Abstract: Disclosed embodiments provide low viscosity, high caloric density liquid nutritional compositions. The use of non micellar milk protein in combination with hydrolyzed caseinate and unique formulation methods allow for improved organoleptic qualities and the production of liquid nutritional compositions displaying low viscosity along with a high caloric density.
LOW VISCOSITY, HIGH CALORIC DENSITY ORAL NUTRITIONAL
COMPOSITION AND RELATED METHODS
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to and any benefit of U.S. Provisional Application No. entirety.
61/738,785, filed December 18, 2012, the entire contents of which are incorporated by reference in its
entirety.
TECHNICAL FIELD
[0002] Disclosed embodiments are in the field of nutritional compositions and more particularly
in the field of nutritional compositions displaying high caloric density and low viscosity, and
methods for making same.
BACKGROUND
[0003] Organoleptic characteristics such as mouthfeel play an important role in the selection of
liquid nutritional compositions by consumers. Nutritional compositions having characteristics
such as high protein content, high caloric density, or both may be desirable from a nutritional or
medical standpoint, but often display high viscosity. Highly viscous nutritional compositions are
often perceived as having an unpleasant mouthfeel and as generally undesirable, making the
formulation of high caloric density liquid nutritional compositions in a fashion that is palatable to
a wide variety of consumers very difficult.
SUMMARY
[0004] Provided herein are nutritional compositions that have a relatively low viscosity while
having a high caloric density. Also provided are related methods for formulating the nutritional
compositions. In certain embodiments, the nutritional compositions comprise non-micellar milk
protein and lecithin. Additionally, the nutritional compositions provide at least 8 grams of
protein per 100 mL of composition while achieving a low viscosity {i.e., 45- 140 cps). In certain
embodiments, the nutritional compositions have a high caloric density {i.e., 2-3 kilocalories per
mL).
[0005] In a first embodiment, a low viscosity, high caloric density liquid nutritional composition
is provided. The nutritional composition comprises protein in amount of between 8 to 27 grams
per 100 mL of the nutritional composition, fat in an amount of between 0 and 1 grams per 100
mL of the nutritional composition, and at least one emulsifier selected from the group consisting
of: lecithin, monoglycerides, diglycerides, polyglycerol esters, milk phospholipids, citric acid
esters, datem and emulsifiers with a hydrophobic-lipophilic balance between 5 and 16. The
protein comprises non-micellar milk protein isolate or non-micellar milk protein concentrate and
a partially hydrolyzed caseinate. Additionally, the nutritional composition has a viscosity of
between 45 and 140 cps, a caloric density of 200 to 300 kcal per 100 mL of the nutritional
composition, and the total combined amount of fat and protein is 8-27 grams per 100 mL of the
nutritional composition.
[0006] In a second embodiment, a low viscosity, high caloric density liquid nutritional
composition is provided. The nutritional composition comprises protein in amount of between 8
to 27 grams per 100 mL of the nutritional composition; fat in an amount of between 0 and 17
grams per 100 mL of the nutritional composition; an anti-foaming agent; and a chelating agent
selected from the group consisting of divalent citrates, divalent phosphates, and combinations
thereof. The chelating agent is present in an amount of 0.3 weight % to 0.5 weight %. The
nutritional composition has a viscosity of between 45 and 140 cps. The protein comprises (i)
non-micellar milk protein isolate, non-micellar milk protein concentrate, or both and (ii) a
partially hydrolyzed caseinate. In addition, the total combined amount of fat and protein is 8-27
grams per 100 mL of the nutritional composition.
