U.S. patent application number 15/960674 was filed with the patent office on 2018-08-23 for nutritional compositions containing structured fat globules and uses thereof.
The applicant listed for this patent is Mead Johnson Nutrition Company. Invention is credited to John Alvey, Dattatreya Banavara.
Application Number | 20180235269 15/960674 |
Document ID | / |
Family ID | 50159591 |
Filed Date | 2018-08-23 |
United States Patent
Application |
20180235269 |
Kind Code |
A1 |
Banavara; Dattatreya ; et
al. |
August 23, 2018 |
Nutritional Compositions Containing Structured Fat Globules And
Uses Thereof
Abstract
The present disclosure relates to a lipid source for nutritional
compositions, comprising an enriched lipid fraction which comprises
structured fat globules. The enriched lipid fraction provides fat
globules having a desired size and fatty acid composition and may
be stabilized by components such as phospholipids, cholesterol,
milk-fat globule membrane protein and combinations thereof.
Additionally, the disclosure relates to methods of supporting lipid
digestion in a pediatric subject by providing a nutritional
composition comprising an enriched lipid fraction having structured
fat globules that are more accessible to lipases. The chemical
composition, size and structure of the fat globules may improve
digestion. The disclosed nutritional compositions may provide
additive and or/synergistic beneficial health effects.
Inventors: |
Banavara; Dattatreya;
(Newburgh, IN) ; Alvey; John; (Evansville,
IN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Mead Johnson Nutrition Company |
Chicago |
IL |
US |
|
|
Family ID: |
50159591 |
Appl. No.: |
15/960674 |
Filed: |
April 24, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13794270 |
Mar 11, 2013 |
9980506 |
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15960674 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A23V 2002/00 20130101;
A23L 33/40 20160801; A23L 33/12 20160801; A23L 33/135 20160801;
A23L 33/19 20160801; A23L 33/115 20160801; A23C 9/14 20130101; A23V
2002/00 20130101; A23V 2250/1578 20130101; A23V 2250/1588 20130101;
A23V 2250/1592 20130101; A23V 2250/1598 20130101; A23V 2250/16
20130101; A23V 2250/161 20130101; A23V 2250/1612 20130101; A23V
2250/1614 20130101; A23V 2250/1618 20130101; A23V 2250/1642
20130101; A23V 2250/1842 20130101; A23V 2250/1866 20130101; A23V
2250/1868 20130101; A23V 2250/1876 20130101; A23V 2250/1882
20130101; A23V 2250/194 20130101; A23V 2250/28 20130101; A23V
2250/304 20130101; A23V 2250/54252 20130101; A23V 2250/612
20130101; A23V 2250/702 20130101; A23V 2250/7042 20130101; A23V
2250/7044 20130101; A23V 2250/7046 20130101; A23V 2250/7052
20130101; A23V 2250/7056 20130101; A23V 2250/706 20130101; A23V
2250/708 20130101; A23V 2250/71 20130101; A23V 2250/712 20130101;
A23V 2250/714 20130101; A23V 2250/72 20130101 |
International
Class: |
A23L 33/115 20060101
A23L033/115; A23C 9/14 20060101 A23C009/14; A23L 33/135 20060101
A23L033/135; A23L 33/00 20060101 A23L033/00; A23L 33/19 20060101
A23L033/19; A23L 33/12 20060101 A23L033/12 |
Claims
1. An nutritional composition comprising: a carbohydrate source, a
protein source, and a lipid source comprising milk fat globules
formed from an enriched lipid fraction derived from milk.
2. The nutritional composition of claim 1, wherein the average
diameter of the milk fat globules range is at least about 2
.mu.m.
3. The nutritional composition of claim 2, wherein the average
diameter of the milk fat globules range is in the range of about 2
.mu.m to about 13 .mu.m.
4. The nutritional composition of claim 3, wherein the average
diameter of the milk fat globules range is in the range of about 3
.mu.m to about 6 .mu.m.
5. The nutritional composition of claim 1, wherein the specific
surface area of the milk fat globules range is in the range of
about 0.9 m.sup.2/g to about 3 m.sup.2/g.
6. The nutritional composition of claim 1, wherein the milk fat
globules comprise trans-fatty acids at a level of from about 0.2
g/100 kcal to about 5.2 g/100 kcal; OBCFAs at a level of from about
0.3 g/100 kcal to about 6.1 g/100 kcal; BCFAs at a level of from
about 0.2 g/100 kcal to about 5.4 g/100 kcal; CLA at a level of
from about 0.4 g/100 kcal to about 0.8 g/100 kcal; and cholesterol
at a level of from about 10 mg/100 kcal to about 400 mg/100
kcal.
7. The nutritional composition of claim 1, wherein the milk fat
globules comprise at least one phospholipid.
8. The nutritional composition of claim 1, further comprising
DHA.
9. The nutritional composition of claim 1, further comprising at
least one probiotic.
10. The nutritional composition of claim 1, further comprising at
least one prebiotic.
11. The nutritional composition of claim 1, wherein the nutritional
composition is an infant formula.
12. A nutritional composition, comprising per 100 kcal: (i) between
about 6 g and about 22 g of a carbohydrate source; (ii) between
about 1 g and about 7 g of a protein source; (iii) between about 1
g and about 10.3 g of a lipid source, wherein the lipid source
comprises an enriched lipid fraction derived from milk, the
enriched lipid fraction comprising milk fat globules.
13. A method of promoting lipid digestion in a pediatric subject
comprising providing a nutritional composition comprising a
carbohydrate source, a protein source, and a lipid source, wherein
the lipid source comprises an enriched lipid fraction derived from
milk and produced by a fractionation procedure wherein the enriched
lipid fraction comprises milk fat globules.
14. The method of claim 13, wherein the average diameter of the
milk fat globules range is at least about 2 .mu.m.
15. The method of claim 14, wherein the average diameter of the
milk fat globules range is in the range of about 2 .mu.m to about
13 .mu.m.
16. The method of claim 15, wherein the average diameter of the
milk fat globules range is in the range of about 3 .mu.m to about 6
.mu.m.
17. The method of claim 13, wherein the specific surface area of
the milk fat globules range is in the range of about 0.9 m.sup.2/g
to about 3 m.sup.2/g.
18. The method of claim 13, wherein the milk fat globules comprise
trans-fatty acids at a level of from about 0.2 g/100 kcal to about
5.2 g/100 kcal; OBCFAs at a level of from about 0.3 g/100 kcal to
about 6.1 g/100 kcal; BCFAs at a level of from about 0.2 g/100 kcal
to about 5.4 g/100 kcal; CLA at a level of from about 0.4 g/100
kcal to about 0.8 g/100 kcal; and cholesterol at a level of from
about 10 mg/100 kcal to about 400 mg/100 kcal.
19. The method of claim 13, wherein the milk fat globules comprise
at least one phospholipid.
Description
TECHNICAL FIELD
[0001] The present disclosure relates generally to a lipid source
for nutritional compositions, comprising an enriched lipid fraction
which comprises structured fat globules. The enriched lipid
fraction provides fat globules having a desired size and fatty acid
composition and may be stabilized by components such as
phospholipids, cholesterol, milk-fat globule membrane protein and
combinations thereof. In an embodiment, the fat globules of the
present disclosure are similar in size to naturally occurring milk
fat globules.
[0002] Additionally, the disclosure relates to methods of
supporting lipid digestion in a pediatric subject by providing a
nutritional composition comprising an enriched lipid fraction
having structured fat globules that are more accessible to lipases.
The chemical composition, size and structure of the fat globules
may improve digestion. The disclosed nutritional compositions may
provide additive and or/synergistic beneficial health effects.
BACKGROUND ART
[0003] Lipids constitute a broad group of naturally occurring
molecules that include fats. In addition to fats, lipids may also
include waxes, sterols, fat-soluble vitamins, monoglycerides,
diglycerides, triglycerides, phospholipids, fatty acids,
glycerophospholipids, sphingolipids, saccharolipids, polyketides,
prenol lipids and sterol lipids, for example cholesterol. Lipids
are vital components of cell membranes and have several forms and
functions, are involved in many metabolic processes and are one of
the major multifunctional agents present in human milk. Lipids also
provide a form of energy storage and act as vehicles for absorption
and transport of fat-soluble vitamins.
[0004] Fats are a subgroup of lipids generally referred to as
triglycerides; they are a concentrated source of energy that can
provide over 30% and up to 70% or more of dietary calories. Fat
facilitates the absorption of fat-soluble vitamins and supplies
essential fatty acids.
[0005] Milk, such as bovine milk, is a complex emulsion that
contains several classes of components, including lipids and fats,
which fulfill nutritional requirements and/or deliver special
health benefits to the consumer. The fat component of milk exists
in the form of globules which have a diameter which ranges in size
from 0.1 to 20 micrometers. The presence of fat globules and the
size and composition of the fat globules in milk contribute to the
nutritional properties and other characteristics of milk.
[0006] The fat globules in milk comprise about 98% triacylglycerols
("TAGs") and are stabilized by a cellular milk fat globule membrane
("MFGM"). Structurally, TAGs are derived from glycerol and include
three fatty acid moieties. Upon digestion the fatty acids attached
to the glycerol backbone are cleaved by digestional lipases and
used by the body as nutrients. Accordingly, TAGs are the major
storage form of energy in animals.
[0007] Milk may contain a variety of fatty acids, either as free
fatty acids or as part of a TAG. For example milk fat may comprise
saturated fatty acids, trans-fatty acids, monounsaturated fatty
acids, polyunsaturated fatty acids, odd-and branched chain fatty
acids ("OBCFAs"), branched chain fatty acids ("BCFAs") and/or
conjugated linoleic acid ("CLA").
