
cholesterol. Fish oils are a primary source of vitamins A and D.
Most marine oils may supply potentially toxic amounts of vitamins A
and D, by supplying a sufficient amount of EPA and DHA factors.
Also, many vegetal omega-3 oils have a clean flavor have a good
taste, at least as compared to bad tasting fish oils. Fish oils are
usually contained in preservative-free gelatin capsules for
convenience due to their bad taste and smell.
[0016] Aromatic (essential) oil derived from flowers of Salvia
sclarea has been used up to date mainly as a perfume; this usage
was known from the time of ancient Rome. Other secondary uses for
this aromatic oil have been in the tobacco industry, and in herbal
remedies to fight infection, and to regulate the digestive system.
The natural habitat of the plant is in Syria, Italy and Southern
France; and its growth requirements in terms of soil content are
not particular. Currently, the former Soviet Union, North Africa,
and Hungary are the largest producers of this oil, and prices range
from $60-90 per liter of oil. The plant can withstand heat, and is
found on mountainous terrain, where rainfall is not lower than 400
mm annually. The floral parts alone are used to produce the oil;
inclusion of leaves will degrade the oil quality. Typically a
single harvest of floral parts is performed. If harvest is
performed prematurely, the oil will contain a large percentage of
linoleic acetate, which lowers the quality of the oil.
[0017] No previous use has been made of the seeds of Salvia
sclarea; previous uses, mainly as a perfume or essential oils, were
from plant material derived from the flower.
[0018] WO 99/62356 concerns enhanced food for humans which has
significantly higher omega-3 content by the use of oil obtained
from Salvia hispanica seed. Salvia hispanica (Chia) is a summer
annual belonging to the Labiate family. It originates in mountain
regions extending from west central Mexico to northern Guatemala.
Due to its endemic growth restriction to mountain regions of
central and southern America and thus its natural habitat is very
specific and growth requirements very particular, making seed grown
from the plant not economical, the plants are not widespread and
have not acquired wide commercial acceptance as a food source.
[0019] It should be emphasized that the presence of ALA omega-3
fatty acid in oil produced from the seeds of one or another plant
does not in itself suffice to indicate that the plant will be a
good and effective source for that fatty acid. The range of
different parameters, such as commercial cultivability, climatic
conditions, regulatory provisions, profile of the fatty acids,
percentage of fatty acids, ratio of omega-3 to omega-6, stability,
flavor, fragrance, color, acidity, moisture, toxins, allergens,
presence of vitamins and antioxidants in the oil, as well as many
other parameters, determine whether oil from a certain plant will
be a good and effective source for ALA omega-3 fatty acid.
Sometimes, one parameter alone, such as aftertaste (e.g. in flax
oil or Matthiola oil), or overoxidation (in flax or Salvia
hispanica oil), suffices to prevent use of the oil as an effective
and stable source for ALA omega-3 fatty acid in a nutritional
supplement. Obviously, such a plant source cannot be designated as
a good and effective source, when a large number of drawbacks come
together in terms of the parameters listed above.
SUMMARY OF THE INVENTION
[0020] It has now been discovered, surprisingly, that it is
possible to produce from the seeds of the plant called clary sage,
whose Latin name is Salvia sclarea, a plant oil which is rich in
fatty acids of nutritional value, among them omega-3 fatty acids,
and at the same time has no unpleasant taste or odor, that is free
of toxins and does not oxidize easily upon contact with air. It is
surprising that the oil from the seeds of Salvia sclarea have no
sharp or unpleasant taste or odor because Salvia sclarea is known
as a plant with a sharp odor, to the extent that it is used in
industry in the preparation of essential oils, i.e., aromatic
volatile oils which do not contain fatty acids and which are used
in the fragrance and flavor industry and mainly in the perfume
industry. One would have expected oil that is produced from seeds
of this plant also to have a sharp taste and odor, and accordingly
be unsuitable for incorporation into foods. It is further noted
that the genus Salvia includes species that are known to contain
different percentages of toxins (such as thujone), and therefore,
in general, the health authorities place obstacles in the way of
the approval of food supplements derived from Salvia, a fact which
was likely to dissuade researchers from studying Salvia plants for
the production of plant-based food supplements.
[0021] Furthermore, the discovery of the unique combination between
the fatty acids in the plant (in addition to omega-3 fatty acid,
the seeds of this plant are especially rich in oleic acid and other
ingredients, and the oil produced contains an optimal ratio between
omega-3 and omega-6) and the absence of toxins, including allergens
or harmful substances, indicated that this plant could be very
advantageously used for the production of a plant oil that could
serve as a food supplement. In addition, it was discovered that oil
produced from the seeds of Salvia sclarea is, surprisingly, more
stable than would have been expected of an oil containing such a
large quantity of ALA, and the advantageousness of this trait for
industrial use in the food industry is apparent.
[0022] The present invention thus embodies numerous advantages,
inter alia, in that it enables the production of a nutritional
supplement containing omega-3 fatty acid which has a neutral
fragrance and taste; is free of toxins, allergens or harmful
substances such as heavy metals; tends to oxidize less; and
producible in an agrotechnically efficient manner. Moreover, the
chemical composition of a nutritional supplement according to the
invention embodies a unique combination of fatty acids, minerals
and other components, including oleic acid, calcium, fibers and
amino acids, the composition and quantities of which could not have
been foreseen, as also the optimal ratio between omega-3 and
omega-6.
[0023] Seeds of selected lines of Salvia sclarea (Labiate) (also
known as "clary sage") have an average oil content of 25-30%.
[0024] The inventors now disclose that the seed oil of this plant
is a rich source of omega-3 .alpha.-linolenic acid (about 55%). The
other components of this oil are two important fatty acids: oleic
acid (C18:1), which is present in extremely high levels, and
linoleic acid (C18:2). Both acids are unsaturated fatty acids and
are essential in the human diet.
[0025] The present invention hereby discloses whole seeds, or oil,
flour/powder, or pulp obtained from Salvia sclarea seeds, having
all the health benefits of fish oil but none of its drawbacks
(notably its bad taste, distinctive smell and quick rancidity). The
oil or flour/powder has the additional above-mentioned benefits
over other vegetable oils, and can be used for dietary supplements,
as an active ingredient in pharmaceutical and cosmetic
compositions, and for industrial uses.