[0007] In a third embodiment, a method for the manufacture of a stable, low viscosity, high
caloric density liquid nutritional composition is provided. The steps of this method of
manufacture (as described herein) can also be useful for formulating liquid nutritional
compositions according to the first and second embodiments disclosed herein. The method
according to the third embodiment comprises the steps of combining fat and at least one
emulsifier selected from the group consisting of lecithin, monoglycerides, diglycerides,
polyglycerol esters, milk phospholipids, citric acid esters, datem and emulsifiers with a
hydrophobic-lipophilic balance between 5 and 16, to make a first mixture, and wherein the first
mixture is free of water. Then, a portion of the first mixture (i.e., 5 -20% by weight) is combined
with water in a ratio of 1:110 to 1:20 to make a second mixture. Non-micellar milk protein and
partially hydrolyzed caseinate are added to the second mixture to make a third mixture. The
non-micellar milk protein is selected from the group consisting of non-micellar milk protein
isolate, non-micellar milk protein concentrate, and combinations thereof. The third mixture is
combined with the remainder of the first mixture to make a fourth mixture. The fourth mixture is
then mixed with one or more of carbohydrates, vitamins and minerals to produce a liquid
nutritional composition having a viscosity of 45-140 cps, 8 to 27 grams of protein per 100 mL, 0-
17 grams of fat per 100 mL, and a total amount of protein and fat of 8-27 grams per 100 mL, as
well as other additional constituents of the liquid nutritional composition, including, but not
limited to flavorings, colorants, Ca-HMB, Lutein, EGCG, Plum Extract, Beta Alanine and
others.
DETAILED DESCRIPTION
[0008] Provided herein are liquid nutritional compositions that have a relatively low viscosity
while having a high caloric density. Also provided are methods for formulating the liquid
nutritional compositions. In certain embodiments, the liquid nutritional compositions comprise
non-micellar milk protein and lecithin. Additionally, the liquid nutritional compositions provide
at least 8g of protein per 100 mL of composition while achieving a low viscosity (i.e., 45-140
cps). In certain embodiments, the liquid nutritional compositions have a high caloric density (i.e.,
2-3 kilocalories per mL).
[0009] In a first embodiment, a low viscosity, high caloric density liquid nutritional composition
is provided. The nutritional composition comprises protein in amount of between 8 to 27 grams
per 100 mL of the nutritional composition, fat in an amount of between 0 and 17 grams per 100
mL of the nutritional composition, and at least one emulsifier selected from the group consisting
of lecithin, monoglycerides, diglycerides, polyglycerol esters, milk phospholipids, citric acid
esters, datem, emulsifiers with a hydrophobic-lipophilic balance between 5 and 16, and
combinations thereof. The protein comprises non-micellar milk protein isolate or non-micellar
milk protein concentrate and a partially hydrolyzed caseinate. Additionally, the nutritional
composition has a viscosity of between 45 and 140 cps, a caloric density of 200 to 300 kcal per
100 mL of the nutritional composition, and the total combined amount of fat and protein is 8-27
grams per 100 mL of the nutritional composition.
[00010] In a second embodiment, a low viscosity, high caloric density liquid nutritional
composition is provided. The liquid nutritional composition comprises protein in amount of
between 8 to 27 grams per 100 mL of the nutritional supplement; fat in an amount of between 0
and 17 grams per 100 mL of the liquid nutritional supplement; an anti-foaming agent; and a
chelating agent selected from the group consisting of divalent citrates, divalent phosphates, and
combinations thereof. The chelating agent is present in an amount of 0.3 weight % to 0.5 weight
%. The nutritional composition has a viscosity of between 45 and 140 cps. The protein comprises
(i) non-micellar milk protein isolate, non-micellar milk protein concentrate, or both, and (ii) a
partially hydrolyzed caseinate. In addition, the total combined amount of fat and protein is 8-27
grams per 100 mL of the liquid nutritional composition.
[0001 1] In a third embodiment, a method for the manufacture of a stable, low viscosity,
high caloric density liquid nutritional composition is provided. The steps of this method of
manufacture (as described herein) can also be useful for formulating liquid nutritional
compositions according to the first and second embodiments disclosed herein. The method
according to the third embodiment comprises the steps of combining fat and at least one
emulsifier selected from the group consisting of lecithin, monoglycerides, diglycerides,
polyglycerol esters, milk phospholipids, citric acid esters, datem, emulsifiers with a
hydrophobic-lipophilic balance between 5 and 16, and combinations thereof, to make a first
mixture, and wherein the first mixture is free of water. Then, a portion of the first mixture (i.e., 5
-20% by weight) is combined with water in a ratio of 1:20 to 1:1 10 to make a second mixture.
