U.S. patent application number 12/206838 was filed with the patent office on 2009-05-07 for carotenoid-containing compositions and methods.
This patent application is currently assigned to Bristol-Myers Squibb Company. Invention is credited to Zeina Jouni, Zeina Makhoul.
Application Number | 20090118227 12/206838 |
Document ID | / |
Family ID | 40588756 |
Filed Date | 2009-05-07 |
United States Patent
Application |
20090118227 |
Kind Code |
A1 |
Jouni; Zeina ; et
al. |
May 7, 2009 |
CAROTENOID-CONTAINING COMPOSITIONS AND METHODS
Abstract
The present invention is directed to carotenoid compositions and
methods for inhibiting the growth of pathogenic bacteria or for
preventing or treating bacterial infections in subjects by
administration of an effective amount of astaxanthin and
beta-carotene.
Inventors: |
Jouni; Zeina; (Evansville,
IN) ; Makhoul; Zeina; (Tucson, AZ) |
Correspondence
Address: |
BRISTOL-MYERS SQUIBB COMPANY - MEAD JOHNSON
2400 WEST LLOYD EXPRESSWAY, PATENT DEPARTMENT
EVANSVILLE
IN
47721
US
|
Assignee: |
Bristol-Myers Squibb
Company
|
Family ID: |
40588756 |
Appl. No.: |
12/206838 |
Filed: |
September 9, 2008 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
60986029 |
Nov 7, 2007 |
|
|
|
Current U.S.
Class: |
514/54 ;
514/691 |
Current CPC
Class: |
A23L 5/44 20160801; A23L
33/10 20160801; A23V 2002/00 20130101; A23L 33/26 20160801; A23L
33/40 20160801; A61P 31/04 20180101; A61P 3/04 20180101; A23V
2002/00 20130101; A23V 2200/32 20130101; A23V 2200/3202 20130101;
A23V 2250/211 20130101; A23V 2002/00 20130101; A23V 2200/332
20130101; A23V 2200/3202 20130101; A23V 2250/211 20130101 |
Class at
Publication: |
514/54 ;
514/691 |
International
Class: |
A61K 31/122 20060101
A61K031/122; A61K 31/715 20060101 A61K031/715; A61P 3/04 20060101
A61P003/04; A61P 31/04 20060101 A61P031/04 |
Claims
1. A nutritional composition comprising astaxanthin, beta-carotene,
galacto-oligosaccharide, and polydextrose.
2. The nutritional composition of claim 1 wherein the nutritional
composition contains astaxanthin in an amount within the range of
from about 50 to about 1150 mcg/L.
3. The nutritional composition of claim 1 wherein the nutritional
composition contains beta-carotene in an amount within the range of
from about 50 to about 1150 mcg/L.
4. The nutritional composition of claim 1 wherein the nutritional
composition contains a combination of astaxanthin and beta-carotene
in an amount within the range of from about 100 to about 1500
mcg/L.
5. The nutritional composition of claim 1 wherein the nutritional
composition contains galacto-oligosaccharide in an amount in the
range of from about 1.0 g/L to about 4.0 g/L.
6. The nutritional composition of claim 1 wherein the nutritional
composition contains polydextrose in an amount within the range of
from about 1.0 g/L to about 4.0 g/L.
7. The nutritional composition of claim 1 additionally comprising
at least one long-chain polyunsaturated fatty acid selected from
the group consisting of docosahexaenoic acid, arachidonic acid,
eicosapentaenoic acid, and combinations thereof.
8. The nutritional composition of claim 1 wherein the nutritional
composition is in a form selected from those consisting of an
infant formula, human milk fortifier, and children's nutritional
product.
9. The nutritional composition of claim 1 wherein the nutritional
composition is in a form selected from those consisting of powder
and liquid.
10. A method for inhibiting the growth of pathogenic bacteria in a
subject comprising administering to the subject an effective amount
of astaxanthin and beta-carotene.