[0026] Another important application of this vegetable oil is its
use as a drying oil for painting and lubrication, due to its high
content of polyunsaturated fatty acids, namely linolenic acid. Up
to date, vegetative drying oil has been obtained from crops such as
flax seeds and Tong trees. These crops do not lend themselves to
mechanical harvesting and cleaning. Salvia sclarea seed oil is
useful for industry, and is relatively easy to obtain.
[0027] The prior art discloses (WO 99/62356) oil, rich in omega-3,
obtained from Salvia hispanica, which is an endemic plant
restricted in its growth to the high mountain area of Central and
South America. The present invention is based on the surprising
finding that seeds obtained from another variant of Salvia, i.e.
being Salvia sclarea, have better nutritional value than oil, or
crushed seed, obtained from Salvia hispanica as will be shown in
the detailed description part of the invention and have other
significant properties that are superior thereto, including, taste,
color and oxidative stability (i.e., long shelf life), in addition
to the aforementioned ease of cultivation and harvesting.
[0028] The difference between Salvia sclarea and Salvia hispanica
is expressed in additional aspects, such as the fact that the
latter does not contain the combination of a high concentration of
ALA together with a high concentration of oleic acid. Oleic acid
(omega-9) is a monounsaturated fatty acid known to help in the
prevention of coronary disease. Olive oil, for example, contains
55% to 85% of oleic acid, which is known to reduce the risk of
arteriosclerosis, coronary disease and stroke. The oleic acid
content in Salvia sclarea is almost four times higher than in
Salvia hispanica. The ratio between omega-3 and omega-6 is greater
in Salvia sclarea, as can be seen in Table 2, below. Furthermore,
it is known that oil produced from Salvia sclarea contains
sclareol, which is not found in Salvia hispanica. Likewise, the
outstanding stability of the oil produced from the sclarea species
does not exist in the Salvia hispanica species.
[0029] Furthermore, the present invention is based on the
realization that not only the oil or crushed flour/powder of Salvia
sclarea has higher nutritional value than the oil of Salvia
hispanica, but also the growth of the plant of the Salvia sclarea
variety, as compared to the Salvia hispanica variety is more
economical. The Saliva sclarea plants can grow in any Mediterranean
climate such as in the Middle East, in Europe (including Southern
European countries such as Italy, Spain and Southern France as well
as Northern and Eastern European countries such as Finland and
Russia), North Africa, California and Australia; and its growth
requirements in terms of soil content are not particular. The plant
can withstand both heat and cold (even snow), and is found on
mountainous terrain, where rainfall is even lower than 400 mm
annually.
[0030] Beyond this, the seeds of Salvia sclarea possess numerous
advantages compared to Salvia hispanica. Thus, for example: [0031]
The seeds of Salvia hispanica are generally likely to be dark, and
thus unsuited to the color and texture of food products and
supplements, in contrast to the seeds of Salvia sclarea, which have
a light and uniform color. It has long been known that a dark color
in the field of nutritional supplements is an undesirable trait.
Sometimes, a dark color necessitates adding color lightening
additives which could affect the traits of the active ingredient in
the nutritional supplement. Therefore, a nutritional supplement
whose original color is light possesses clear advantages. [0032]
The size and uniformity of the Salvia sclarea plants and their
botanical traits enable more efficient cultivation. [0033] Salvia
sclarea is a perennial plant, whereas Salvia hispanica is an annual
plant. Therefore, Salvia sclarea is more cost efficient (cheaper)
to grow than Salvia hispanica, which suffers from an additional
drawback, noted above, namely, the absence of phenotypic uniformity
among individuals from the same species, e.g. variance in the size
of the plants or in the time of ripening makes it difficult to
harvest them by industrial means (combine harvesters).
[0034] The present invention is further based on the surprising
finding that from among several species of different Salvia, the
specific Salvia sclarea of the present invention was found to have
an extremely high nutritional value and very long shelf life
without rancidity.
[0035] Thus, the present invention concerns a composition for use
as a food supplement comprising, as an active ingredient, a
composition of matter selected from:
[0036] a. Salvia sclarea seed;
[0037] b. Salvia sclarea seed oil in an essentially pure form;
[0038] c. extracts of Salvia sclarea seed;
[0039] d. Salvia sclarea seed crushed or milled to form a flour or
powder; and
[0040] e. Salvia sclarea seed pulp.
[0041] The term "composition of matter" refers to several
components (fatty acids, proteins, minerals, vitamins, dietary
fibers) present as a mixture with specific ratios between the
components.
[0042] The term "Salvia sclarea seed" refers to the whole seed,
essentially in an unprocessed form as separated from the full
plant.
[0043] The term "Salvia sclarea seed oil in an essentially pure
form" refers to oil obtained from the seed, which is essentially
free from other components. The oil may be obtained by various
manners known to separate oil from plant-seeds without damaging
their nutritional value.
[0044] Examples of manners for separating the oil include: [0045]
1) "cold press" achieved by crushing and pressing the seed,
centrifugation of the pressed seed for collection of the oily
fraction present in the supernatant, and optionally also
purification by various means known in the art such as by using
filters, collecting sediments, etc.; [0046] 2) By use of volatile
hydrophobic solvents which initially dissolve the oil, and then are
evaporated by application of heat and/or vacuum. [0047] 3) By use
of liquid CO.sub.2 or liquid nitrogen in extremely cold temperature
("super-critical extraction").
[0048] The term "Salvia sclarea seed, crushed or milled to form
flour or powder" refers to crushing or milling of the seed to fine
particles by any mechanical milling means known in the art in order
to break the seed into smaller fragments such as crumbs of flour or
particles of powder, and in those flour/powder forms, most of the
nutrients are more available to the subject than in the whole
seed.
[0049] The term "Salvia sclarea seed pulp" refers in fact also to
"defatted Salvia sclarea seed flour". These two alternative terms
refer to the seed after the oily fraction has been extracted there
from, which pulp is especially rich in dietary fibers, minerals,
vitamins and proteins and poor in fatty acids and calories.