[0008] MFGM is the membrane surrounding the lipid droplets, which
includes the fatty acids and TAGs, found in milk. MFGM consists of
a complex mixture of phospholipids, proteins, glycoproteins,
triglycerides, cholesterol, enzymes and other minor components. The
chemical composition of MFGM is close to that of a cell membrane,
typically having a bilayer composed of fatty acids and/or
phospholipids. In bovine milk, the MFGM accounts for 2-6% of the
mass of the milk fat globules.
[0009] One important property of milk fat globules is their size,
both in terms of the average size of the total fat globules found
in milk and the range or distribution of the fat globule sizes
found in milk. In naturally occurring milk fat globules, the size
of the globule can cause variations in the actual fatty acid
composition of the triacyglcerols of the globule. For example,
smaller milk fat globules contain more C.sub.18:0 and more
C.sub.18:1 fatty acids than do larger milk fat globules.
[0010] Particularly with respect to human milk, the size of the fat
globules vary with time postpartum, and are generally in the range
of about 2.5 .mu.m to about 5.0 .mu.m, volume-surface average
diameter, or from about 3.0 .mu.m to about 6.0 .mu.m, volumic
average diameter. The specific surface area of human milk is,
generally speaking, between about 1.0 m.sup.2/g and about 2.0
m.sup.2/g, and the mean free distance between fat globules in the
human milk emulsion is understood to be between about 15.sup.5
.mu.m and about 19.sup.5 .mu.m. In the case of human milk,
participation of milk proteins in the MFGM is minimal, with most
milk proteins existing free in the emulsion, rather than forming an
element of the MFGM.
[0011] During breastfeeding, the infant's suckling action produces
lingual lipases in the mouth; these lingual lipases are active at a
lower pH than pancreatic lipases. The phospholipid layer
surrounding the human milk fat globules is relatively porous, and
gets exposed to the lingual lipases in the stomach, which leads to
release of free and monoacylglycerols of C8, C10, C12 and C14 fatty
acids. These fatty acids have an antiviral and antibacterial
effect, which help protect the infant. Moreover, the presence of
lingual lipases facilitates the rapid digestion of fat in the
infant's stomach, especially since bile salt dependent lipase
("BSDL") and co-lipase dependent lipase ("CDL"), two of the other
primary mechanisms of fat digestion in humans, are present at
relatively low levels in infants.
[0012] While the size of fat globules in bovine milk is comparable
to human milk, the situation changes when the bovine milk is
homogenized. Homogenization of bovine milk can break the MFGM
and/or increase the surface area of the globules by decreasing the
fat globule size to less than 2 .mu.m (volume-surface average
diameter) or less than 3 .mu.m (volumic average diameter). Casein
micelles surround the membrane after homogenization and, when
pasteurized, whey proteins are denatured and whey and casein
surround the bovine milk fat globules, with MFGM components like
phospholipids pushed to the aqueous medium.
[0013] With respect to commercially available pediatric nutritional
compositions like infant formulas, many contain a lipid source from
vegetable oils stabilized by added proteins and/or emulsifiers,
with a globule size of less than 1.6 .mu.m (volume-surface average
diameter) or 2.2 .mu.m (volumetric average diameter). The specific
surface area of the infant formula fat globules is believed to be
above 5.0 m.sup.2/g, and often significantly above 5.0 m.sup.2/g.
These infant formula fat globules often have a dense cloud of
denatured proteins surrounding the globule. Thus, the proteins need
to be digested by gastric proteases before the globules can be
accessed by lipases for lipid digestion. And, the relatively small
globule size and higher surface area requires more proteases at a
lower pH than larger globules would.
[0014] Moreover, the lipid source provided by vegetable oils lacks
certain components of milk fat or milk fat globule membrane that
are known to play an important role in pediatric and/or infant
health and development. Replacing milk fat in nutritional
compositions, such as infant formula, with vegetable oils may have
other draw-backs, including non-reversible component interactions
between proteins, lipids and minerals found in the nutritional
compositions.
[0015] Therefore, pediatric subjects who consume infant formulas or
pediatric nutritional compositions that have a fat source
stabilized by added proteins may not be receiving adequate lipid
nutrition.
[0016] Accordingly, it would be beneficial to provide a nutritional
composition having an enriched lipid fraction that includes fat
globules that are similar in size and composition to human milk fat
globules. Additionally, since naturally occurring fat globule size
can affect fatty acid composition of the milk fat globules, it
would be beneficial to provide enriched lipid fractions that
include milk fat globules of a desired size and fatty acid
composition.
[0017] Further, it would be beneficial to provide milk fat globules
that are stabilized by components similar to those found in the
human milk, such as phospholipids, cholesterol and milk fat globule
membrane proteins, instead of other added proteins and emulsifiers.
Additionally, it is beneficial to provide a method of promoting
digestion in a pediatric subject by providing a nutritional
composition that contains a lipid source comprising an enriched
lipid fraction having milk fat globules similar in chemical
composition and size to those found in human milk.
BRIEF SUMMARY
[0018] Briefly, the present disclosure is directed, in an
embodiment, to a nutritional composition that contains a
carbohydrate source, a protein source and a lipid source comprised
of an enriched lipid fraction derived from milk, and that comprises
milk fat globules.
[0019] In some embodiments, the milk fat globules may include
saturated fatty acids, trans-fatty acids, monounsaturated fatty
acids, polyunsaturated fatty acids, cholesterol, odd-and branched
chain fatty acids ("OBCFAs"), branched chain fatty acids ("BCFAs"),
conjugated linoleic acid ("CLA"), phospholipids, or milk fat
globule membrane protein, and mixtures thereof.
[0020] The enriched lipid fraction, and milk fat globules contained
therein, may be used as the sole fat source in a nutritional
composition or may be used in combination with other fat sources
including, but not limited to, a vegetable fat source.
[0021] In one embodiment, the nutritional composition containing
the milk fat globules may be an infant formula. The addition of the
milk fat globules provides an enriched fat and lipid source to the
infant that may be more fully digested by a pediatric subject.
[0022] In certain embodiments the nutritional composition may
optionally contain at least one prebiotic, at least one probiotic,
a source of long chain polyunsaturated fatty acids ("LCPUFAs"), for
example docosahexaenoic acid ("DHA") and/or arachidonic acid
("ARA"), .beta.-glucan, a source of iron, and mixtures of one or
more thereof.
[0023] Additionally, the disclosure is directed to a method of
promoting lipid digestion in a pediatric subject by providing a
nutritional composition that includes milk fat globules.
[0024] It is to be understood that both the foregoing general
description and the following detailed description present
embodiments of the disclosure and are intended to provide an
overview or framework for understanding the nature and character of
the disclosure as it is claimed. The description serves to explain
the principles and operations of the claimed subject matter. Other
and further features and advantages of the present disclosure will
be readily apparent to those skilled in the art upon a reading of
the following disclosure.
DETAILED DESCRIPTION
[0025] Reference now will be made in detail to the embodiments of
the present disclosure, one or more examples of which are set forth
herein below. Each example is provided by way of explanation of the
nutritional composition of the present disclosure and is not a
limitation. In fact, it will be apparent to those skilled in the
art that various modifications and variations can be made to the
teachings of the present disclosure without departing from the
scope of the disclosure. For instance, features illustrated or
described as part of one embodiment, can be used with another
embodiment to yield a still further embodiment.
[0026] Thus, it is intended that the present disclosure 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 disclosure are disclosed in or are apparent
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 disclosure.
[0027] The present disclosure relates generally to a fat source for
nutritional compositions, the fat source containing milk fat
globules derived from milk. Additionally, the disclosure relates to
methods of promoting lipid digestion in a pediatric subject by
providing a nutritional composition comprising a fat source that
includes milk fat globules.
[0028] "Nutritional composition" means a substance or formulation
that satisfies at least a portion of a subject's nutrient
requirements. The terms "nutritional(s)", "nutritional formula(s)",
"enteral nutritional(s)", and "nutritional supplement(s)" are used
as non-limiting examples of nutritional composition(s) throughout
the present disclosure. Moreover, "nutritional composition(s)" may
refer to liquids, powders, gels, pastes, solids, concentrates,
suspensions, or ready-to-use forms of enteral formulas, oral
formulas, formulas for infants, formulas for pediatric subjects,
formulas for children, growing-up milks and/or formulas for
adults.
[0029] "Pediatric subject" means a human less than 13 years of age.
In some embodiments, a pediatric subject refers to a human subject
that is between birth and 8 years old. In other embodiments, a
pediatric subject refers to a human subject between 1 and 6 years
of age. In still further embodiments, a pediatric subject refers to
a human subject between 6 and 12 years of age. The term "pediatric
subject" may refer to infants (preterm or full term) and/or
children, as described below.
[0030] "Infant" means a human subject ranging in age from birth to
not more than one year and includes infants from 0 to 12 months
corrected age. The phrase "corrected age" means an infant's
chronological age minus the amount of time that the infant was born
premature. Therefore, the corrected age is the age of the infant if
it had been carried to full term. The term infant includes low
birth weight infants, very low birth weight infants, and preterm
infants. "Preterm" means an infant born before the end of the
37.sup.th week of gestation. "Full term" means an infant born after
the end of the 37.sup.th week of gestation.
[0031] "Child" means a subject ranging in age from 12 months to
about 13 years. In some embodiments, a child is a subject between
the ages of 1 and 12 years old. In other embodiments, the terms
"children" or "child" refer to subjects that are between one and
about six years old, or between about seven and about 12 years old.
In other embodiments, the terms "children" or "child" refer to any
range of ages between 12 months and about 13 years.