11. The method of claim 10 wherein the effective amount of
astaxanthin is within the range of about 0.01 mg and about 10 mg
per kg body weight per day.
12. The method of claim 10 wherein the effective amount of
astaxanthin is about 1 mg per kg body weight per day.
13. The method of claim 10 wherein the effective amount of
beta-carotene is within the range of about 0.01 mg and about 10 mg
per kg body weight per day.
14. The method of claim 10 wherein the effective amount of
beta-carotene is about 1 mg per kg body weight per day.
15. The method according to claim 10 additionally comprising the
administration of at least one prebiotic.
16. The method according to claim 15 wherein the prebiotic
comprises a combination of galacto-oligosaccharide and
polydextrose.
17. The method according to claim 10 wherein the pathogenic
bacteria is H. pylori.
18. A method for inhibiting the growth of H. pylori in an infant
comprising administering to the infant an infant formula containing
an effective amount of astaxanthin and beta-carotene.
19. A method for preventing or treating a bacterial infection in a
subject comprising administering to the subject the composition of
claim 1.
20. A method for preventing obesity in a subject comprising
administering to the subject the composition of claim 1.
Description
CROSS-REFERENCE TO RELATED PATENT APPLICATIONS
[0001] This application claims the priority benefit of U.S.
Provisional Application No. 60/986,029, filed Nov. 7, 2007, which
is incorporated by reference herein in its entirety.
BACKGROUND OF THE INVENTION
[0002] (1) Field of the Invention
[0003] The present invention relates generally to
carotenoid-containing compositions, methods for inhibiting the
growth of pathogenic bacteria, and methods for preventing or
treating a bacterial infection in a subject via the administration
of carotenoids.
[0004] (2) Description of the Related Art
[0005] Approximately two-thirds of the world's population is
infected with Helicobacter pylori bacteria. Many people that are
infected with the bacteria never suffer any symptoms related to the
infection. In some cases, however, H. pylori infection can cause
chronic active, chronic persistent, or atrophic gastritis.
Infection with H. pylori also causes duodenal and gastric ulcers.
In fact, H. pylori causes more than 90% of duodenal ulcers and 80%
of gastric ulcers. The infection has additionally been associated
with dyspepsia, iron-deficient anemia, and gastric malignancy.
Further, approximately 15% of infected individuals will at some
time develop peptic ulcer disease or gastric adenocarcinoma, which
is the second most common cause of cancer deaths worldwide.
Solnick, et al., Natural Acquisition of Helicobacter pylori
Infection in Newborn Rhesus Macaques, J. Clin. Microbio. 41(12):
5511-5516 (2003).
[0006] Helicobacter pylori, which was previously known as
Campylobacter pylori, is a gram-negative, spiral-shaped bacterium.
It protects itself from the harsh acidic environment of the stomach
by covering itself with the mucus of the stomach. Once covered, it
is able to fight any stomach acid that does reach it with urease,
an enzyme it possesses. Once nestled within the stomach mucus, H.
pylori is able to penetrate the protective lining of the stomach,
induce inflammatory cytokines, and cause gastric inflammation.
[0007] It is not currently known how H. pylori is transmitted or
why some people become symptomatic while others do not. The
bacteria are most likely spread from person to person through
fecal-oral or oral-oral routes. Contaminated water or food sources
may also contribute to the transmission of the bacteria.
[0008] The avoidance of H. pylori infection in infants and children
is particularly important, as the incidence of H. pylori infection
is greatest in childhood, particularly in developing countries
where infection rates can be as high as 50% by age 5 years. Precise
estimates of the age of acquisition of the invention are difficult
to obtain because most children that are infected are asymptomatic.
Even without symptoms, however, the infection can develop into more
dangerous conditions such as antral gastritis, the most common
manifestation in children. In addition, if an individual becomes
infected with H. pylori during childhood, the infection may remain
in his system throughout the course of his life, potentially
leading to other diseases in adulthood.