[0050] The term "extract of Salvia sclarea seed" refers to any
compound that is extracted from the seed by using aqueous or
alcoholic, or other organic extracts. Typically, where the
extracting liquid is water, mostly to fibers (dietary fibers).
[0051] By a preferred embodiment of the present invention, the food
supplement consists essentially of:
[0052] a. Salvia sclarea seed;
[0053] b. Salvia sclarea seed oil in an essentially pure form;
[0054] c. extract of Salvia sclarea seed;
[0055] d. Salvia sclarea seed crushed or milled to form a flour or
powder; and
[0056] e. Salvia sclarea seed pulp.
[0057] Preferably, in accordance with a preferred embodiment of the
invention, the composition of matter is Salvia sclarea oil or
Salvia sclarea flour or powder.
[0058] By a more preferred embodiment of the invention the food
supplement consists of:
[0059] a. Salvia sclarea seed;
[0060] b. Salvia sclarea seed oil in an essentially pure form;
[0061] c. extract of Salvia sclarea seed;
[0062] d. Salvia sclarea seed crushed or milled to form a flour or
powder; and
[0063] e. Salvia sclarea seed pulp.
[0064] By one embodiment, the food supplement further comprises a
"carrier" suitable for consumption in food products. The carrier is
chosen as a carrier known in the art for the specific type of
composition of matter of the invention. For example, where the
composition of matter of the invention is oil, the carrier may be
other types of vegetable oils such as olive oil, rapeseed (canola)
oil, corn oil, soy oil, wheat germ oil, coconut oil, peanut oil,
sesame oil, palm oil, almond oil, nut, such as walnut, oil, etc.
Where the composition of matter of the invention is powder or flour
the "carrier" may be other types of flour/powder such as wheat,
barley, corn, soy flour, oat flour, rice flour, tapioca, or rye
flour.
[0065] By another possibility, the food supplement contains only
one of the ingredients (a-e) above without any "carrier".
[0066] The present invention further concerns the use of an agent
selected from
[0067] a. Salvia sclarea seed;
[0068] b. Salvia sclarea seed oil in an essentially pure form;
[0069] c. extracts of Salvia sclarea seed;
[0070] d. Salvia sclarea seed crushed or milled to form a flour or
powder; and
[0071] e. Salvia sclarea seed pulp for the preparation of a food
supplement.
[0072] The food supplement above may be used for human or non-human
consumption, preferably in order to increase the level of at least
one omega-3 fatty acid in the subject. The non-human animal may be
a farm animal, such as cattle (cow, goat, and sheep) or poultry
(hens, ducks, turkeys), as well as fish grown in fish ponds, such
as carp, bass, tilapia, trout, and pond-raised salmon.
[0073] The food supplement of the present invention is expected to
raise the level of at least one omega-3 fatty acid in the meat of
the non-human animal (cow, sheep, hens, fish), as well as to raise
the level of at least one omega-3 fatty acid in the products of the
animals, such as milk and eggs.
[0074] Thus, the present invention concerns a method for increasing
at least one omega-3 fatty acid level in a subject, the method
comprising administering to the subject an effective amount of the
food supplement of the present invention. The subject may be as
defined above and may be a human or non-human animal.
[0075] The term "effective amount" is an amount that increases the
level of at least one omega-3 fatty acid in a statistically
significant manner as compared to a control subject not fed with
the food supplement of the present invention.
[0076] The increase in the level of omega-3 fatty acid in the
animal may be adjusted in accordance with the type of subject and
the desired level, but typically, for example, in egg yolks is an
increase of 2- to 10-fold, preferably an increase of more than
4-fold, more preferably an increase of more than 6-fold.
[0077] By another aspect, the present invention concerns a method
for increasing the level of at least one omega-3 fatty acid in egg
yolks or in the meat of hens, the method comprising: administering
to the hens an effective amount the food supplement of the present
invention.
[0078] The term "effective amount" is as defined above.
[0079] The present invention further concerns a nutraceutical
composition comprising a nutraceutically acceptable carrier and, as
an active ingredient, a composition of matter selected from:
[0080] a. Salvia sclarea seed;
[0081] b. Salvia sclarea seed oil in an essentially pure form;
[0082] c. extracts of Salvia sclarea seed;
[0083] d. Salvia sclarea seed crushed or milled to form a flour or
powder; and
[0084] e. Salvia sclarea seed pulp Salvia sclarea seed oil in an
essentially pure form.
Preferably, the Salvia seed oil is prepared by as disclosed above.
More preferably, the nutraceutical composition consists essentially
of a composition of matter selected from:
[0085] a. Salvia sclarea seed;
[0086] b. Salvia sclarea seed oil in an essentially pure form;
[0087] c. extracts of Salvia sclarea seed;
[0088] d. Salvia sclarea seed crushed or milled to form a flour or
powder; and
[0089] e. Salvia sclarea seed pulp Salvia sclarea seed oil in an
essentially pure form.
[0090] The term "nutraceutical composition" refers to any substance
that is a food or a part of a food and provides medical or health
benefits, including the prevention and treatment of disease or
disorder.
[0091] The present invention further concerns a nutraceutical
composition as defined above for the treatment of a disease or a
disorder wherein a therapeutically beneficial effect may be evident
by increasing the level of at least one omega-3 fatty acid.
[0092] The term "treatment . . . therapeutically beneficial effect"
may refer to at least one of the following: decrease in at least
one undesirable effect of the disease; slowing the deterioration
caused by the disease; increase in the disease-free time period; or
prevention of the disease altogether.
[0093] Typically, the disease or disorder is selected from:
arthrosclerosis, coronary artery disease, chronic inflammatory
disease such as rheumatoid arthritis and IBD, diabetes, cancer,
prevention of blood vessels from closing after vascular surgery,
relieving symptoms of psoriasis, skin wrinkles and depression and
mood disorders. The disease may be any disease or condition which
is known scientifically, or is discovered empirically, to benefit
from the increase in the level of at least one omega-3 fatty acid
in the subject.
[0094] The nutraceutical composition is typically taken orally, for
example in the form of gel-capsules containing the oil, liquid
formulation containing the oil, tablets containing the flour/powder
as known in the art for preparing such compositions, but for
several indications, such as psoriasis, and other dermal conditions
(wrinkles, dry skin), the oil containing formulations (gel-caps,
oil) may also be topically applied.