Non-micellar milk protein and partially hydrolyzed caseinate are added to the second mixture to
make a third mixture. The non-micellar milk protein is selected from the group consisting of
non-micellar milk protein isolate, non-micellar milk protein concentrate, and combinations
thereof. The third mixture is combined with the remainder of the first mixture to make a fourth
mixture. The fourth mixture is then mixed with one or more of carbohydrates, vitamins and
minerals to produce a liquid nutritional composition having a viscosity of 45-140 cps, 8 to 27
grams of protein per 100 mL, 0-17 grams of fat per 100 mL, and a total amount of protein and fat
of 8-27 grams per 100 mL, as well as other additional constituents of the liquid nutritional
composition, including, but not limited to flavorings, colorants, Ca-HMB, Lutein, EGCG, Plum
Extract, Beta Alanine and others.
[00012] Disclosed embodiments provide liquid nutritional compositions with high caloric
density and low viscosity. High caloric density as used herein refers to a calorie content that is at
a level of 200-300 kcal per 100 mL of the nutritional composition. Low viscosity as used herein
refers to a viscosity of 45-140 cps (at 22°C).
[00013] It should be understood that when discussing the liquid nutritional compositions
and compositions herein, that the discussion is equally applicable to nutritional compositions that
can be made according to the disclosed methods. In other words, in certain embodiments, the
disclosed methods can be viewed as methods for preparing a nutritional composition according
to the first embodiment disclosed herein or a nutritional composition according to the second
embodiment disclosed herein. However, it should also be understood that the disclosed methods
of the third embodiment can also be used to prepare nutritional compositions that vary in one or
more ways from the nutritional compositions of the first and second embodiments.
[00014] As used herein, the terms "stable," "shelf stable" and "stabilized," unless
otherwise specified, refers to a liquid nutritional composition that remains commercially stable
after being packaged and then stored at 18-24°C for at least 3 months, including from 9 months to
18 months, including from 9 months to 12 months and also including from 12 months to 18
months. Additionally, in certain embodiments, the term refers to a liquid nutritional composition
which has a single phase after shaking for a brief period (i.e., 5 to 10 se ). In certain
embodiments, the liquid nutritional compositions disclosed herein (according to the first and
second embodiments) have a relatively high protein concentration (i.e. 8-27 grams per 100 mL of
nutritional composition), while retaining a shelf stability generally only achieved by nutritional
compositions having lower protein concentrations.
[00015] In certain embodiments according to the first, second and third embodiments
disclosed herein, the liquid nutritional compositions are administered (or consumed) orally as
needed to provide the desired level of nutrition. In certain of these embodiments, the nutritional
compositions are administered (or consumed) in the form of one to two servings daily or in one
or two or more divided doses daily (e.g. , when in liquid form serving sizes typically range from
about 100 to about 300 mL, including from about 125 to about 250 mL, including from about
190 mL to about 240 mL and also including 8 fluid ounces and 10 fluid ounces). Various calorie
contents may be associated with each serving of the nutritional compositions according to the
first, second and third embodiments disclosed herein, typically from 200 to 750 Kcal, including
200 to 400 Kcal; 250 to 350 Kcal; or 200 to 300 Kcal. In certain embodiments, according to the
first, second and third embodiments, the serving size of the nutritional compositions are in the
range of 3-5 ounces, including 4 ounces and provide from 240 to 350 calories. Generally as used
herein, a serving may be construed as any amount which is intended to be consumed in one
sitting or within one hour or less.
[00016] As previously mentioned, the liquid nutritional compositions according to the
first, second and third embodiments provided herein have a relatively low viscosity, i.e., between
45 and 140 cps. In certain other embodiments according to the first, second and third
embodiments, the liquid nutritional compositions have a viscosity of between 45 and 125 cps,
including a viscosity of between 45 and 90 cps, and including a viscosity of between 45 and 75
cps including a viscosity of between 50 and 70 cps or in other embodiments a viscosity of
between 50 and 65 cps. In certain embodiments, according to the first, second and third
embodiments, the liquid nutritional compositions have a viscosity of between 90 and 125 cps.
[00017] As previously discussed, the liquid nutritional compositions according to the first,
second and third embodiment include between 8 and 27 grams of protein per 100 mL of the
liquid nutritional compositions, including between 8 and 12 grams of protein per 100 mL of the
liquid nutritional compositions with the protein comprising non-micellar milk protein isolate,
non-micellar milk protein concentrate or combinations thereof, and (ii) partially hydrolyzed
caseinate. The term non-micellar milk protein refers to milk protein which is no longer native
protein; the term likewise refers to milk protein which has been denatured. While in its nondenatured
state, proteins in milk naturally form micelles in an aqueous environment. Denaturing
results in a breakdown of a portion of these naturally occurring protein micelles present in milk.