[0032] "Infant formula" means a composition that satisfies at least
a portion of the nutrient requirements of an infant. In the United
States, the content of an infant formula is dictated by the federal
regulations set forth at 21 C.F.R. Sections 100, 106, and 107.
These regulations define macronutrient, vitamin, mineral, and other
ingredient levels in an effort to simulate the nutritional and
other properties of human breast milk.
[0033] "Fractionation procedure" includes any process in which a
certain quantity of a mixture is divided up into a number of
smaller quantities known as fractions. The fractions may be
different in composition from both the mixture and other fractions.
Examples of fractionation procedures include but are not limited
to, melt fractionation, solvent fractionation, supercritical fluid
fractionation and/or combinations thereof.
[0034] The term "growing-up milk" refers to a broad category of
nutritional compositions intended to be used as a part of a diverse
diet in order to support the normal growth and development of a
child between the ages of about 1 and about 6 years of age.
[0035] "Fat globule" refers to a small mass of fat surrounded by
phospholipids and other membrane and/or serum proteins, where the
fat itself can be a combination of any vegetable or animal fat.
[0036] "Milk" means a component that has been drawn or extracted
from the mammary gland of a mammal. In some embodiments, the
nutritional composition comprises components of milk that are
derived from domesticated ungulates, ruminants or other mammals or
any combination thereof.
[0037] "Nutritionally complete" means a composition that may be
used as the sole source of nutrition, which would supply
essentially all of the required daily amounts of vitamins,
minerals, and/or trace elements in combination with proteins,
carbohydrates, and lipids. Indeed, "nutritionally complete"
describes a nutritional composition that provides adequate amounts
of carbohydrates, lipids, essential fatty acids, proteins,
essential amino acids, conditionally essential amino acids,
vitamins, minerals and energy required to support normal growth and
development of a subject.
[0038] A nutritional composition that is "nutritionally complete"
for a full term infant will, by definition, provide qualitatively
and quantitatively adequate amounts of all carbohydrates, lipids,
essential fatty acids, proteins, essential amino acids,
conditionally essential amino acids, vitamins, minerals, and energy
required for growth of the full term infant.
[0039] A nutritional composition that is "nutritionally complete"
for a child will, by definition, provide qualitatively and
quantitatively adequate amounts of all carbohydrates, lipids,
essential fatty acids, proteins, essential amino acids,
conditionally essential amino acids, vitamins, minerals, and energy
required for growth of a child.
[0040] "Branched Chain Fatty Acid" ("BCFA") means a fatty acid
containing a carbon constituent branched off the carbon chain.
Typically the branch is an alkyl branch, especially a methyl group,
but ethyl and propyl branches are also known. The addition of the
methyl branch lowers the melting point compared with the equivalent
straight chain fatty acid. This includes branched chain fatty acids
with an even number of carbon atoms in the carbon chain. Examples
of these can be isomers of tetradecanoic acid, hexadecanoic
acid.
[0041] "Odd- and Branched-Chain Fatty Acid" ("OBCFA") is a subset
of BCFA that has an odd number of carbon atoms and have one or more
alkyl branches on the carbon chain. The main odd- and
branched-chain fatty acids found in bovine milk include, but are
not limited to, the isomers of tetradecanoic acid, pentadecanoic
acid, hexadecanoic acid, and heptadecanoic acid. For the purposes
of this disclosure, the term "BCFA" includes both branched-chain
fatty acids and odd-and-branched chain fatty acids.
[0042] "Trans-fatty acid" means an unsaturated fat with a
trans-isomer. Trans-fats may be monounsaturated or polyunsaturated.
Trans refers to the arrangement of the two hydrogen atoms bonded to
the carbon atoms involved in a double bond. In the trans
arrangement, the hydrogens are on opposite sides of the bond. Thus
a trans-fatty acid is a lipid molecule that contains one or more
double bonds in trans geometric configuration.
[0043] "Phospholipids" means an organic molecule that contains a
diglyceride, a phosphate group and a simple organic molecule.
Examples of phospholipids include but are not limited to,
phosphatidic acid, phosphatidylethanolamine, phosphatidylcholine,
phosphatidylserine, phsphatidylinositol, phosphatidylinositol
phosphate, phosphatidylinositol biphosphate and
phosphatidylinositol triphosphate, ceramide phosphorylcholine,
ceramide phosphorylethanolamine and ceramide phosphorylglycerol.
This definition further includes sphigolipids, glycolipids, and
gangliosides.
[0044] The nutritional composition of the present disclosure may be
substantially free of any optional or selected ingredients
described herein, provided that the remaining nutritional
composition still contains all of the required ingredients or
features described herein. In this context, and unless otherwise
specified, the term "substantially free" means that the selected
composition may contain less than a functional amount of the
optional ingredient, typically less than 0.1% by weight, and also,
including zero percent by weight of such optional or selected
ingredient.
[0045] All percentages, parts and ratios as used herein are by
weight of the total composition, unless otherwise specified.
[0046] All references to singular characteristics or limitations of
the present disclosure shall include the corresponding plural
characteristic or limitation, and vice versa, unless otherwise
specified or clearly implied to the contrary by the context in
which the reference is made.
[0047] All combinations of method or process steps as used herein
can be performed in any order, unless otherwise specified or
clearly implied to the contrary by the context in which the
referenced combination is made.
[0048] The methods and compositions of the present disclosure,
including components thereof, can comprise, consist of, or consist
essentially of the essential elements and limitations of the
embodiments described herein, as well as any additional or optional
ingredients, components or limitations described herein or
otherwise useful in nutritional compositions.
[0049] As used herein, the term "about" should be construed to
refer to both of the numbers specified as the endpoint(s) of any
range. Any reference to a range should be considered as providing
support for any subset within that range.
[0050] The present disclosure is directed to nutritional
compositions containing a carbohydrate source, a protein source,
and a fat source wherein the fat source comprises milk fat
globules. In some embodiments the milk fat globules may include
saturated fatty acids, trans-fatty acids, monounsaturated fatty
acids, polyunsaturated fatty acids, OBCFAs, BCFAs, CLA,
cholesterol, phospholipids, or milk fat globule membrane proteins,
and mixtures of two or more thereof.
[0051] The milk fat globules may have an average diameter
(volume-surface area average diameter) of at least about 2 .mu.m.
In some embodiments, the average diameter is in the range of from
about 2 .mu.m to about 13 .mu.m. In other embodiments, the milk fat
globules may range from about 2.5 .mu.m to about 10 .mu.m. Still in
other embodiments, the milk fat globules may range in average
diameter from about 3 .mu.m to about 6 .mu.m. The specific surface
area of the globules is, in certain embodiments, less than 3.5
m.sup.2/g, and in other embodiments is between about 0.9 m.sup.2/g
to about 3 m.sup.2/g. The desired milk fat globule size may be
formulated to be comparable to milk fat globules found in human
breast milk. Without being bound by any particular theory, it is
believed that milk fat globules of the aforementioned sizes are
more accessible to lipases therefore leading to better digestion
lipid digestion.
[0052] In some embodiments where the milk fat globules contain
saturated fatty acids, the saturated fatty acids may be present in
a concentration from about 0.1 g/100 kcal to about 8.0 g/100 kcal.
In certain embodiments the saturated fatty acids may be present
from about 0.5 g/100 kcal to about 2.0 g/100 kcal. In still other
embodiments the saturated fatty acids may be present from about 3.5
g/100 kcal to about 6.9 g/100 kcal.
[0053] Examples of saturated fatty acids suitable for inclusion in
the milk fat globules include, but are not limited to, butyric,
valeric, caproic, caprylic, decanoic, lauric, myristic, palmitic,
steraic, arachidic, behenic, alignoceric, tetradecanoic,
hexadecanoic, palmitic, and octadecanoic acid, and/or combinations
and mixtures thereof.
[0054] Additionally, the milk fat globules may comprise, in some
embodiments, lauric acid. Lauric acid, also known as dodecanoic
acid, is a saturated fatty acid with a 12-carbon atom chain and is
believed to be one of the main antiviral and antibacterial
substances currently found in human breast milk. The milk fat
globules may be enriched with triglycerides containing lauric acid
at either the Sn-1, Sn-2 and/or Sn-3 positions. Without being bound
by any particular theory, it is believed that when the enriched
lipid fraction is ingested, the mouth lingual lipase and pancreatic
lipase will hydrolyze the triglycerides to a mixture of glycerides
including mono-lauric and free lauric acid.
[0055] The concentration of lauric acid in the globules varies from
80 mg/100 ml to 800 mg/100 ml. The concentration of monolauryl n
the globules can be in the range of 20 mg/100 ml to 300 mg/100 ml
feed. In some embodiments, the range is 60 mg/100 ml to 130 mg/100
ml
[0056] The milk fat globules may contain trans-fatty acids in
certain embodiments. The trans-fatty acids included in the milk fat
globules may be monounsaturated or polyunsaturated trans-fatty
acids. In some embodiments the trans-fatty acids may be present in
an amount from about 0.2 g/100 kcal to about 7.0 g/100 kcal. In
other embodiments the trans-fatty acids may be present in an amount
from about 3.4 g/100 kcal to about 5.2 g/100 kcal. In yet other
embodiments the trans-fatty acids may be present from about 1.2
g/100 kcal to about 4.3 g/100 kcal.
[0057] Examples of trans-fatty acids for inclusion in the milk fat
globules include, but are not limited to, vaccenic, or elaidic
acid, and mixtures thererof. Moreover, when consumed, mammals
convert vaccenic acid into rumenic acid, which is a conjugated
linoleic acid that exhibits anticarcinogenic properties.
Additionally, a diet enriched with vaccenic acid may help lower
total cholesterol, LDL cholesterol and triglyceride levels.