[0095] The present invention further concerns a cosmetic
composition comprising a cosmetically acceptable carrier and, as an
active ingredient, Salvia sclarea seed oil in an essentially pure
form. Typically the cosmetic composition is for prevention of
wrinkles of the skin and/or ensuring skin health.
[0096] The term "at least one omega-3 fatty acid" refers to any
unsaturated fatty acid with its first double bond at the third
carbon atom from the methyl-end. These fatty acids may be such as
essential fatty acid, .alpha.-linoleic acid (ALA) as well as non
essential fatty acids such as docosahexaenoic acid (DHA) and
eicosapentaenoic acid (EPA).
[0097] The present invention further concerns a food product
comprising the food supplement of the present invention. Examples
of food products are as follows: [0098] 1. Food product comprising
whole seeds of Salvia sclarea: granola-like cereals, granola-like
snake bars, foodstuff for hens, cows, etc. After soaking in water
the whole seeds may be used in whole breads, rolls, crackers,
biscuits, etc. [0099] 2. For Salvia sclarea seeds, ground or milled
to produce flour/powder: granola-like cereals, granola-like snake
bars, and foodstuff for hens, cows, etc., whole breads, rolls,
crackers, biscuits, pasta and other baked goods. The flour/powder
may be used as thickener in gravy, soup, dips pressings and other
prepared food that typically contains flour of some sort as a
thickener. [0100] 3. For Salvia sclarea oil-formulated into oily
pastes or dips (tehini, humus) and in oils and paste such as sesame
oil or sesame paste, formulated into other vegetable oils or
margarine and margarine-like spreads, salad dressings, fish oil,
caviar-like products, etc. [0101] 4. The pulp (defatted seed
flour), due to its high fiber content, is extremely suitable for
the preparation of low calorie (diet) baked products (breads,
rolls) and also for the preparation of diet drinks and shakes with
high fiber, protein and mineral contents.
DETAILED DESCRIPTION OF THE INVENTION
[0102] Salvia sclarea has an average oil content of 25-30% in the
seeds, with maximum levels of 60% omega-3-linolenic acid of the
total fatty acids in the oil. Salvia sclarea lines were tested and
evaluated as a potential new oil crop for dietary supplement for
humans and animals, for use as an active ingredient in
pharmaceutical and cosmetic compositions and mixtures and for
industrial uses.
[0103] Omega-3 fatty acids from vegetable oils could provide all
the above health and cosmetic benefits without any of the
disadvantages of oil from animal sources.
[0104] Another important aspect of this vegetable oil is its
quality as drying oil, for painting and lubrication, due to the
high content of polyunsaturated fatty acids, namely linolenic acid.
Up to date, vegetative drying oil is obtained from crops such as
flax seeds and Tong trees. These crops do not lend themselves to
mechanical harvesting and cleaning, as does Salvia sclarea.
[0105] The Salvia sclarea oil of the present invention has many
advantages as compared to the previously know Salvia hispanica oil,
as can be seen, for example, by the following comparative analyses
in Tables 1-4:
[0106] Comparative analysis Salvia sclarea and Salvia hispanica
TABLE-US-00001 TABLE 1 General contents Test per 100 g Salvia
Sclarea Salvia hispanica % moisture (g/100 gr) 7.40 7.8 % protein
(g/100 gr) 23.38 21.1 % Fat (g/100 gr) 26.20 32.3 % Ash (g/100 gr)
5.77 4.8 % Crude Fiber (g/100 gr) 20.60 27.7 mg/100 g Calcium
0.82-0.928 0.0680 mg/100 g Phosphorus 0.70-0.682 0.780 mg/100
Potassium 1.02-1.29 0.809 g/100 g Dietary fibers 17.80 N/A
Saturated fat from total gr. fat 2.50 3.35
[0107] As can be seen the Salvia sclarea seeds have a higher
protein and dietary fiber contents than Salvia hispanica seeds.
TABLE-US-00002 TABLE 2 Fatty acids contents Range Fatty Acid Range
(Salvia (Salvia Profile hispanica) Sclarea) Myristic Acid C14:0
0.1-0.1 0 Palmitic Acid C16:0 6.6-6.7 6.8-8.0 Palmitoleic Acid
C16:1 0.1-0.1 Heptadecanoic Acid C17:0 0.2-0.2 Heptadecenoic Acid
C17:1 0.1-0.1 Stearic Acid C18:0 2.8-3.1 1.9-2.6 Oleic Acid C18:1
6.6-7.0 24.7-25.2 Linoleic Acid C18:2 18.6-18.9 12.1-14.8 Linolenic
Acid C18:3 (.omega. - 3) 58.2-59.1 49.9-56.0 Linolenic Acid C18:3
(.omega. - 6) 0.0-0.1 0-0.2 Arachidic Acid C20:0 0.3-0.3 Gadoleic
Acid C20:1 0.1-0.1 0.6 Eicosadienoic Acid C20:2 0.1-0.1
Eicosatrienoic Acid C20:3 (.omega. - 3) 0.1-0.1 Behenic Acid C22:0
0.1.0.1 0.1 Docosatetraenoic Acid C22:4 0.1-0.1 Lignoceric Acid C24
0.2-0.2 0.1 Total Fat 32.25% 26.2% Ratio : omega 3 omega 6 = 3.12
3.95 ##EQU00001##
[0108] As can be seen, the omega 3:omega 6 ratio in Salvia sclarea
seeds is higher than in Salvia hispanica seeds. Furthermore the
oleic acid contents in Salvia sclarea seeds is significantly higher
than in Salvia hispanica seeds.
TABLE-US-00003 TABLE 3 mineral profile In ( ) the Salvia Sclarea/
recommended USRDA mg in 100 g seeds Salvia hispanica (mg) mg/kg mg
in 100 g seeds Ag <0.05 AI 2.2 N/A Ag <0.05 <0.01 B 1.4
N/A Ba 2.3 N/A Be <0.01 N/A Ca (1000) 928 679.8 Cd <0.01
0.018 Co <0.05 0.25 Cr 0.03 0.5 Cu (2) 1.9 1.7 Fe 8.4 9.9 Hg
0.07 0.01 K (2500) 1290 809 Li <0.09 N/A Mg (400) 360 380 Mn (4)
4.3 N/A Mo 0.06 0.25 Na 17.3 12.15 Ni <0.05 0.25 p 682 780 Pb
<0.05 <0.035 s 261 290 Se (60 .mu.g) 0.06 (60 .mu.g) 1 Sr 2.2
N/A Ti <0.03 N/A V <0.05 N/A Zn 5.6 4.4
[0109] As can be seen, the calcium, potassium and selenium content
in the Salvia sclarea seeds are close to the RD A recommended
amounts.