The denaturing of the milk proteins can be achieved according to one or more treatments such as
hydrolysis, heat treatment, reaction with soluble divalent minerals, and combinations thereof. In
other embodiments, the denaturing of the milk proteins is achieved through homogenization by
pressurization at 4000 psig.
[00018] The term milk protein concentrate is generally used to refer to a milk protein
containing product that has had a considerable amount of the inherent water from ordinary milk
removed and also has had inherent fat from the ordinary milk removed. The term milk protein
isolate is generally used to refer to a type of milk-protein containing product that has not only
had a considerable amount of the inherent water from ordinary milk removed and inherent fat but
also a certain amount of inherent lactose removed. In most instances, milk protein isolates can
be considered to be a type of further purified milk protein concentrate.
[00019] As used herein, the phrase milk protein isolate should be understood to mean a
source of milk protein that comprises milk that has been concentrated (i.e., to remove water and
fat) and has also had a portion of its lactose content removed. Generally, commercially available
milk protein isolates contain about 85-90 weight % protein (or more), about 2-5 weight %
lactose, minimal fat (i.e., 1-3%) and about 5-6 weight % water. As used herein, the phrase milk
protein concentrate should be understood to mean a source of milk protein that comprises milk
that has had a considerable amount of water and a portion of the inherent fat removed.
Generally, commercially available milk protein isolates contain about 40- less than 85 weight %
protein (sometimes less), minimal fat and about a somewhat higher amount of lactose than milk
protein isolates. Certain manufacturers may use the term milk protein concentrate to refer to
milk-based protein products even if they contain at least 85 weight % protein and such products
should be considered to be within the scope of the term milk protein isolate as that term is used
herein.
[00020] When non-micellar milk protein concentrate is utilized in the liquid nutritional
compositions according to the first, second and third embodiments disclosed herein, the nonmicellar
milk protein concentrate may be provided by one or more sources. In certain
embodiments according to the first, second and third embodiments disclosed herein, nonmicellar
milk protein concentrate comprises 0-90 weight % (i.e., 0 to 90 weight %), including up
to 80 weight % (i.e., 0 to 80 weight %) including up to 75 weight % (i.e., 0 to 75 weight %),
including up to 50 weight % (i.e., 0 to 50 weight %) of the total protein. Various commercial
sources of non-micellar milk protein concentrate suitable for use in the liquid nutritional
compositions according to the first, second and third embodiments are available from, Aria
Foods Inc., USA 645 Martinsville Road, 3rd floor Basking Ridge, NJ 07920; FrieslandCampina
DMV 1285 Rudy Street Onalaska, Wisconsin, 54650; Kerry Ingredients & Flavours 3330
Millington Road Beloit, WI 5351 1; and Fonterra USA Inc. Columbia Centre III, Ste. 700, 9525
W. Bryn Mawr Ave. Rosemont, IL 60018.
[00021] When non-micellar milk protein isolate is utilized in the liquid nutritional
compositions according to the first, second and third embodiments disclosed herein, the nonmicellar
milk protein isolate may be provided by one or more sources. In certain embodiments
according to the first, second and third embodiments disclosed herein, non-micellar milk protein
isolate comprises 0-90 weight % (i.e., 0 to 90 weight %), including up to 80 weight % (i.e., 0 to
80 weight %) including up to 75 weight % (i.e., 0 to 75 weight %), including up to 50 weight %
(i.e., 0 to 50 weight %) of the total protein. Various commercial sources of non-micellar milk
protein isolate suitable for use in the liquid nutritional compositions according to the first, second
and third embodiments are available from, Aria Foods Inc., USA 645 Martinsville Road, 3rd
floor Basking Ridge, NJ 07920; FrieslandCampina DMV 1285 Rudy Street Onalaska,
Wisconsin, 54650; Kerry Ingredients & Flavours 3330 Millington Road Beloit, WI 5351 1; and
Fonterra USA Inc. Columbia Centre III, Ste. 700, 9525 W. Bryn Mawr Ave. Rosemont, IL
60018.