[0009] Treatment for H. pylori infection currently consists of 10
days to 2 weeks of antibiotic treatment, such as with amoxicillin,
tetracycline, metronidazole, or clarithromycin, plus either
ranitidine bismuth citrate, bismuth subsalicylate, or a proton pump
inhibitor. The disadvantage to widespread antibiotic treatment is
the development of antibiotic resistance. The H. pylori infection
has previously been shown to be resistant to several antibiotic
treatments, contributing to treatment failure in a number of cases.
F Megraud, H pylori Antibiotic Resistance: Prevalence, Importance,
and Advances in Testing, Gut 53: 1374-1384 (2004). In a particular
study, 29% of the H. pylori strains tested were resistant to
clarithromycin, 24% to metronidazole, and 10% were resistant to
both clarithromycin and metronidazole. Kato, et al., Antibiotic
Resistance of Helicobacter pylori Strains in Japanese Children, J.
Clin. Microbio. 40(2): 649-653 (2002). Thus, infected individuals
cannot be assured that antibiotic treatment will be effective.
[0010] Therefore, a need remains for a method for preventing or
treating H. pylori infection in subjects. It would also be
beneficial to provide a method for achieving such prevention or
treatment through the use of compositions other than traditional
antibiotics.
SUMMARY OF THE INVENTION
[0011] Briefly, therefore, the present invention is directed to a
nutritional composition comprising astaxanthin, beta-carotene,
galacto-oligosaccharide, and polydextrose.
[0012] In another embodiment, the invention is directed to a method
for inhibiting the growth of pathogenic bacteria in a subject
comprising administering to the subject an effective amount of
astaxanthin and beta-carotene.
[0013] The invention is additionally directed to a method for
inhibiting the growth of H. pylori in an infant comprising
administering to the infant an infant formula containing an
effective amount of astaxanthin and beta-carotene.
[0014] In other embodiments, the invention is directed to a method
for preventing or treating a bacterial infection or preventing
obesity in a subject comprising administering to the subject a
nutritional composition comprising astaxanthin, beta-carotene,
galacto-oligosaccharide, and polydextrose.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0015] Reference now will be made in detail to the embodiments of
the invention, one or more examples of which are set forth below.
Each example is provided by way of explanation of the invention,
not a limitation of the invention. In fact, it will be apparent to
those skilled in the art that various modifications and variations
can be made in the present invention without departing from the
scope or spirit of the invention. For instance, features
illustrated or described as part of one embodiment, can be used on
another embodiment to yield a still further embodiment.
[0016] Thus, it is intended that the present invention covers such
modifications and variations as come within the scope of the
appended claims and their equivalents. Other objects, features and
aspects of the present invention are disclosed in or are obvious
from the following detailed description. It is to be understood by
one of ordinary skill in the art that the present discussion is a
description of exemplary embodiments only, and is not intended as
limiting the broader aspects of the present invention.
[0017] Carotenoids are a related group of greater than 600 natural
compounds, irrespective of geometric and stereoisomers, with
demonstrated antioxidant efficacy. The carotenoids are broadly
divided into "carotenes," or non-oxygen substituted hydrocarbon
carotenoids, and "xanthophylls," oxygen-substituted carotenoids.
Between 500 and 600 carotenoids have been identified, of which only
about 24 occur in human foodstuffs. The major carotenoids found in
foods are .alpha.-carotene, .beta.-carotene, lycopene, lutein,
zeaxanthin, and .beta.-cryptoxanthin. They are present in foods
such as carrots, pumpkins, sweet potatoes, tomatoes, and other deep
green, yellow, orange, red fruits and vegetables. Most carotenoids
occur in nature predominantly in the all-trans form. Three of these
carotenoids, .alpha.-carotene, .beta.-carotene and
.beta.-cryptoxanthin, can be converted into retinol and are
therefore considered provitamin A carotenoids. Lycopene, lutein and
zeaxanthin do not have a vitamin A function and are referred to as
nonprovitamin A carotenoids.