TABLE-US-00004 TABLE 4 amino acid contents Total % Ess. a.a. in
Protein Sample 100 g Salvia Salvia Salvia USRDA sclarea seeds
Compound Sclarea hispanica g/day g/ukg 1 CysO3 1.06 1.82 2 Aspartic
9.65 9.47 3 Met. sulf 0.51 0.45 Threon. 0.5 4 Threonine 3.99 4.25
0.92 (Essential) 5 Serine 5.66 6.02 6 Glutamic 17.64 15.37 7
Proline 3.18 0.73 8 Glycine 6.16 5.23 9 Alanine 5.46 5.34 Val. 0.8
11 Valine (Essential) 5.05 6.32 Meth. 1.1 1.16 12 Methionine 0.51
0.45 Isoleu. 0.7 0.19 (Essential) 13 Isoleucine 3.79 3.98 Leu. 1.1
0.87 (Essential) 14 Leucine 7.78 7.30 1.78 (Essential) 15 Tyrosine
4.19 3.41 Phen. 1.1 16 Phenylalanine 6.32 5.86 N/A 1.45 (Essential)
17 Histidine 2.63 3.19 Lys. 0.8 0.60 (Essential) 18 Lysine
(Essential) 3.69 5.50 0.85 19 Gamma N/A arninobuty 20 Arginine
10.71 11.03 2.46 (essential) Total: .apprxeq.98% .apprxeq.96%
[0110] As can been seen, the amino acid contents in 100 g Salvia
sclarea supplies 50-160% of the USRDA essential amino acid
contents.
Example 1
Effect of Salvia sclarea Seed-Products on Hens
[0111] An experiment was conducted to measure the toxicity of
Salvia sclarea seed oil when administered as a dietary supplement
to laying hens, and the resultant level of omega-3 fatty acid, as
measured in the hens' body fat and in the resultant egg yolks.
[0112] 11 kg of Salvia sclarea seeds were milled into crude flour,
and mixed into standard hen feed at a concentration of 13.75% w/w.
Concentrations of 15-17% of the Salvia sclarea flour would also
have been appropriate, though they were not included in this
experiment. The feed containing the Salvia sclarea flour was stored
and used for the duration of the experiment, though typically hen
feed is prepared immediately before use.
[0113] 20 hens of the Yarkon variety were selected, having an age
of 8.5 months. At termination of the experiment, the hens numbered
18; this is consistent with the standard mortality rate. The laying
capacity was approximately 80-90% at the start of the experiment.
The hens were fed once or twice daily by hand, so that each hen
received approximately 120-130 gr. of feed, as estimated
visually.
[0114] During the first two days, the hens showed classical
symptoms seen when feed is changed. These symptoms disappeared
thereafter.
[0115] No change was observed in the quantity of feed consumed by
the hens, or in the degree of laying, though these values were not
physically measured. The quality of the eggs, their size and
breakage levels were not measured, but no change was visibly
apparent.
[0116] At the start of the experiment (Day 1), 10 eggs were
selected, refrigerated for 4 days, then their yolks were pooled and
sent for chemical analysis. Yolks were refrigerated until analysis
was performed. The yolk pool had a volume of 30 ml. The fatty acid
content, the Total Fat, and the cholesterol levels were analyzed,
and are presented in Table 5 below.
[0117] On Day 14 of the experiment, 10 additional eggs were
selected and their pooled yolks were sent for analysis.
[0118] On Day 29, 10 yolks were once again pooled and analyzed, and
10 control yolks were likewise pooled and analyzed. The control
yolks belong to hens raised in similar conditions; however, the
control group did not receive Salvia sclarea flour supplement in
the feed.
[0119] The experiment was discontinued at Day 34. Two hens were
then selected, one being a hen in the experiment group, and one
control hen. They were slaughtered and their body fat content was
analyzed. Results are shown in Table 6 below.
[0120] In this experiment, the nutritional value of the Salvia
sclarea seed itself was disregarded, though, for instance, feed
containing Salvia sclarea flour has a higher oil content than
standard feed.
[0121] Referring to Table 5, the percentage of linolenic acid
present in the egg contents increased dramatically by 617%. The
percentage of DHA increased as well, by 21%.
[0122] Referring to Table 6, the percentage of linolenic acid
present in the body fat of hens that consumed Salvia sclarea flour
rose dramatically, by 167%.
[0123] No toxicity was observed for Salvia sclarea seed flour.
[0124] These results demonstrate Salvia sclarea seeds are a viable
source of omega-3 fatty acids and that consumption of Salvia
sclarea seed flour results in a direct positive effect on the level
of omega-3 fatty acids in the consumer. Dietary supplements
containing Salvia sclarea seed flour or oil are thus nutritionally
recommended and could aid in preventing or ameliorating
arteriosclerosis and other conditions where high levels of omega-3
fatty acids have been found to be beneficial.
TABLE-US-00005 TABLE 5 Content of Eggs Produced by Hens after
Consumption of Salvia sclarea Seed Flour % Fatty Acids In Oil Fatty
acid Name Control Treated % change C14:0 Myristic 0.37 0.35 --
C16:0 Palmitic 24.64 23.36 -6 C16:1 Palmitolic 3.18 3.55 +5 C18:0
Stearic 9.23 7.68 -17 C18:1 Oleic 42.28 43.26 +2 C18:2 Linoleic
15.78 15.51 -2 C18:3 Linolenic 0.57 4.09 +617 C20:5 EPA C22:6 DHA
0.57 0.69 +21 Total fat in the 20.9 23.0 +10 egg (%) P/S ratio 0.47
0.69 +21
TABLE-US-00006 TABLE 6 Content of Hen Body Fat after Consumption of
Salvia sclarea Seed Flour % Fatty Acids in Oil Fatty acid Name
Control Treated % change C14:0 Myristic 0.52 0.54 +4 C16:0 Palmitic
18.84 19.55 +4 C16:1 Palmitolic 3.71 4.70 +27 C18:0 Stearic 5.89
5.51 -6 C18:1 Oleic 37.95 40.88 +8 C18:2 Linoleic 29.75 23.57 -21
C18:3 Linolenic 1.44 3.85 +167 Total hen's fat 55.3 37.6 -32 (%)
P/S ratio 1.23 1.07 -7 % S in 14.5 9.93 -32 Triglycerides
[0125] Based on the nutritional-chemical spectra of analysis, the
general conclusions are that Salvia sclarea seeds can be regarded
as nearly a nutritionally complete foodstuff.