[0058] In some embodiments where the milk fat globules contain
OBCFAs, these OBCFAs may be present in an amount from about 0.3
g/100 kcal to about 6.1 g/100 kcal. In other embodiments OBCFAs may
be present in an amount from about 2.2 g/100 kcal to about 4.3
g/100 kcal. In yet another embodiment OBCFAs may be present in an
amount from about 3.5 g/100 kcal to about 5.7 g/100 kcal. In still
other embodiments, the milk fat globules comprise at least one
OBCFA.
[0059] Typically, an infant may absorb OBCFAs while in utero and
from the breast milk of a nursing mother. Therefore, OBCFAs that
are identified in human milk are preferred for inclusion in the
milk fat globules of the nutritional composition. Addition of
OBCFAs to infant or children's formulas allows such formulas to
mirror the composition and functionality of human milk and to
promote general health and well-being.
[0060] In some embodiments, the milk fat globules may comprise
BCFAs. In some embodiments the BCFAs are present at a concentration
from about 0.2 g/100 kcal and about 5.82 g/100 kcal. In another
embodiment, the milk fat globules contain BCFAs from about 2.3
g/100 kcal to about 4.2 g/100 kcal. In yet another embodiment the
milk fat globules contain BCFAs from about 4.2 g/100 kcal to about
5.82 g/100 kcal. In still other embodiments, the milk fat globules
comprise at least one BCFA.
[0061] BCFAs that are identified in human milk are preferred for
inclusion in the nutritional composition. Addition of BCFAs to
infant or children's formulas allows such formulas to mirror the
composition and functionality of human milk and to promote general
health and well-being.
[0062] In certain embodiments the milk fat globules may comprise
CLA. In some embodiments CLA may be present in a concentration from
about 0.4 g/100 kcal to about 2.5 g/100 kcal. In other embodiments
CLA may be present from about 0.8 g/100 kcal to about 1.2 g/100
kcal. In yet other embodiments CLA may be present from about 1.2
g/100 kcal to about 2.3 g/100 kcal. In still other embodiments, the
milk fat globules comprise at least one CLA.
[0063] CLAs that are identified in human milk are preferred for
inclusion in the nutritional composition. Typically, CLAs are
absorbed by the infant from the human milk of a nursing mother.
Addition of CLAs to infant or children's formulas allows such
formulas to mirror the composition and functionality of human milk
and to promote general health and well being.
[0064] Examples of CLAs found in the milk fat globules for the
nutritional composition include, but are not limited to, cis-9,
trans-11 CLA, trans-10, cis-12 CLA, cis-9, trans-12 octadecadienoic
acid, and mixtures thereof.
[0065] The milk fat globules of the present disclosure comprise
monounsaturated fatty acids in some embodiments. The milk fat
globules may be formulated to include monounsaturated fatty acids
from about 0.8 g/100 kcal to about 2.5 g/100 kcal. In other
embodiments the milk fat globules may include monounsaturated fatty
acids from about 1.2 g/100 kcal to about 1.8 g/100 kcal.
[0066] Examples of monounsaturated fatty acids suitable for the
milk fat globules include, but are not limited to, palmitoleic
acid, cis-vaccenic acid, oleic acid, and mixtures thereof.
[0067] In certain embodiments, the milk fat globules of the present
disclosure comprise polyunsaturated fatty acids from about 2.3
g/100 kcal to about 4.4 g/100 kcal. In other embodiments, the milk
fat globules comprise polyunsaturated fatty acids from about 2.7
g/100 kcal to about 3.5 g/100 kcal. In yet another embodiment, the
milk fat globules comprises polyunsaturated fatty acids from about
2.4 g/100 kcal to about 3.3 g/100 kcal.
[0068] In some embodiments, the milk fat globules of the present
disclosure comprise polyunsaturated fatty acids, such as, for
example linoleic acid, linolenic acid, octadecatrienoic acid,
arachidonic acid (ARA), eicosatetraenoic acid, eicopsapentaenoic
acid (EPA), docosapentaenoic acid (DPA), and docosahexaenoic acid
(DHA). Polyunsaturated fatty acids are the precursors for
prostaglandins and eicosanoids, which are known to provide numerous
health benefits, including, anti-inflammatory response, cholesterol
absorption, and increased bronchial function.
[0069] The milk fat globules of the present disclosure can also
comprise cholesterol in some embodiments from about 100 mg/100 kcal
to about 400 mg/100 kal. In another embodiment, the milk fat
globules may comprise cholesterol from about 200 mg/100 kcal to
about 300 mg/100 kcal. As is similar to human milk and bovine milk,
the cholesterol included in the milk fat globules may be present in
the outer bilayer membrane of the milk fat globule to provide
stability to the globular membrane.
[0070] In some embodiments, the milk fat globules of the present
disclosure comprises phospholipids from about 50 mg/100 kcal to
about 200 mg/100 kcal. In other embodiments, the milk fat globules
of the present disclosure may comprise phospholipids from about 75
mg/100 kcal to about 150 mg/100 kcal. In yet other embodiments, the
milk fat globules comprise phospholipids from about 100 mg/100 kcal
to about 250 mg/100 kcal.
[0071] Phospholipids are found in human milk lipids at levels of
about 20 to 40 mg/dl. In certain embodiments, phospholipids may be
incorporated into the milk fat globules to stabilize the milk fat
globule by providing a phospholipid membrane or bilayer
phospholipid membrane. Therefore, in some embodiments the milk fat
globules may be formulated with higher amounts of phospholipids
than those found in human milk.
[0072] The phospholipid composition of human milk lipids, as the
weight percent of total phospholipids, is phosphatidylcholine("PC")
24.9%, phosphatidylethanolamine ("PE") 27.7%, phosphatidylserine
("PS") 9.3%, phosphatidylinositol ("PI") 5.4%, and sphingomyelin
("SPGM") 32.4%, (Harzer, G. et al., Am. J. Clin. Nutr., Vol. 37,
pp. 612-621 (1983)). Thus in one embodiment, the milk fat globules
comprise one or more of PC, PE, PS, PI, SPGM, and mixtures thereof.
Further, the phospholipid composition included in the milk fat
globules may be formulated to provide certain health benefits by
incorporating desired phospholipids.
[0073] In certain embodiments, the milk fat globules of the present
disclosure comprise milk fat globule membrane protein. In some
embodiments, the milk fat globule membrane protein is present from
about 50 mg/100 kcal to about 500 mg/100 kcal.
[0074] Galactolipids may be included, in some embodiments, in the
milk fat globules of the present disclosure. For purposes of this
disclosure "galactolipids" refer to any glycolipid whose sugar
group is galactose. More specifically, galactolipids differ from
glycosphingolipids in that they do not have nigtrogen in their
composition. Galactolipids play an important role in supporting
brain development and overall neuronal health. Additionally, the
galactolipids, galactocerebroside and sulfatides constitute about
23% and 4% of total myelin lipid content respectively, and thus may
be incorporated into the milk fat globules in some embodiments.
[0075] For the purposes of this disclosure, some amounts of the
lipid components of the milk fat globules, such as, saturated fatty
acids, trans-fatty acids, monounsaturated fatty acids,
polyunsaturated fatty acids, OBCFAs, CLA, BCFAs, cholesterol,
phospholipids, and milk fat globule membrane proteins may be
inherently present in known ingredients, such as natural oils or
protein sources, that are commonly used to make nutritional
compositions for pediatric subjects. These inherent lipid
components are not considered part of the lipid component contained
in the milk fat globules described in the present disclosure. The
concentrations and ratios of the lipid components of the milk fat
globules as described herein are calculated based only upon the
lipid components that are present in the milk fat globules of the
present disclosure.
[0076] The enriched lipid fraction derived from milk that includes
the milk fat globules of the present disclosure may be produced by
any number of fractionation techniques. These techniques include
but are not limited to melting point fractionation, organic solvent
fractionation, super critical fluid fractionation, and any variants
and combinations thereof. For example, selected fractions of milk
may be combined to create milk fat globules of desired size and
geometries.
[0077] As noted, melting point fractionation may be used to produce
the milk fat globules of the present disclosure. Generally if the
starting material is high in fat, for example butter, anhydrous
milk fat or butter oil, melting point fractionation is used to
separate the lipid portions based on the melting point of different
triglycerides. Melting point fractionation may be especially useful
for fractionating milk fat since milk triglycerides have a wide
range of melting points.
[0078] In some embodiments, organic solvent fractionation may be
utilized to produce milk fat fraction suitable for formulating the
milk fat globules of the present disclosure. In other embodiments,
supercritical fluid fractionation may also be used to produce milk
fat fractions suitable for formulating the milk fat globules of the
present disclosure. Any organic solvent fractionation procedure or
super critical fractionation procedure well-known in the art may be
used herein to develop the milk fat globules derived from milk.
[0079] Mixtures that may be subjected to the fractionation
procedures to produce the milk fat globules include, but are not
limited to, bovine whole milk, bovine cream, caprine milk, ovine
milk, yak milk and/or mixtures thereof. In a preferred embodiment
the milk mixture used to create the milk fat globules is bovine
milk.
[0080] The following examples introduce milk fat fractions that may
be produced by a fractionation procedure. The milk fat after
fractionation column illustrates milk fat fractions that can be
combined to create milk fat globules, which can be incorporated
into the nutritional composition(s) of the present disclosure.
EXAMPLE 1
[0081] Illustrated below is a lipid profile of fractionated milk
fat (butter, plastic cream) produced by melting point, i.e.
MeltFrac, fractionation procedure.