[0018] An important feature of carotenoids is a centrally located,
extended conjugated double-bond system, which is responsible for
the chemical reactivity, light-absorbing properties, and, thus, the
color of carotenoids. Potential biological function is determined
by the chemical structure of carotenoids. The alternating single
and double bond of the polyene backbone of carotenoids allow them
to absorb excess energy from other molecules, which accounts for
their antioxidant properties. They perform their antioxidant
function by either quenching singlet oxygen and/or blocking free
radical-mediated reactions. The polarity of the specific end groups
of carotenoids accounts for the differences in how they interact
with biological membranes. Carotenoids are associated with lipid
portions of human tissues, cells, and membranes and bind to
hydrophobic surfaces because they are lipophilic. In addition,
carotenoids are easily isomerized and oxidized due to their high
unsaturation and hence may lose biological activity after
processing and storage.
[0019] In recent years, carotenoids have received the interest of
researchers from diverse fields including food science, pharmacy,
biochemistry and nutrition because of their wide spectrum of
biological functions such as provitamin A, antioxidant,
immuno-enhancement, and prevention of degenerative diseases.
[0020] For example, see U.S. Pat. No. 7,090,879 to Albrecht, et
al., U.S. Pat. No. 6,268,450 to Asami, et al., U.S. Pat. No.
6,727,373 to Bijl, et al., U.S. Patent App. Pub. No. 2003/0175364
to Newman, et al, or U.S. Patent App. Pub. No. 2006/0068019 to
Dalziel, et al.
[0021] The technical problem to be solved by the present invention
is to provide novel carotenoid nutritional compositions that are
useful in inhibiting the growth of pathogenic bacteria and/or
preventing or treating bacterial infections in subjects. Thus, in
an embodiment, the present invention is directed to a nutritional
composition comprising astaxanthin, beta-carotene,
galacto-oligosaccharide, and polydextrose. The present invention is
also directed, in an embodiment, to a method for inhibiting the
growth of pathogenic bacteria or for preventing or treating
bacterial infections in subjects by administering to them an
effective amount of astaxanthin and beta-carotene.
[0022] Astaxanthin is a fat-soluble, oxygenated pigment which is
classified as a xanthophyll and is a member of the carotenoid
family. It has a unique molecular structure that gives it powerful
antioxidant function. It can be extracted from salmon, microalgae,
and Pfaffia, a yeast. Current research shows that due to
astaxanthin's potent antioxidant activity, it may be beneficial in
cardiovascular, immune, anti-inflammatory, and neurodegenerative
diseases. Specifically, its varied actions include: inhibition of
lipid peroxidation at the cell level; crossing the blood-brain
barrier, effecting treatment of ocular and neurodegenerative
diseases such as glaucoma and Alzheimer's; entrapment of free
radicals by adding them to its long, double-bonded chain rather
than donating an electron; stabilization of the cell membrane via
its polar end groups spanning the cell membrane and increasing its
rigidity and mechanical strength; neutralization of singlet and
triplet oxygen (de-charges) generated by UVA and UVB radiation and
other sources; binding to a lipoprotein, an efficient transport
vehicle, making it more bioavailable; increase of immune system
function including heightened production of antibody-secreting
cells and Interleukin 2 and suppression of Interferon-gamma;
inhibition of reactive oxygen species that cause inflammation;
enhancing of the antioxidant actions of Vitamin E and Vitamin C;
and encouraging the release of Vitamin A from the liver when
needed.
[0023] Astaxanthin provides significantly more antioxidant capacity
than other carotenoids and antioxidants such as beta-carotene and
Vitamin E. In fact, Astaxanthin has 100-500 times the antioxidant
capacity of Vitamin E and 10 times the antioxidant capacity of
beta-carotene. Many laboratory studies also indicate astaxanthin is
a stronger antioxidant than lutein, lycopene and tocotrienols.
Astaxanthin is often added to food products or nutritional
supplements for its antioxidant effects.