[00022] In certain embodiments according to the first, second and third embodiments
disclosed herein, the non-micellar milk protein component comprises a combination of non
micellar milk protein concentrate and non-micellar milk protein isolate. Various relative
amounts of each may be utilized ranging from 0-100% of each, including amounts such as 50/50
isolate/concentrate, 25/75 isolate/concentrate, 75/25 isolate/concentrate, 40/60
isolate/concentrate and 60/40 isolate/concentrate, all based upon the total amount of non-micellar
milk protein. Additionally, in certain other embodiments, according to the first, second and third
embodiments the protein comprises some amount of micellar milk protein. The micellar milk
protein is present in an amount in accordance with the amounts of nonmicellar milk protein and
hydrolyzed casein. Further, when present in the disclosed embodiments, micellar milk protein is
a minor component (i.e., less than 25% by weight of protein).
[00023] As previously discussed, according to the first, second and third embodiments, the
protein of the liquid nutritional compositions includes a partially hydrolyzed caseinate. As used
herein, the term "partially hydrolyzed caseinate" refers to a caseinate in which a portion of the
protein has been hydrolyzed. (e.g., 0.5 to 10% hydrolyzed, 0.5 to 20%, 0.5 to 30%, 0.5 to 40%,
0.5 to 50%, 0.5 to 60%, 0.5 to 70%, 0.5 to 80%, and 0.5 to 90% hydrolyzed). Another way of
referring to the extent of hydrolyzation in a partially hydrolyzed caseinate is by Degree of
Hydrolzyzation (DH). A DH value of, for example, 30 refers to casein in which 30% of the total
casein is hydrolyzed casein. When used in the disclosed liquid nutritional compositions, the
partially hydrolyzed caseinate comprises 10-60 weight % (i.e., 10 to 60 weight %), including 10
to 50 weight %; including 10 to 40 weight %>, including 10 to 30 weight %>, including 20 to 25
weight % of the total protein. When present in the disclosed embodiments, the partially
hydrolyzed caseinate may include sodium caseinate, potassium caseinate, magnesium caseinate,
calcium caseinate and combinations thereof. Further, the partially hydrolyzed casemates useful
in the disclosed embodiments may be achieved through reaction of the caseinate with soluble
divalent minerals. Examples of soluble divalent minerals useful according to the disclosed
embodiments include Ca2 , and Mg2 among others. In addition to the protein sources discussed
above {i.e., non-micellar milk protein concentrate, non-micellar milk protein isolate, and
hydrolyzed casein).
[00024] In certain embodiments, the liquid nutritional compositions according to the first,
second and third embodiments disclosed herein may also contain protein from one or more other
sources, in an amount or amounts that is in accordance with the guidance on the amounts of nonmicellar
milk protein concentrate, non-micellar milk protein isolate and partially hydrolyzed
caseinate, discussed above. Generally according to the first and second embodiments, the other
protein source(s) (when present) will not comprise (in total) more than 25 weight % of the total
protein, no more than 20 weight %, no more than 15 weight % or no more than 10 weight %.
Suitable and non-limiting examples of additional protein sources include whey from milk,
animal products {e.g., meat, fish, egg albumen), cereals {e.g., rice, corn), vegetable {e.g., soy,
pea, potato, canola), algal protein, mycoprotein, or combinations thereof. The additional protein
sources can also include free amino acids known for use in nutritional compositions, nonlimiting
examples of which include L-tryptophan, L-glutamine, L-tyrosine, L-methionine, Lcystine,
taurine, L-arginine, carnitine, and combinations thereof.
[00025] When pea protein is present in nutritional compositions according to the disclosed
embodiments, it may be provided as an intact pea protein. Particularly suitable intact pea protein
for use in the nutritional compositions of the present disclosure includes intact pea proteins
derived from pisum sativum. One suitable commercially available intact pea protein for use in
the nutritional compositions of the present disclosure is NUTRALYS® F85F pea protein isolate
(about 83% by weight intact pea protein) (Roquette Freres, Lestrem France).