TABLE-US-00001 Proposed lipid profile of fractionated milk fat
(Using Meltfrac) Milk Fat After Actual fractionation Fatty acid
(g/100 g) (g/100 g) 4:0 4.4 1.0 6:0 2.4 1.0 8:0 1.4 0.5 10:0 2.7
1.5 12:0 3.3 4.0 13:0 0.12 14:0 10.9 12.0 15:0 0.9 16:0 30.6 18.0
17:0 0.4 18:0 12.2 8.0 20:0 0.2 0.1 Saturated fatty acids total
69.52 49.2 10:1 0.3 0.6 14:1 0.8 1.6 16:1 1 17:1 0.2 18:1 22.8
Mono-unsaturated faty acids, cis, total 25.1 40.7 18:2 1.6 3.0 18:3
0.7 1.4 Poly-unsaturated fatty acids, cis, 2.3 4.4 total 16:1t 0.4
0.8 18:1t 2.1 3.0 18:2t 0.2 0.6 Trans fatty acids total 2.7 5.2 CLA
0.4 0.8 Cholesterol mg/100 g 300 400 phospholipids 0.05 0.2 Total
99.6 99.7
EXAMPLE 2
[0082] Illustrated below is a lipid profile of fractionated milk
fat (butter, plastic cream) produced by supercritical extraction
and other solvent techniques.
TABLE-US-00002 Proposed composition of of fractionated milk/cream
fraction (Using supercritical extraction/other Before solvent
techniques) Enrichment After Fatty acid Percent Enrichment 4:0 4.4
2.0 6:0 2.4 2.0 8:0 1.4 2.5 10:0 2.7 4.0 13:0 0.12 12:0 3.3 4.0
14:0 10.9 8.0 15:0 0.9 16:0 30.6 18.0 17:0 0.4 18:0 12.2 6.0 20:0
0.2 0.1 Saturated fatty acids total 69.5 50.7 10:1 0.3 0.6 14:1 0.8
1.6 16:01 1 17:01 0.1 18:01 22.8 30.0 Mono-unsatu-rated faty acids,
cis, 25.0 35.4 total 18:02 1.6 3.0 18:03 0.7 1.4 Poly-unsaturated
fatty acids, cis, total 2.3 4.4 16:1t 0.4 0.4 18:1t 2.1 2.5 18:2t
0.2 0.6 Trans fatty acids total 3.1 4.3 CLA 0.4 0.8 Cholesterol
mg/100 g 300 400 Phospholipids (including 1 3-6 sphingolipids,
glycoplipids, gangliosides) MFGM proteins mg/100 g 100 500 Total
100.9 100.8
[0083] As illustrated by the foregoing examples, different
fractionation procedures will produce fractions of milk that differ
in both fatty acid and lipid composition and concentration. Thus, a
certain fractionation procedure or combination of fractionation
procedures may be utilized to produce lipid fractions with certain
desired fatty acid composition and concentrations. Accordingly, the
lipid fractions having different fatty acid compositions may be
formulated to provide the milk fat globules of the present
disclosure.
EXAMPLE 3
[0084] An analysis was then conducted to determine if the fat
globules produced by the disclosed fractionation process are
comparable to human milk fat globules or conventional infant
formula globules.
[0085] Commercial infant formula, Enfamil Newborn (available from
Mead Johnson Nutrition Company, Glenview, Ill., U.S.) was used as a
control and reconstituted and the fat globule particle size was
measured (volume-surface average diameter) as having a mean of
1.555 .mu.m and a median of 0.962 .mu.m, with a mean to median
ratio of 1.617. Another sample of Enfamil Newborn was prepared,
this time including fat globules prepared in accordance with this
disclosure in place of some of the fat source, and the fat globule
particle size was measured as having a mean of 3.317 .mu.m and a
median of 2.747 .mu.m.
[0086] Each of the samples was then digested by lipase (pancreatin)
for two hours, and the free fatty acids measured. The control
formula had a mean fat globule size of 20.41 .mu.m and a median of
15.72 .mu.m. The free fatty acid content of the control was
measured as 2.1%. The formula having the fat globules derived from
the fraction of the present disclosure had a mean fat globule size
of 8.549 .mu.m and a median of 3.943 .mu.m after digestion; the
free fatty acid content was measured as 4.1%.
[0087] Thus, the formula with fat globules produced in accordance
with this disclosure had a bigger fat globule size initially, but
the fat globule size was less affected by digestion, showing
minimal participation of proteins at the interface. Moreover,
better digestion by the lipase was seen, as evidenced by the higher
free fatty acid percentage.
[0088] Additionally, certain embodiments of this disclosure are
directed toward a method for providing lipid fractions derived from
milk that may be combined to produce certain milk fat globules of a
desired shape, size and/or lipid composition.
[0089] Milk fractions produced after a fractionation procedure,
such as the ones identified in Examples 1-2, may be selected and
combined to create the milk fat globules. For example, milk
fractions with differing lipid concentrations and compositions may
be combined to formulate milk fat globules with a desired lipid
composition or size. In certain geographical regions it may be
desirable to have certain levels of one or more of the milk fat
components to meet nutritional requirements for a pediatric subject
in that region; those levels may differ from region to region.
[0090] Once the desired milk fat globules are obtained, they may be
incorporated into the nutritional composition(s) described herein
by any method well-known in the art. In some embodiments, the milk
fat globules may be substituted for other oils that are normally
included in the fat source of the nutritional composition. For
example, the milk fat globules may be substituted for vegetable
oils, such as palm olein, soy, coconut, and high oleic sunflower
oils.
[0091] In some embodiments, the milk fat globules may be added to
the nutritional composition by replacing an equivalent amount of
the rest of the overall fat blend normally present in the
nutritional composition. In some embodiments, a certain amount of
oil used as a fat source, that does not contain the milk fat
globules described herein may be substituted with milk fat
globules. In yet another embodiment, the nutritional composition
may be supplemented with the milk fat globules. In some
embodiments, the milk fat globules may be the sole fat source added
to the nutritional composition.
[0092] In one embodiment, where the nutritional composition is an
infant formula, the milk fat globules derived from milk may be
added to a commercially available infant formula. 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 Nutrition Company, Glenview, Ill., U.S.) may be
supplemented with the milk fat globules derived from milk, and used
in practice of the current disclosure.
[0093] The nutritional composition(s) of the present disclosure may
also comprise a carbohydrate source. Carbohydrate sources can be
any used in the art, e.g., lactose, glucose, fructose, corn syrup
solids, maltodextrins, sucrose, starch, rice syrup solids, and the
like. The amount of carbohydrate in the nutritional composition
typically can vary from between about 5 g and about 25 g/100 kcal.
In some embodiments, the amount of carbohydrate is between about 6
g and about 22 g/100 kcal. In other embodiments, the amount of
carbohydrate is between about 12 g and about 14 g/100 kcal. In some
embodiments, corn syrup solids are preferred. Moreover, hydrolyzed,
partially hydrolyzed, and/or extensively hydrolyzed carbohydrates
may be desirable for inclusion in the nutritional composition due
to their easy digestibility.
[0094] Non-limiting examples of carbohydrate materials suitable for
use herein include hydrolyzed or intact, naturally or chemically
modified, starches sourced from corn, tapioca, rice or potato, in
waxy or non-waxy forms. Non-limiting examples of suitable
carbohydrates include various hydrolyzed starches characterized as
hydrolyzed cornstarch, maltodextrin, maltose, corn syrup, dextrose,
corn syrup solids, glucose, and various other glucose polymers and
combinations thereof. Non-limiting examples of other suitable
carbohydrates include those often referred to as sucrose, lactose,
fructose, high fructose corn syrup, indigestible oligosaccharides
such as fructooligosaccharides and combinations thereof.
[0095] The nutritional composition(s) of the disclosure may also
comprise a protein source. The protein source can be any used in
the art, e.g., nonfat milk, whey protein, casein, soy protein,
hydrolyzed protein, amino acids, and the like. Bovine milk protein
sources useful in practicing the present disclosure include, but
are not limited to, milk protein powders, milk protein
concentrates, milk protein isolates, nonfat milk solids, nonfat
milk, nonfat dry milk, whey protein, whey protein isolates, whey
protein concentrates, sweet whey, acid whey, casein, acid casein,
caseinate (e.g. sodium caseinate, sodium calcium caseinate, calcium
caseinate) and any combinations thereof.
[0096] In one embodiment, the proteins of the nutritional
composition are provided as intact proteins. In other embodiments,
the proteins are provided as a combination of both intact proteins
and partially hydrolyzed proteins, with a degree of hydrolysis of
between about 4% and 10%. In certain other embodiments, the
proteins are more completely hydrolyzed. In still other
embodiments, the protein source comprises amino acids. In yet
another embodiment, the protein source may be supplemented with
glutamine-containing peptides.
[0097] In a particular embodiment of the nutritional composition,
the whey:casein ratio of the protein source is similar to that
found in human breast milk. In an embodiment, the protein source
comprises from about 40% to about 80% whey protein and from about
20% to about 60% casein.
[0098] In some embodiments, the nutritional composition comprises
between about 1 g and about 7 g of a protein source per 100 kcal.
In other embodiments, the nutritional composition comprises between
about 3.5 g and about 4.5 g of protein per 100 kcal.
[0099] In some embodiments, the nutritional composition described
herein comprises a fat source. The milk fat globules described
herein may be the sole fat source or may be used in combination
with any other suitable fat or lipid source for the nutritional
composition as known in the art. Appropriate fat sources include,
but are not limited to, animal sources, e.g., milk fat, butter,
butter fat, egg yolk lipid; marine sources, such as fish oils,
marine oils, single cell oils; vegetable and plant oils, such as
corn oil, canola oil, sunflower oil, soybean oil, palm olein oil,
coconut oil, high oleic sunflower oil, evening primrose oil,
rapeseed oil, olive oil, flaxseed (linseed) oil, cottonseed oil,
high oleic safflower oil, palm stearin, palm kernel oil, wheat germ
oil; medium chain triglyceride oils and emulsions and esters of
fatty acids; and any combinations thereof.