[0024] The structure of astaxanthin is shown below:
##STR00001##
[0025] In an embodiment of the invention, the effective amount of
astaxanthin is within the range of about 0.01 mg and about 10 mg
per kg body weight per day. In another embodiment of the invention,
the effective amount of astaxanthin is within the range of about
0.1 mg and about 5 mg per kg body weight per day. In a particular
embodiment of the invention, the effective amount of astaxanthin is
about 1 mg per kg body weight per day.
[0026] Like astaxanthin, beta-carotene is a carotenoid.
Beta-carotene is the most common of the carotenes and can be found
in yellow, orange, and green leafy fruits and vegetables. It is
unclear whether beta-carotene has any biological function for
humans other than as a precursor for vitamin A. There is some
evidence that beta-carotene may play a beneficial role in human
nutrition beyond its provitamin A function. Beta-carotene has
antioxidant activity, at least in vitro, and it may enhance
intercellular communication and may have immunomodulatory and
anticarcinogenic activities in certain circumstances.
[0027] The structure of beta-carotene is set forth below:
##STR00002##
[0028] In an embodiment of the invention, the effective amount of
beta-carotene is within the range of about 0.01 mg and about 10 mg
per kg body weight per day. In another embodiment of the invention,
the effective amount of beta-carotene is within the range of about
0.1 mg and about 5 mg per kg body weight per day. In a particular
embodiment of the invention, the effective amount of beta-carotene
is about 1 mg per kg body weight per day.
[0029] As used in the present invention, the source of either
astaxanthin or beta-carotene can be any source known in the art
such as plant material, seafood, and/or single cell. In certain
embodiments, either of astaxanthin or beta-carotene may be in raw
form or may be chemically manipulated. In a particular embodiment,
either of astaxanthin or beta-carotene may be genetically modified
organisms.
[0030] As noted, the present invention is directed, in certain
embodiments, methods for inhibiting the growth of pathogenic
bacteria or for preventing or treating bacterial infections in
subjects by administering to them an effective amount of
astaxanthin and beta-carotene. The pathogenic bacteria which
experience growth inhibition as a result of the invention may be
any pathogenic bacteria known in the art. In a particular
embodiment, the pathogenic bacteria is H. pylori. Likewise, the
bacterial infection of the invention may be any known in the art,
but in a particular embodiment, is H. pylori infection.
[0031] In an embodiment, the astaxanthin and beta carotene may be
administered in the form of a nutritional composition, infant
formula, human milk supplement, or children's nutritional product.
As used herein, the term "infant formula" means a composition that
satisfies the nutrient requirements of an infant by being a
substitute for human milk. Thus, the method of the invention is
useful in preventing or treating bacterial infections in human
infants, children, or adults.
[0032] If the astaxanthin and beta-carotene are administered via an
infant formula, the infant formula may be nutritionally complete
and contain suitable types and amounts of lipid, carbohydrate,
protein, vitamins and minerals. The amount of lipid or fat
typically can vary from about 3 to about 7 g/100 kcal. The amount
of protein typically can vary from about 1 to about 5 g/100 kcal.
The amount of carbohydrate typically can vary from about 8 to about
12 g/100 kcal. Protein sources can be any used in the art, e.g.,
nonfat milk, whey protein, casein, soy protein, hydrolyzed protein,
and/or amino acids. Carbohydrate sources can be any used in the
art, e.g., lactose, glucose, corn syrup solids, maltodextrins,
sucrose, starch, and/or rice syrup solids. Lipid sources can be any
used in the art, e.g., vegetable oils such as palm oil, canola oil,
corn oil, soybean oil, palmolein, coconut oil, medium chain
triglyceride oil, high oleic sunflower oil, and/or high oleic
safflower oil.
[0033] Conveniently, commercially available nutritional
compositions, infant formulas, human milk supplements, or
children's nutritional products can be used. For example, Enfalac,
Enfamil.RTM., Enfamil.RTM. Premature Formula, Enfamil.RTM. with
Iron, Enfamil.RTM. LIPIL.RTM., Lactofree.RTM., Nutramigen.RTM.,
Pregestimil.RTM., and ProSobee.RTM. (available from Mead Johnson
& Company, Evansville, Ind., U.S.A.) may be supplemented with
suitable levels of astaxanthin and beta-carotene and used in
practice of the invention.