Example 2
Calculations Concerning Salvia sclarea as a Food Supplement for
Human Consumption
[0126] According to the analysis shown in tables 1-4 above, it is
calculated that 100 grams of Salvia sclarea seeds per day will
supply approximately 40% to 50% of the required proteins, including
all the USRDA for essential Amino Acids (except a too low quantity
of Methionine), approximately 40% of the daily recommendations for
fats/oils (based on 2000 calories per day diet) with an excellent
fatty acid profile that contains approximately 50% omega-3 ALA, 25%
oleic acid, and 3.4 to 1 ratio of omega-3 to omega-6.
[0127] 100 grams per day of Salvia sclarea seeds will also supply
75% of the recommended USA daily values for dietary fiber based on
a 2000 calories diet (or 100% according the UK recommendations),
100% of the USRDA for most of the minerals (Ca, Mg, Cu, Se, Mn),
50% of the USRDA for Potassium (K) and Iron (Fe), 33% o for Zinc
(Zn) and Boron (B) 1.4 mg/100 g.
[0128] The Salvia sclarea seeds are also free of trans-fatty acids
and gluten, and absorb approximately 8 times their weight in water,
making them ideal for diet-low calorie foods, as fat replacement
products and water binders.
Example 3
Production of Salvia sclarea Flour/Powder
[0129] The Salvia sclarea seeds are ground into meal, blended with
natural antioxidants to prevent oil oxidation (rancidity) and to
prolong the shelf life of the product and then formulated as an
ingredient into weight reducing, nutritionally balanced powdered
drink mixes, bars and low-cal/low carbohydrate baked goods. As will
be shown below, however, antioxidants are not absolutely necessary
in light of the natural shelf life for the oil in the Salvia
sclarea seeds,
Example 4
Production of Cereals Snacks and Pasta
[0130] The Salvia sclarea seeds are ground into meal, partially
blended with whole seeds, formulated with other grain flours such
as wheat, barley, soy or corn, together with natural binders and
fibers, and then extruded by cooking extruders into flakes for
breakfast cereals, and other shapes for snacks, then flavored,
spiced, oil coated and baked (or fried) in oils blended with Salvia
sclarea omega-3 enriched vegetable oils.
[0131] For production by "cooking extruders," a dry blend of Salvia
sclarea meal and other ingredients are cooked together under high
pressure, using a single or twin co-rotating screws inside a barrel
with injection ports. Water and/or other liquids are injected into
the barrel during the cooking and blending process. The extruded
product is baked or air-dried, fried, and then flavored.
[0132] Formulations for cold extruded pasta products include usage
of special natural colorings, dough improvers, spices, flavorings,
fibers, etc., that render natural, omega-3 enriched pastas of
various shapes and colors.
[0133] The extruded products can be used as such (without further
processing) or mixed with other ingredients for production of
health oriented dry or cooked meals, breakfast cereals, granola
mixes, etc. Using state-of-the art formulations for cold-extrusion
systems omega-3 enriched pasta is obtained in various shapes and
colors (using natural colors also with antioxidant activities).
Example 5
Production of Low-Calorie Baked Goods
[0134] Salvia sclarea whole seeds are pretreated by soaking in
water or other suitable liquids or marinades, and then formulated
into low-calorie, nutritionally enhanced baked goods. For example,
in one embodiment a 250 calorie per 100 gram standard bread has its
energy reduced by 40% to a 150 calorie per 100 gram diet bread.
Similarly, a substantial reduction in calories applies to buns and
rolls, biscuits, bagels, etc. These low-calorie baked goods, which
are also omega 3 enriched, are suitable also for fast food chains
(buns for hotdogs or hamburgers), sandwiches, etc.
[0135] The Salvia sclarea seeds are marinated in buffered, flavored
and naturally colored solutions for varying lengths of time as
desired. Temperature and pH are controlled.
[0136] The marinated seeds and also Salvia sclarea flour/powder are
mixed into bread dough and other bakery products and baked
accordingly. The marinated seeds will render products containing
them low calorie products and also low-carbohydrates (low-carb.)
since the bound water marinade will react with the Salvia sclarea
fibers to form a soft jelly-type mixture.
Example 6
Production of Oil
[0137] Salvia sclarea seed oil is extracted from seeds, blended
with other oils, vegetable proteins, water, and natural emulsifying
and stabilizing ingredients and then homogenized by a homogenizer
and formed into a butter/margarine-like flavored spread, free of
trans fatty acids, very low in saturated fats, and high in omega-3
and oleic fatty acids.
[0138] Salvia sclarea seed oil is extracted from Salvia seeds by a
multi-stage press-extractor. Prior to extraction the seeds are
lightly heated and wetted for maximum yields.
[0139] The excess water is then removed by a decanting centrifuge.
The omega-3 rich and oleic acid rich oil is collected, blended with
natural oxidants, if desired, and bottled as such or blended with
other oils (see also Example 8), bottled or blended with other
ingredients (emulsifiers, stabilizers, water, etc.) and then
homogenized under vacuum to produce high omega-3 and oleic acid
butter-like spreads, vegetarian mayonnaise, etc.
Example 7
Production of Paste
[0140] Salvia sclarea seeds, rich in proteins, omega-3 oil and
soluble fibers are roasted and ground into a very fine paste by
proprietary equipment. The paste may be packed as is, as a high
nutritional base that can be used for thickening gravies, soups and
preparation of many oriental and Indian type dishes such as meat or
vegetarian satay, curries, hummus etc.