[0100] The disclosed nutritional composition described herein can,
in some embodiments, also comprise a source of prebiotics. The term
"prebiotic" as used herein refers to indigestible food ingredients
which exert health benefits upon the host. Such health benefits may
include, but are not limited to, selective stimulation of the
growth and/or activity of one or a limited number of beneficial gut
bacteria, stimulation of the growth and/or activity of ingested
probiotic microorganisms, selective reduction in gut pathogens, and
favorable influence on gut short chain fatty acid profile. Such
prebiotics may be naturally-occurring, synthetic, or developed
through the genetic manipulation of organisms and/or plants,
whether such new source is now known or developed later. Prebiotics
useful in the present disclosure may include oligosaccharides,
polysaccharides, and other prebiotics that contain fructose,
xylose, soya, galactose, glucose and mannose.
[0101] More specifically, prebiotics useful in the present
disclosure may include polydextrose, polydextrose powder,
lactulose, lactosucrose, raffinose, gluco-oligosaccharide, inulin,
fructo-oligosaccharide, isomalto-oligosaccharide, soybean
oligosaccharides, lactosucrose, xylo-oligosaccharide,
chito-oligosaccharide, manno-oligosaccharide,
aribino-oligosaccharide, siallyl-oligosaccharide,
fuco-oligosaccharide, galacto-oligosaccharide, and
gentio-oligosaccharides. In one preferred embodiment, the prebiotic
comprises galacto-oligosaccharide, polydextrose, or mixtures
thereof.
[0102] The amount of galacto-oligosaccharide in the nutritional
composition may, in an embodiment, be from about 0.1 mg/100 kcal to
about 1.0 mg/100 kcal. In another embodiment, the amount of
galacto-oligosaccharide in the nutritional composition may be from
about 0.1 mg/100 kcal to about 0.5 mg/100 kcal. The amount of
polydextrose in the nutritional composition may, in an embodiment,
be within the range of from about 0.1 mg/100 kcal to about 0.5
mg/100 kcal. In another embodiment, the amount of polydextrose may
be about 0.3 mg/100 kcal. In a particular embodiment,
galacto-oligosaccharide and polydextrose are supplemented into the
nutritional composition in a total amount of about at least about
0.2 mg/100 kcal and can be about 0.2 mg/100 kcal to about 1.5
mg/100 kcal. In some embodiments, the nutritional composition may
comprise galactooligosaccharide and polydextrose in a total amount
of from about 0.6 to about 0.8 mg/100 kcal.
[0103] The disclosed nutritional composition described herein can,
in some embodiments, also comprise a source of probiotic. The term
"probiotic" means a microorganism that exerts beneficial effects on
the health of the host. Any probiotic known in the art may be
acceptable in this embodiment. In a particular embodiment, the
probiotic may be selected from any Lactobacillus species,
Lactobacillus rhamnosus GG (ATCC number 53103), Bifidobacterium
species, Bifidobacterium longum BB536 (BL999, ATCC: BAA-999),
Bifidobacterium longum AH1206 (NCIMB: 41382), Bifidobacterium breve
AH1205 (NCIMB: 41387), Bifidobacterium infantis 35624 (NCIMB:
41003), and Bifidobacterium animalis subsp. lactis BB-12 (DSM No.
10140) or any combination thereof.
[0104] If included, the nutritional composition may comprise
between about 1.times.104 to about 1.5.times.1010 cfu of probiotics
per 100 kcal, more preferably from about 1.times.106 to about
1.times.109 cfu of probiotics per 100 kcal.
[0105] In an embodiment, the probiotic(s) may be viable or
non-viable. As used herein, the term "viable", refers to live
microorganisms. The term "non-viable" or "non-viable probiotic"
means non-living probiotic microorganisms, their cellular
components and/or metabolites thereof. Such non-viable probiotics
may have been heat-killed or otherwise inactivated, but they retain
the ability to favorably influence the health of the host. The
probiotics useful in the present disclosure may be
naturally-occurring, synthetic or developed through the genetic
manipulation of organisms, whether such new source is now known or
later developed.
[0106] In some embodiments the nutritional composition may also
include a source of long chain polyunsaturated fatty acids
(LCPUFAs). In one embodiment the amount of LCPUFA in the
nutritional composition is advantageously at least about 5 mg/100
kcal, and may vary from about 5 mg/100 kcal to about 100 mg/100
kcal, more preferably from about 10 mg/100 kcal to about 50 mg/100
kcal. Non-limiting examples of LCPUFAs include, but are not limited
to, DHA, ARA, linoleic (18:2 n-6), .gamma.-linolenic (18:3 n-6),
dihomo-.gamma.-linolenic (20:3 n-6) acids in the n-6 pathway,
.alpha.-linolenic (18:3 n-3), stearidonic (18:4 n-3),
eicosatetraenoic (20:4 n-3), eicosapentaenoic (20:5 n-3), and
docosapentaenoic (22:6 n-3).
[0107] In some embodiments, the LCPUFA included in the nutritional
composition may comprise DHA. In one embodiment the amount of DHA
in the nutritional composition is advantageously at least about 17
mg/100 kcal, and may vary from about 5 mg/100 kcal to about 75
mg/100 kcal, more preferably from about 10 mg/100 kcal to about 50
mg/100 kcal.
[0108] In another embodiment, especially if the nutritional
composition is an infant formula, the nutritional composition is
supplemented with both DHA and ARA. In this embodiment, the weight
ratio of ARA:DHA may be between about 1:3 and about 9:1. In a
particular embodiment, the ratio of ARA:DHA is from about 1:2 to
about 4:1.
[0109] The DHA and ARA can be in natural form, provided that the
remainder of the LCPUFA source does not result in any substantial
deleterious effect on the infant. Alternatively, the DHA and ARA
can be used in refined form.
[0110] The disclosed nutritional composition described herein can,
in some embodiments, also comprise a source of .beta.-glucan.
Glucans are polysaccharides, specifically polymers of glucose,
which are naturally occurring and may be found in cell walls of
bacteria, yeast, fungi, and plants. Beta glucans (.beta.-glucans)
are themselves a diverse subset of glucose polymers, which are made
up of chains of glucose monomers linked together via beta-type
glycosidic bonds to form complex carbohydrates.
[0111] .beta.-1,3-glucans are carbohydrate polymers purified from,
for example, yeast, mushroom, bacteria, algae, or cereals. (Stone B
A, Clarke A E. Chemistry and Biology of (1-3)-Beta-Glucans.
London:Portland Press Ltd; 1993.) The chemical structure of
.beta.-1,3-glucan depends on the source of the .beta.-1,3-glucan.
Moreover, various physiochemical parameters, such as solubility,
primary structure, molecular weight, and branching, play a role in
biological activities of .beta.-1,3-glucans. (Yadomae T., Structure
and biological activities of fungal beta-1,3-glucans. Yakugaku
Zasshi. 2000; 120:413-431.)
[0112] .beta.-1,3-glucans are naturally occurring polysaccharides,
with or without .beta.-1,6-glucose side chains that are found in
the cell walls of a variety of plants, yeasts, fungi and bacteria.
.beta.-1,3;1,6-glucans are those containing glucose units with
(1,3) links having side chains attached at the (1,6) position(s).
.beta.-1,3;1,6 glucans are a heterogeneous group of glucose
polymers that share structural commonalities, including a backbone
of straight chain glucose units linked by a .beta.-1,3 bond with
.beta.-1,6-linked glucose branches extending from this backbone.
While this is the basic structure for the presently described class
of .beta.-glucans, some variations may exist. For example, certain
yeast .beta.-glucans have additional regions of .beta.(1,3)
branching extending from the .beta.(1,6) branches, which add
further complexity to their respective structures.
[0113] .beta.-glucans derived from baker's yeast, Saccharomyces
cerevisiae, are made up of chains of D-glucose molecules connected
at the 1 and 3 positions, having side chains of glucose attached at
the 1 and 6 positions. Yeast-derived .beta.-glucan is an insoluble,
fiber-like, complex sugar having the general structure of a linear
chain of glucose units with a .beta.-1,3 backbone interspersed with
.beta.-1,6 side chains that are generally 6-8 glucose units in
length. More specifically, .beta.-glucan derived from baker's yeast
is
poly-(1,6)-.beta.-D-glucopyranosyl-(1,3)-.beta.-D-glucopyranose.
[0114] Furthermore, .beta.-glucans are well tolerated and do not
produce or cause excess gas, abdominal distension, bloating or
diarrhea in pediatric subjects. Addition of .beta.-glucan to a
nutritional composition for a pediatric subject, such as an infant
formula, a growing-up milk or another children's nutritional
product, will improve the subject's immune response by increasing
resistance against invading pathogens and therefore maintaining or
improving overall health.
[0115] In some embodiments, the .beta.-glucan is
.beta.-1,3;1,6-glucan. In some embodiments, the
.beta.-1,3;1,6-glucan is derived from baker's yeast. The
nutritional composition may comprise whole glucan particle
.beta.-glucan, particulate .beta.-glucan, PGG-glucan
(poly-1,6-.beta.-D-glucopyranosyl-1,3-.beta.-D-glucopyranose) or
any mixture thereof.
[0116] In some embodiments, the amount of .beta.-glucan in the
nutritional composition is between about 3 mg and about 17 mg per
100 kcal. In another embodiment the amount of .beta.-glucan is
between about 6 mg and about 17 mg per 100 kcal.