[0034] If the astaxanthin and beta-carotene are administered in an
infant formula, the amounts of each carotenoid in the formula may
be up to about 40 nmol/g fat. In another embodiment, the amounts of
each carotenoid in the formula may be within the range of about 2
nmol/g and about 35 nmol/g fat. In a particular embodiment, the
amounts of each carotenoid in the formula may be within the range
of about 5 nmol/g and about 30 nmol/g fat.
[0035] The total carotenoid blend may comprise, in an embodiment,
up to about 2000 mcg/L infant formula. In other embodiments, the
total carotenoid blend may comprise from about 100 to about 1500
mcg/L infant formula. In yet another embodiment, the total
carotenoid blend may comprise from about 200 to about 1200 mcg/L
infant formula.
[0036] The individual carotenoids may be present in the infant
formula in an amount of from about 50 to about 1150 mcg/L, about 75
to about 230 mcg/L, or about 100 to about 200 mcg/L.
[0037] In some embodiments of the invention, additional components
may be administered in combination with astaxanthin and
beta-carotene. These additional components may include probiotics,
prebiotics, or long chain polyunsaturated fatty acids (LCPUFAs).
The components may be administered separately from the astaxanthin
and beta-carotene or may be included as part of a nutritional
composition, infant formula, human milk supplement, or children's
nutritional product that contains astaxanthin, beta-carotene, and
one or more additional components.
[0038] The term "probiotic" means a microorganism that exerts
beneficial effects on the health of the host. Any probiotic known
in the art may be used, provided it is suitable for combination
with the other components of the supplement. For example, the
probiotic may be chosen from the group consisting of Lactobacillus
and Bifidobacterium. Alternatively, the probiotic can be
Lactobacillus rhamnosus GG.
[0039] The term "prebiotic", as used herein, means a non-digestible
food ingredient that stimulates the growth and/or activity of
probiotics. In this embodiment, any prebiotic known in the art may
be used, provided it is suitable for combination with the other
components of the supplement. In a particular embodiment, the
prebiotic can be selected from the group consisting of
fructo-oligosaccharide, gluco-oligosaccharide,
galacto-oligosaccharide, inulin, isomalto-oligosaccharide,
polydextrose, xylo-oligosaccharide, lactulose, and combinations
thereof. In a particular embodiment, the prebiotic is a mixture of
galacto-oligosaccharide and polydextrose.
[0040] In an embodiment, the total amount of prebiotics present in
the nutritional composition may be from about 1.0 g/L to about 10.0
g/L of the composition. In another embodiment, the total amount of
prebiotics present in the nutritional composition may be from about
2.0 g/L and about 8.0 g/L of the composition. In yet another
embodiment, the total amount of prebiotics present in the
nutritional composition may be about 4.0 g/L of the
composition.
[0041] If galacto-oligosaccharide is used as a prebiotic, the
amount of galacto-oligosaccharide in the nutritional composition
may, in an embodiment, be within the range of from about 1.0 g/L to
about 4.0 g/L. In another embodiment, the amount of
galacto-oligosaccharide in the nutritional composition may be about
2.0 g/L. If polydextrose is used as a prebiotic, the amount of
polydextrose in the nutritional composition may, in an embodiment,
be within the range of from about 1.0 g/L to about 4.0 g/L. In
another embodiment, the amount of polydextrose in the nutritional
composition may be about 2.0 g/L. In a particular embodiment,
galacto-oligosaccharide and polydextrose are supplemented into the
nutritional composition in a total amount of about 4.0 g/L. In this
embodiment, the amount of galacto-oligosaccharide may be about 2.0
g/L and the amount of polydextrose may be about 2.0 g/L.