[0141] Additional usage can be to prepare dips such as tehini dip,
prepared in conjunction with sesame paste or oil, water, garlic,
lemon juice, spices and herbs. The tehini dip can be used as is or
made into salad dressings, etc.
[0142] A sesame/coffee type roaster is used for roasting and
controlled temperature heating of the Salvia sclarea seeds, which
are then ground and homogenized into an omega-3 rich tehini-type
paste.
Example 8
Production of Omega-3 Enriched Oil Preparations
[0143] Salvia sclarea whole seeds are washed and soaked in a water
solution of salts, acid regulators, natural antioxidants, natural
flavors and natural colors. Soaking times vary according to the
desired formulations. The soaked seeds are thoroughly drained of
excess solution.
[0144] The treated and drained seeds are blended with fish oils,
and natural marine flavors omega-3 EPA and DHA fatty acids in
desired ratios according to product recipe.
[0145] The finished product is packed in glass, plastic or metal
packaging and processed to render shelf stable or chilled products
with long shelf lives. These products are actually described as
vegetarian caviar (fish roe) like products with high nutritional
values that include all the nutritional factors of Salvia sclarea
seeds, and in addition the full group of omega-3 fatty acids (ALA,
DHA and EPA) from vegetable and marine sources.
[0146] In this embodiment, the Salvia sclarea whole seeds are
treated by soaking using a multi-stage battery of variable speed
mixers. The differential soaking solutions contain osmotic and acid
regulations, and natural antioxidants, flavors and colors. Time and
temperatures are controlled and the solutions treated seeds are
dewatered by low-speed centrifuges. The seeds are blended as
described, and then processed by pasteurization/sterilization
(according to pH of product) to yield shelf stable products.
Example 9
Production of Fish Feed Formulations
[0147] Salvia sclarea seeds are milled and blended at various
ratios into fish feed formulations.
[0148] This embodiment provides sweet water or salty water fish
with the entire range of nutritional benefits of Salvia sclarea
special oil rich in omega-3 alpha linolenic acid, omega-6 linoleic
acid and oleic acid.
[0149] The fish formulations are then extruded into floating or
sinking pellets according to the type of fish to be fed.
[0150] The raised fish will contain in their fillets a relatively
higher concentration of omega-3 fatty acids, which in turn can be
controlled by the concentration of ALA (C18:3) which is also a
precursor for natural synthesis of DHA (C22:6) in animal, poultry
and fish flesh.
[0151] These feed formulae contain all typical ingredients and
added Salvia(x) meal containing high value proteins, minerals and
omega-3 oils.
Example 10
Production of Packaged or Encapsulated Oil
[0152] Salvia sclarea seed oil rich in omega-3 ALA is extracted
from seeds. The oil is blended with olive and other vegetable oils,
rich in mono-unsaturated and omega-6 fatty acids and fortified with
natural proprietary antioxidants that will further prevent the oil
mixture from oxidation and also will provide beneficial
antioxidants (such as Vitamin E, Vitamin C and others) to the user.
When the Salvia sclarea seed oil is used alone, without mixing with
other oils, the need for antioxidants is substantially eliminated
because of the natural properties of this oil that make it very
slow to rancidify. See Example 11.
[0153] The ratio of monounsaturated fatty acids to omega-3 fatty
acid and omega-6 fatty acid is calculated to be 1 to 1/2 to 1/2, in
order to maintain the recommended ratio of 1/3 monousaturated fatty
acid, 1/3 polyunsaturated a fatty acid (with a ratio of 1 to 1
between omega-3 fatty acid and omega-6 fatty acid) and 1/3
saturated fatty acids of vegetable or animal origin (such as palm
oil, coconut oil, butter, etc.). All fats and oils should be
trans-free.
[0154] The total fats/oil per daily use is calculated to be 60 gr.
or 75 gr. (i.e., 27% of diets with 2000 calorie/day or 2500
calorie/day respectively).
[0155] About 2-3 grams a day of fish oils containing 1000 mg.
omega-3 DHA and EPA PUFA, are enclosed separately to the package,
in order to supply daily the whole range of omega-3 PUFA: ALA, EPA
and DHA.
[0156] The entire fatty acids/oils daily portion is packed in a 3
compartment package which will include in compartment 1 the fluid
oils blend (to be used in salads, cooking, etc.), in compartment 2
a spreadable saturated fatty acids mix (to be used by spreading on
crackers, bread slices, etc.) and in compartment 3, the omega-3
PUFA rich, fish oils (to be used with fish salads, dishes, etc., or
any other food with a compatible flavor).
[0157] The fish oil may also be encapsulated.
[0158] Special oil blends including natural herbal and other
antioxidants, and rich in omega-3 and oleic acids may be compounded
to yield nutritionally recommended ratios of omega-6:omega-3,
mono-unsaturated poly unsaturated and saturated fatty acids.
Example 11
ComparativeSility of Salvia sclarea Oil
[0159] It has been discovered that the Salvia sclarea seed oil has
a remarkable stability that far exceeds that of other known
vegetable oils that are rich in omega-3 fatty acids, such as Chia
(Salvia hispanica), flaxseed, hemp, and others. It is well known
that Chia oil has a substantial drawback as a commercial product
because of its low oxidative stability. See, for example, US
2011/0183033 to Gillot, which discloses a method of
microencapsulation of the Chia oil in order to overcome the
problems caused by Chia oil's lack of good oxidative stability. See
also US 2011/0306666 to Minatelli, which attests to the very poor
oxidative stability of Chia oil when not extracted under inert
gases and with antioxidants.