[0117] The disclosed nutritional composition described herein, can,
in some embodiments also comprise an effective amount of iron. The
iron may comprise encapsulated iron forms, such as encapsulated
ferrous fumarate or encapsulated ferrous sulfate or less reactive
iron forms, such as ferric pyrophosphate or ferric
orthophosphate.
[0118] One or more vitamins and/or minerals may also be added in to
the nutritional composition in amounts sufficient to supply the
daily nutritional requirements of a subject. It is to be understood
by one of ordinary skill in the art that vitamin and mineral
requirements will vary, for example, based on the age of the child.
For instance, an infant may have different vitamin and mineral
requirements than a child between the ages of one and thirteen
years. Thus, the embodiments are not intended to limit the
nutritional composition to a particular age group but, rather, to
provide a range of acceptable vitamin and mineral components.
[0119] In embodiments providing a nutritional composition for a
child, the composition may optionally include, but is not limited
to, one or more of the following vitamins or derivations thereof:
vitamin B.sub.1 (thiamin, thiamin pyrophosphate, TPP, thiamin
triphosphate, TTP, thiamin hydrochloride, thiamin mononitrate),
vitamin B.sub.2 (riboflavin, flavin mononucleotide, FMN, flavin
adenine dinucleotide, FAD, lactoflavin, ovoflavin), vitamin B.sub.3
(niacin, nicotinic acid, nicotinamide, niacinamide, nicotinamide
adenine dinucleotide, NAD, nicotinic acid mononucleotide, NicMN,
pyridine-3-carboxylic acid), vitamin B.sub.3-precursor tryptophan,
vitamin B.sub.6 (pyridoxine, pyridoxal, pyridoxamine, pyridoxine
hydrochloride), pantothenic acid (pantothenate, panthenol), folate
(folic acid, folacin, pteroylglutamic acid), vitamin B.sub.12
(cobalamin, methylcobalamin, deoxyadenosylcobalamin,
cyanocobalamin, hydroxycobalamin, adenosylcobalamin), biotin,
vitamin C (ascorbic acid), vitamin A (retinol, retinyl acetate,
retinyl palmitate, retinyl esters with other long-chain fatty
acids, retinal, retinoic acid, retinol esters), vitamin D
(calciferol, cholecalciferol, vitamin D.sub.3,
1,25,-dihydroxyvitamin D), vitamin E (.alpha.-tocopherol,
.alpha.-tocopherol acetate, .alpha.-tocopherol succinate,
.alpha.-tocopherol nicotinate, .alpha.-tocopherol), vitamin K
(vitamin K.sub.1, phylloquinone, naphthoquinone, vitamin K.sub.2,
menaquinone-7, vitamin K.sub.3, menaquinone-4, menadione,
menaquinone-8, menaquinone-8H, menaquinone-9, menaquinone-9H,
menaquinone-10, menaquinone-11, menaquinone-12, menaquinone-13),
choline, inositol, .beta.-carotene and any combinations
thereof.
[0120] In embodiments providing a children's nutritional product,
such as a growing-up milk, the composition may optionally include,
but is not limited to, one or more of the following minerals or
derivations thereof: boron, calcium, calcium acetate, calcium
gluconate, calcium chloride, calcium lactate, calcium phosphate,
calcium sulfate, chloride, chromium, chromium chloride, chromium
picolonate, copper, copper sulfate, copper gluconate, cupric
sulfate, fluoride, iron, carbonyl iron, ferric iron, ferrous
fumarate, ferric orthophosphate, iron trituration, polysaccharide
iron, iodide, iodine, magnesium, magnesium carbonate, magnesium
hydroxide, magnesium oxide, magnesium stearate, magnesium sulfate,
manganese, molybdenum, phosphorus, potassium, potassium phosphate,
potassium iodide, potassium chloride, potassium acetate, selenium,
sulfur, sodium, docusate sodium, sodium chloride, sodium selenate,
sodium molybdate, zinc, zinc oxide, zinc sulfate and mixtures
thereof. Non-limiting exemplary derivatives of mineral compounds
include salts, alkaline salts, esters and chelates of any mineral
compound.
[0121] The minerals can be added to growing-up milks or to other
children's nutritional compositions in the form of salts such as
calcium phosphate, calcium glycerol phosphate, sodium citrate,
potassium chloride, potassium phosphate, magnesium phosphate,
ferrous sulfate, zinc sulfate, cupric sulfate, manganese sulfate,
and sodium selenite. Additional vitamins and minerals can be added
as known within the art.
[0122] The nutritional compositions of the present disclosure may
optionally include one or more of the following flavoring agents,
including, but not limited to, flavored extracts, volatile oils,
cocoa or chocolate flavorings, peanut butter flavoring, cookie
crumbs, vanilla or any commercially available flavoring. Examples
of useful flavorings include, but are not limited to, pure anise
extract, imitation banana extract, imitation cherry extract,
chocolate extract, pure lemon extract, pure orange extract, pure
peppermint extract, honey, imitation pineapple extract, imitation
rum extract, imitation strawberry extract, or vanilla extract; or
volatile oils, such as balm oil, bay oil, bergamot oil, cedarwood
oil, cherry oil, cinnamon oil, clove oil, or peppermint oil; peanut
butter, chocolate flavoring, vanilla cookie crumb, butterscotch,
toffee, and mixtures thereof. The amounts of flavoring agent can
vary greatly depending upon the flavoring agent used. The type and
amount of flavoring agent can be selected as is known in the
art.
[0123] The nutritional compositions of the present disclosure may
optionally include one or more emulsifiers that may be added for
stability of the final product. Examples of suitable emulsifiers
include, but are not limited to, lecithin (e.g., from egg or soy),
alpha lactalbumin and/or mono- and di-glycerides, and mixtures
thereof. Other emulsifiers are readily apparent to the skilled
artisan and selection of suitable emulsifier(s) will depend, in
part, upon the formulation and final product.
[0124] The nutritional compositions of the present disclosure may
optionally include one or more preservatives that may also be added
to extend product shelf life. Suitable preservatives include, but
are not limited to, potassium sorbate, sodium sorbate, potassium
benzoate, sodium benzoate, calcium disodium EDTA, and mixtures
thereof.
[0125] The nutritional compositions of the present disclosure may
optionally include one or more stabilizers. Suitable stabilizers
for use in practicing the nutritional composition of the present
disclosure include, but are not limited to, gum arabic, gum ghatti,
gum karaya, gum tragacanth, agar, furcellaran, guar gum, gellan
gum, locust bean gum, pectin, low methoxyl pectin, gelatin,
microcrystalline cellulose, CMC (sodium carboxymethylcellulose),
methylcellulose hydroxypropyl methyl cellulose, hydroxypropyl
cellulose, DATEM (diacetyl tartaric acid esters of mono- and
diglycerides), dextran, carrageenans, and mixtures thereof.
[0126] The nutritional compositions of the disclosure may provide
minimal, partial or total nutritional support. The compositions may
be nutritional supplements or meal replacements. The compositions
may, but need not, be nutritionally complete. In an embodiment, the
nutritional composition of the disclosure is nutritionally complete
and contains suitable types and amounts of lipid, carbohydrate,
protein, vitamins and minerals. The amount of lipid or fat
typically can vary from about 1 to about 25 g/100 kcal. The amount
of protein typically can vary from about 1 to about 7 g/100 kcal.
The amount of carbohydrate typically can vary from about 6 to about
22 g/100 kcal.
[0127] In an embodiment, the children's nutritional composition may
contain between about 10 and about 50% of the maximum dietary
recommendation for any given country, or between about 10 and about
50% of the average dietary recommendation for a group of countries,
per serving of vitamins A, C, and E, zinc, iron, iodine, selenium,
and choline. In another embodiment, the children's nutritional
composition may supply about 10-30% of the maximum dietary
recommendation for any given country, or about 10-30% of the
average dietary recommendation for a group of countries, per
serving of B-vitamins. In yet another embodiment, the levels of
vitamin D, calcium, magnesium, phosphorus, and potassium in the
children's nutritional product may correspond with the average
levels found in milk. In other embodiments, other nutrients in the
children's nutritional composition may be present at about 20% of
the maximum dietary recommendation for any given country, or about
20% of the average dietary recommendation for a group of countries,
per serving.
[0128] In some embodiments the nutritional composition is an infant
formula. Infant formulas are fortified nutritional compositions for
an infant. The content of an infant formula is dictated by federal
regulations, which define macronutrient, vitamin, mineral, and
other ingredient levels in an effort to simulate the nutritional
and other properties of human breast milk. Infant formulas are
designed to support overall health and development in a pediatric
human subject, such as an infant or a child.
[0129] In some embodiments, the nutritional composition of the
present disclosure is a growing-up milk. Growing-up milks are
fortified milk-based beverages intended for children over 1 year of
age (typically from 1-3 years of age, from 4-6 years of age or from
1-6 years of age). They are not medical foods and are not intended
as a meal replacement or a supplement to address a particular
nutritional deficiency. Instead, growing-up milks are designed with
the intent to serve as a complement to a diverse diet to provide
additional insurance that a child achieves continual, daily intake
of all essential vitamins and minerals, macronutrients plus
additional functional dietary components, such as non-essential
nutrients that have purported health-promoting properties.
[0130] The exact composition of a growing-up milk or other
nutritional composition according to the present disclosure can
vary from market-to-market, depending on local regulations and
dietary intake information of the population of interest. In some
embodiments, nutritional compositions according to the disclosure
consist of a milk protein source, such as whole or skim milk, plus
added sugar and sweeteners to achieve desired sensory properties,
and added vitamins and minerals. The fat composition includes milk
fat globules derived from milk. Total protein can be targeted to
match that of human milk, cow milk or a lower value. Total
carbohydrate is usually targeted to provide as little added sugar,
such as sucrose or fructose, as possible to achieve an acceptable
taste. Typically, Vitamin A, calcium and Vitamin D are added at
levels to match the nutrient contribution of regional cow milk.