[0042] While not wishing to be bound to this or any theory, it is
believed that the administration of prebiotics and carotenoids may
provide a synergistic effect. More specifically, it is believed
that the prebiotic may alter the composition of the gut flora to
provide a greater number of beneficial bacteria and fewer
pathogenic bacteria, further contributing to the antimicrobial
effect of the carotenoids in the present invention.
[0043] In yet another embodiment of the invention, LCPUFAs may be
administered in combination with astaxanthin and beta-carotene. In
this embodiment, the LCPUFAs may include docosahexaenoic acid
(DHA), arachidonic acid (ARA), and/or eicosapentaenoic acid
(EPA).
[0044] If administered as part of the present invention, the weight
ratio of ARA:DHA may be from about 1:3 to about 9:1. In one
embodiment of the present invention, this ratio is from about 1:2
to about 4:1. In yet another embodiment, the ratio is from about
2:3 to about 2:1. In one particular embodiment the ratio is about
2:1. In another particular embodiment of the invention, the ratio
is about 1:1.5. In other embodiments, the ratio is about 1:1.3. In
still other embodiments, the ratio is about 1:1.9. In a particular
embodiment, the ratio is about 1.5:1. In a further embodiment, the
ratio is about 1.47:1.
[0045] If administered as part of the present invention, the level
of DHA may be within the range of about 0.0% and about 1.00% of
fatty acids, by weight. In other embodiments, the level of DHA may
be about 0.32% by weight. In some embodiments, the level of DHA may
be about 0.33% by weight. In another embodiment, the level of DHA
may be about 0.64% by weight. In another embodiment, the level of
DHA may be about 0.67% by weight. In yet another embodiment, the
level of DHA may be about 0.96% by weight. In a further embodiment,
the level of DHA may be about 1.00% by weight.
[0046] If administered as part of the present invention, the level
of ARA may be within the range of 0.0% and 0.67% of fatty acids, by
weight. In another embodiment, the level of ARA may be about 0.67%
by weight. In another embodiment, the level of ARA may be about
0.5% by weight. In yet another embodiment, the level of DHA may be
within the range of about 0.47% and about 0.48% by weight.
[0047] If administered as part of the present invention, the amount
of DHA may be from about 2 mg/100 kilocalories (kcal) to about 100
mg/100 kcal. In another embodiment, the amount of DHA may be from
about 5 mg/100 kcal to about 75 mg/100 kcal. In yet another
embodiment, the amount of DHA may be from about 15 mg/100 kcal to
about 60 mg/100 kcal.
[0048] If administered as part of the present invention, the amount
of ARA may be from about 4 mg/100 kilocalories (kcal) to about 100
mg/100 kcal. In another embodiment, the amount of ARA may be from
about 10 mg/100 kcal to about 67 mg/100 kcal. In yet another
embodiment, the amount of ARA may be from about 20 mg/100 kcal to
about 50 mg/100 kcal. In a particular embodiment, the amount of ARA
may be from about 25 mg/100 kcal to about 40 mg/100 kcal. In one
embodiment, the amount of ARA is about 30 mg/100 kcal.
[0049] If administered as part of the present invention, the
effective amount of DHA may be from about 3 mg per kg of body
weight per day to about 150 mg per kg of body weight per day. In
one embodiment of the invention, the amount is from about 6 mg per
kg of body weight per day to about 100 mg per kg of body weight per
day. In another embodiment the amount is from about 15 mg per kg of
body weight per day to about 60 mg per kg of body weight per
day.
[0050] If administered as part of the present invention, the
effective amount of ARA may be from about 5 mg per kg of body
weight per day to about 150 mg per kg of body weight per day. In
one embodiment of this invention, the amount varies from about 10
mg per kg of body weight per day to about 120 mg per kg of body
weight per day. In another embodiment, the amount varies from about
15 mg per kg of body weight per day to about 90 my per kg of body
weight per day. In yet another embodiment, the amount varies from
about 20 mg per kg of body weight per day to about 60 mg per kg of
body weight per day.