[0160] To test the stability of Salvia sclarea seed oil against
oxidation, the standard Rancimat test was conducted at various
temperatures. This test is detailed in Sullivan and Carpenter,
Methods of Analysis for nutrition labeling, AOAC International,
Chapter 1, 1993. The results were as follows:
TABLE-US-00007 Oil stability (105.degree. C.), hr 6.6 Oil stability
(120.degree. C.), hr 2.4 Oil stability (130.degree. C.), hr
0.85
[0161] This may be compared to the stability reported for Chia oil,
such as that reported in Ixtaina et al, "Oxidative Stability of
Chia (Salvia hispanica L.) Seed Oil: Effect of Antioxidants and
Storage Conditions," J Am Oil Chem Soc 89:1077-1090 (2012). That
article reports the induction time in hours as a result of the same
Rancimat test used above for analyzing S. sclarea oil, but
conducted at 98.degree. C., as being 2.3.+-.0.3. Thus, even at a
much lower temperature (98.degree. C.), the Chia oil became rancid
faster than S. sclarea oil tested at 120.degree. C. As the higher
the temperature, the more rapid the oxidation, it is clear that S.
sclarea oil is much more stable than is Chia oil. This
significantly enhanced stability over Chia oil is surprising and
unexpected.
Example 12
Assessment of Oxidative Deterioration of Salvia sclarea Seed Oil at
Ambient and Sunlight Storage
[0162] This study was carried out in order to probe the extent of
oxidative alterations in Salvia sclarea (Sage) seed oil, subjected
to ambient and sunlight storage, over a period of different times
and storage conditions. The results are shown in Tables 7-14.
[0163] The magnitude of oxidative changes was monitored by the
periodic measurement of peroxide value (PV) (analysis Method-AOCS
Cd 8b-90) and free fatty acid (FFA) content, (analysis Method-AOCS
Ca 5a-40). A twelve month oil of cold press Salvia sclarea seeds
was used from two different batches, with no addition of industrial
or natural stabilizers to the oil. The protein in oil was <0.1%,
moisture 0.04% max with an average 50% of ALA in the oil.
TABLE-US-00008 TABLE 7 Shelf life test 1: Glass bottle 250 cc of
Sage Oil Batch number: 11AE15 11AE15 11AE15 11AE15 11AE15 11AE15
11AE15 Days at 40.degree. C. 0 30 60 90 120 150 180 acceleration
Free fatty acid 0.92 1.03 1.02 1.08 1.13 0.96 0.92 content % as
oleic acid (FFA) peroxide 7.4 5 3.7 6.5 3.3 3 7.6 value (PV)
(meq/kg)
TABLE-US-00009 TABLE 8 Shelf life test 2: Glass bottle 250 cc of
Sage Oil Batch number: 12AE16 12AE16 12AE16 12AE16 12AE16 12AE16
12AE16 Days at 40.degree. C. 0 30 60 90 120 150 180 acceleration
Free fatty acid 1.11 1.18 1.21 1.3 1.35 1.37 1.08 content % as
oleic acid (FFA) peroxide 6.4 4.6 3.6 6.2 2.7 2.1 6.5 value (PV)
(meq/kg)
TABLE-US-00010 TABLE 9 Shelf life test 3: Glass bottle 250 cc of
Sage Oil Batch number: 11AE15 11AE15 11AE15 11AE15 11AE15 Days at
25.degree. C. 0 90 123 270 365 Free fatty acid 0.92 0.96 0.96 1.01
1.03 content % as oleic acid (FFA) peroxide 7.4 6 4.9 3.3 3.6 value
(PV) (meq/kg)
TABLE-US-00011 TABLE 10 Shelf life test 4: Glass bottle 250 cc of
Sage Oil Batch number: 12AE16 12AE16 12AE16 12AE16 12AE16 Days at
25.degree. C. 0 90 123 270 365 Free fatty acid 1.11 1.2 1.13 1.25
1.22 content % as oleic acid (FFA) peroxide 6.4 5.5 4.3 3 2.9 value
(PV) (meq/kg)
TABLE-US-00012 TABLE 11 Shelf life test 5: PET bottle 250 cc of
Sage Oil Batch number: 11AE15 11AE15 11AE15 11AE15 11AE15 Days at
-22.degree. C. 0 90 123 270 365 Free fatty acid 0.92 0.94 0.95 0.91
0.97 content % as oleic acid (FFA) peroxide 7.4 8.1 7.2 5.6 5.7
value (PV) (meq/kg)
TABLE-US-00013 TABLE 12 Shelf life test 6: PET bottle 250 cc of
Sage Oil Batch number: 12AE16 12AE16 12AE16 12AE16 12AE16 Days at
-22.degree. C. 0 90 123 270 365 Free fatty acid 0.92 1.16 1.09 0.88
1.03 content % as oleic acid (FFA) peroxide 7.4 6.7 6.6 11.7 5.4
value (PV) (meq/kg)
TABLE-US-00014 TABLE 13 Shelf life test 7: Glass bottle 250 cc of
Sage Oil Batch number: 11AE15 11AE15 11AE15 Days at 4.degree. C. 0
180 365 Free fatty acid 0.92 0.94 0.96 content % as oleic acid
(FFA) peroxide 7.4 7.6 5.3 value (PV) (meq/kg)
TABLE-US-00015 TABLE 14 Shelf life test 8: Glass bottle 250 cc of
Sage Oil Batch number: 12AE16 12AE16 12AE16 Days at 4.degree. C. 0
180 365 Free fatty acid 1.11 1.08 1.13 content % as oleic acid
(FFA) peroxide 6.4 6.5 4.7 value (PV) (meq/kg)
[0164] These results may be contrasted to the PV values for flax
seed oil, such as those reported in Hamed and Abo-Elwafa,
"Enhancement of oxidation stability of flax seed oil by blending
with stable vegetable oils," J App Sci Res 8:5039-5048 (2012). This
publication reports that relatively short shelf-life of most
commercially available vegetable oils limits their usefulness in
various applications. It further states that flax seed oil, with
the high levels of PUFA, is more readily oxidized if stored or
handled improperly. While accelerated at 62.degree. C., the PV
values for pure flax seed oil (FO) in FIG. 4, are extremely high as
compared to the results above for S. sclarea seed oil.
[0165] See also the peroxide value (PV) for Chia oil as reported in
FIG. 4 of Ixtaina (2012), supra. It shows that fresh Chia oil at
20.degree. C. after 195 days has a PV of 20. This may be compared
with one year Salvia sclarea oil at 25.degree. C. after 270 days,
which has a PV of only 3.3 and one year Salvia sclarea oil at
40.degree. C. after 365 days, which has a PV of only 3.6.
[0166] The extremely high stability of S. sclarea seed oil, as
compared to other oils high in omega-3, is surprising and
unexpected.
* * * * *