Otherwise, in some embodiments, vitamins and minerals can be added
at levels that provide approximately 20% of the dietary reference
intake (DRI) or 20% of the Daily Value (DV) per serving. Moreover,
nutrient values can vary between markets depending on the
identified nutritional needs of the intended population, raw
material contributions and regional regulations.
[0131] The disclosed nutritional composition(s) may be provided in
any form known in the art, such as a powder, a gel, a suspension, a
paste, a solid, a liquid, a liquid concentrate, a reconstituteable
powdered milk substitute or a ready-to-use product. The nutritional
composition may, in certain embodiments, comprise a nutritional
supplement, children's nutritional product, infant formula, human
milk fortifier, growing-up milk or any other nutritional
composition designed for an infant or a pediatric subject.
Nutritional compositions of the present disclosure include, for
example, orally-ingestible, health-promoting substances including,
for example, foods, beverages, tablets, capsules and powders.
Moreover, the nutritional composition of the present disclosure may
be standardized to a specific caloric content, it may be provided
as a ready-to-use product, or it may be provided in a concentrated
form. In some embodiments, the nutritional composition is in powder
form with a particle size in the range of 5 .mu.m to 1500 .mu.m,
more preferably in the range of 10 .mu.m to 300 .mu.m.
[0132] In some embodiments, the disclosure is directed to a method
for promoting lipid digestion in a pediatric subject, the method
comprising providing to the pediatric subject a nutritional
composition comprising a carbohydrate source, a protein source, and
a fat source comprising milk fat globules.
[0133] In some embodiments, providing the pediatric subject a
nutritional composition comprising a fat source with the milk fat
globules described herein will aid in protein digestion. Without
being bound by any particular theory, it is believed that the
proteins will not surround and encapsulate the milk fat globules,
since the globules may be stabilized with other components, such as
phospholipids. Accordingly, there will be fewer proteins at the
interface between the lipid molecules and water, which allow for
easier access to protein molecules by digestional proteases.
[0134] Additionally, the inclusion of the milk fat globules
described herein in the nutritional composition may aid in the
release of DHA, ARA and other fatty acids as well as fat soluble
nutrients included in the nutritional composition. The milk fat
globules are more easily accessible by digestional lipases, which
facilitate the release of DHA, ARA and other fatty acids contained
within the milk fat globules.
[0135] Additionally, in some embodiments of the method described
herein, the nutritional composition provided is an infant formula
comprising milk fat globules derived from milk.
[0136] All combinations of method or process steps as used herein
can be performed in any order, unless otherwise specified or
clearly implied to the contrary by the context in which the
referenced combination is made.
[0137] The methods and compositions of the present disclosure,
including components thereof, can comprise, consist of, or consist
essentially of the essential elements and limitations of the
embodiments described herein, as well as any additional or optional
ingredients, components or limitations described herein or
otherwise useful in nutritional compositions.
[0138] Formulation examples are provided to illustrate some
embodiments of the nutritional composition of the present
disclosure but should not be interpreted as any limitation thereon.
Other embodiments within the scope of the claims herein will be
apparent to one skilled in the art from the consideration of the
specification or practice of the nutritional composition or methods
disclosed herein. It is intended that the specification, together
with the example, be considered to be exemplary only, with the
scope and spirit of the disclosure being indicated by the claims
which follow the example.
FORMULATION EXAMPLES
Table 1
[0139] Table 1, illustrated below, provides an example embodiment
of the nutritional profile of an enriched lipid fraction of the
present disclosure and describes the amount of each ingredient to
be included per 100 kcal serving of nutritional composition.
TABLE-US-00003 TABLE 1 Nutrition profile of an example enriched
lipid fraction per 100 kcal Nutrient/Lipid Minimum Maximum Total
Lipid Content (g) 1.35 26.3 Saturated fatty acid (g) 0.1 7.2
Trans-fatty acid (g) 0.2 5.2 OBCFAs (g) 0.05 1 CLA(g) 0.05 1 BCFA
(g) 0.05 1 Cholesterol (mg) 100 400 Milk Phospholipids (mg) 50
500
Table 2
[0140] Table 2, shown below, provides an example of a nutritional
composition according to the present disclosure and describes the
amount of each ingredient to be included per 100 kcal serving.
TABLE-US-00004 TABLE 2 Nutrition profile of an example nutritional
composition per 100 kcal Nutrient/Lipid Minimum Maximum Protein (g)
1.2 6.8 Fat total including enriched 1.4 10.3 lipid fraction (g)
Carbohydrates (g) 6 22 Prebiotic (g) 0.3 1.2 DHA (mg) 4 32 Beta
glucan (mg) 2.9 17 Saturated Fatty acids (g) 0.1 2.3 Trans-fatty
acid (g) 0.1 1.2 OBCFAs (g) 0.05 1.0 CLA (g) 0.05 1.0 Cholesterol
(mg) 100 400 Milk Phospholipids (mg) 50 500 Phosphotidylcholine
(mg) 130 400 SphingoMyelin (mg) 5 60 BCFAs (g) 0.3 2.3 Probiotics
(cfu) 9.60 .times. 10.sup.5 3.80 .times. 10.sup.8 Vitamin A (IU)
134 921 Vitamin D (IU) 22 126 Vitamin E (IU) 0.8 5.4 Vitamin K
(mcg) 2.9 18 Thiamin (mcg) 63 328 Riboflavin (mcg) 68 420 Vitamin
B6 (mcg) 52 397 Vitamin B12 (mcg) 0.2 0.9 Niacin (mcg) 690 5881
Folic acid (mcg) 8 66 Panthothenic acid (mcg) 232 1211 Biotin (mcg)
1.4 5.5 Vitamin C (mg) 4.9 24 Choline (mg) 4.9 43 Calcium (mg) 68
297 Phosphorus (mg) 54 210 Magnesium (mg) 4.9 34 Sodium (mg) 24 88
Potassium (mg) 82 346 Chloride (mg) 53 237 Iodine (mcg) 8.9 79 Iron
(mg) 0.7 2.8 Zinc (mg) 0.7 2.4 Manganese (mcg) 7.2 41 Copper (mcg)
16 331
Table 3
[0141] Table 3, provided below, is an example of a nutritional
composition according to the present disclosure and describes the
amount of each ingredient to be included per 100 kcal serving.
TABLE-US-00005 TABLE 3 Nutrition profile of an example nutritional
composition per 100 kcal Nutrient/Lipid Minimum Maximum Protein (g)
1.8 6.8 Carbohydrates (g) 6 22 Fat total including enriched 1.4
10.3 lipid fraction (g) Enriched lipid fraction (g) 0.2 10.3
Prebiotic (g) 0.3 1.2 DHA (mg) 4 32 Beta glucan (mg) 2.9 17
Probiotics (cfu) 9.60 .times. 10.sup.5 3.80 .times. 10.sup.8
Vitamin A (IU) 134 921 Vitamin D (IU) 22 126 Vitamin E (IU) 0.8 5.4
Vitamin K (mcg) 2.9 18 Thiamin (mcg) 63 328 Riboflavin (mcg) 68 420
Vitamin B6 (mcg) 52 397 Vitamin B12 (mcg) 0.2 0.9 Niacin (mcg) 690
5881 Folic acid (mcg) 8 66 Panthothenic acid (mcg) 232 1211 Biotin
(mcg) 1.4 5.5 Vitamin C (mg) 4.9 24 Choline (mg) 4.9 43 Calcium
(mg) 68 297 Phosphorus (mg) 54 210 Magnesium (mg) 4.9 34 Sodium
(mg) 24 88 Potassium (mg) 82 346 Chloride (mg) 53 237 Iodine (mcg)
8.9 79 Iron (mg) 0.7 2.8 Zinc (mg) 0.7 2.4 Manganese (mcg) 7.2 41
Copper (mcg) 16 331
Table 4
[0142] Table 4, provided below, is an example of a nutritional
composition according to the present disclosure and describes the
amount of each ingredient to be included per 100 grams of
nutritional composition.
TABLE-US-00006 TABLE 4 Nutrition profile of an example nutritional
composition Amount INGREDIENT g/100 g Lactose 40.26000 Fat bulk
blend 20.60000 Whey protein concentrate 17.71000 Milk nonfat dry
7.60000 Fractionated milk fat 5.12 Galacto-oligosaccharide 3.67800
Lecithin FCC K 0.79400 Fungal-Algal oil 0.71600 Calcium carbonate
0.45000 Choline chloride PWD 0.17000 Potassium citrate 0.12000
Calcium phosphate 0.11000 Potassium chloride 0.01800 Magnesium
oxide 0.01300 L-carnitine K 0.01100 Sodium Chloride 40-60 MESH
0.00600 Vitamin and Mineral Premix 0.720 Polydextrose powder
1.85000 Nucleotide premix 0.160
[0143] 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, periodicals,
and the like, 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.
[0144] Although embodiments of the disclosure have been described
using specific terms, devices, and methods, such description is for
illustrative purposes only. The words used are words of description
rather than of limitation. It is to be understood that changes and
variations may be made by those of ordinary skill in the art
without departing from the spirit or the scope of the present
disclosure, which is set forth in the following claims. In
addition, it should be understood that aspects of the various
embodiments may be interchanged in whole or in part. Therefore, the
spirit and scope of the appended claims should not be limited to
the description of the versions contained therein.
* * * * *