[0051] If the composition of the invention is supplemented with
oils containing LCPUFAs, it may be accomplished using standard
techniques known in the art. For example, an equivalent amount of
an oil which is normally present in a composition, such as high
oleic sunflower oil, may be replaced with the LCPUFAs.
[0052] If utilized, the source of the LCPUFAs can be any source
known in the art such as marine oil, fish oil, single cell oil, egg
yolk lipid, and/or brain lipid. The LCPUFAs can be in natural form
or refined form.
[0053] In other embodiments of the invention, astaxanthin and
beta-carotene may be combined and administered to a subject for the
purpose of treating or preventing any of the following: reflux,
spitting up, abdominal pain, bloating, vomiting, gastric
inflammation, gastritis, ulcer formation, hypertension,
dyslipidemia, Type I and II diabetes, insulin sensitivity, obesity,
cardiovascular disease, cancer, atherosclerosis. In other
embodiments, astaxanthin and beta-carotene can be combined and
administered for the purpose of improving digestion or stool
consistency, modulating antioxidant enzymes, decreasing cellular
and tissue oxidative stress, shifting T-helper cell Types 1 to Th2
balance, and modulating immune function.
[0054] In some embodiments, the invention includes a method for
improving weight management in a subject comprising administering
to the subject an effective amount of astaxanthin and
beta-carotene. In other embodiments, the invention includes a
method for preventing or treating obesity in a subject comprising
administering to the subject an effective amount of astaxanthin and
beta-carotene. Obesity has been linked with an inflammation of
adipose tissue. In some studies, inflammation has also been
identified as an early characteristic of obesity. The combination
of astaxanthin and beta-carotene, in addition to their antioxidant
benefits, may contribute to a reduction in inflammation, thereby
reducing or preventing the onset of obesity in the present
invention.
[0055] In an embodiment, the invention is directed to the use of a
combination of astaxanthin and beta-carotene in the manufacture of
an ingestible composition for inhibiting the growth of pathogenic
bacterial in a subject. In another embodiment, the invention is
directed to the use of a combination of astaxanthin and
beta-carotene in the manufacture of an ingestible composition for
inhibiting the growth of H. pylori in an infant. In yet another
embodiment, the invention is directed to the use of a combination
of astaxanthin and beta-carotene in the manufacture of an
ingestible composition for preventing or treating a bacterial
infection in a subject. In still another embodiment, the invention
is directed to the use of a combination of astaxanthin and
beta-carotene in the manufacture of an ingestible composition for
preventing obesity in a subject.
[0056] The invention, in an embodiment, is also directed to a
combination of astaxanthin and beta-carotene for use in inhibiting
the growth of pathogenic bacteria in a subject. The invention is
also directed, in an embodiment, to a combination of astaxanthin
and beta-carotene for use in inhibiting the growth of H. pylori in
an infant. Additionally, the invention is directed, in an
embodiment, to a combination of astaxanthin and beta-carotene for
use in preventing or treating a bacterial infection in a
subject.
[0057] All references cited in this specification, including
without limitation, all papers, publications, patents, patent
applications, presentations, texts, reports, manuscripts,
brochures, books, internet postings, journal articles, and/or
periodicals are hereby incorporated by reference into this
specification in their entireties. The discussion of the references
herein is intended merely to summarize the assertions made by their
authors and no admission is made that any reference constitutes
prior art. Applicants reserve the right to challenge the accuracy
and pertinence of the cited references.
[0058] These and other modifications and variations to the present
invention may be practiced by those of ordinary skill in the art,
without departing from the spirit and scope of the present
invention, which is more particularly set forth in the appended
claims. In addition, it should be understood that aspects of the
various embodiments may be interchanged in whole or in part.
Furthermore, those of ordinary skill in the art will appreciate
that the foregoing description is by way of example only, and is
not intended to limit the invention so further described in such
appended claims. Therefore, the spirit and scope of the appended
claims should not be limited to the description of the preferred
versions contained therein.
* * * * *