[00026] When soy protein is utilized in the liquid nutritional compositions disclosed
herein, the soy protein may be provided by one or more than one source. Common forms of soy
protein include soy protein concentrates and soy protein isolates. When soy protein is utilized in
the liquid nutritional compositions disclosed herein, the amount of soy protein that may be
utilized in the liquid nutritional compositions is generally up to 25 weight % (i.e., 0 to 25 weight
%) of the total protein, in certain embodiments 1-25 weight % of the total protein, 1-15 weight %
of the total protein in other embodiments and can be 1-10 weight % of the total protein in yet
other embodiments. Preferably, the soy protein is soy protein isolate. Commercial sources of soy
protein are well known in the nutrition art, some non-limiting examples of which include soy
protein isolates distributed by The Solae Company under the trade designation "Soy Protein
Isolate EXP-H01 18," Έ CR-E-0101, and "Supro Plus 675 and ADM ProFam."
[00027] When whey protein is utilized in the liquid nutritional compositions disclosed
herein, the whey may be provided by one or more than one source. Common forms of whey
protein include whey protein concentrate, whey protein isolate and partially hydrolyzed whey
protein. Preferably, the whey protein is present as a whey protein isolate. Various commercial
sources of whey protein exist, containing varying concentrations of protein such as about 75
weight % protein (w/w, based on the total weight of the protein source). As previously discussed,
when whey protein is utilized in the liquid nutritional compositions disclosed herein, the amount
of whey protein utilized in the liquid nutritional compositions is generally up to 25 weight %
(i.e., 0 to 25 weight %) of the total protein, in certain embodiments 1-25 weight % of the total
protein, 1-15 weight % of the total protein in other embodiments and can be 1-10 weight % of
the total protein in yet other embodiments. In certain embodiments, both whey protein and soy
protein are used in the liquid nutritional compositions, in these instances, the total combined
amount of soy and whey protein used comprises 1-25 weight %.
[00028] When carbohydrates are present in embodiments according to the first, second and
third embodiments, the carbohydrates may be provided by a single source or by more than one
source. The particular amount of carbohydrate present in the liquid nutritional compositions may
vary depending upon the desired amount of calories in the nutritional compositions.
Carbohydrate concentrations usually fall within the range of 20 weight % to 50 weight %
(percentages are weight percentages based upon the total weight of the liquid nutritional
compositions) including 20 to 40 weight % and 20 to 30 weight %. The amount of carbohydrates
present in the liquid nutritional compositions according to the first, second and third
embodiments disclosed herein can also be characterized as a percentage of total calories in the
nutritional composition and may vary widely from 5-90%. In certain embodiments according to
the first, second and third embodiments disclosed herein, the carbohydrates comprise 10-80%,
20-70%, 30-60%, or 40-55% of the total calories of the liquid nutritional composition.
[00029] Various commercial sources of carbohydrates exist and may be utilized in liquid
nutritional compositions according to the first, second and third embodiments disclosed herein.
Non-limiting examples of suitable carbohydrates or sources thereof for use in the liquid
nutritional compositions disclosed herein include maltodextrin, native, hydrolyzed or modified
starch or cornstarch, isomaltulose, glucose polymers, corn syrup, corn syrup solids, rice-derived
carbohydrates, glucose, fructose, lactose, sucrose, high fructose corn syrup, honey, sugar
alcohols (e.g., maltitol, erythritol, sorbitol), slow digesting starches, barley beta glucan, glycerin,
sucromalt, inulin and combinations thereof.
[00030] In certain embodiments according to the first, second and third embodiments the
liquid nutritional compositions include fat or at least one source of fat. As previously discussed,
the maximum amount of fat according to certain embodiments of the first and second
embodiments is between 0 and 17 grams per 100 mL, including between 0 and 12.5 grams per
100 mL of the liquid nutritional composition. As discussed previously, the amount of fat
according to certain embodiments of the first, second and third embodiment is from 0 to 50% of
the total calories in the nutritional composition, including 0 to 10%, 0 to 20% and 0 to 40% of
the total calories in the nutritional composition. Within these ranges, the particular amount of fat
that is present in a nutritional composition according to the first, second and third embodiments
disclosed herein may vary depending upon the nutritional needs of the intended user.
[00031] Various commercial sources of fat exist and may be utilized in certain
embodiments according to the first, second and third embodiments. Non-limiting examples of
suitable fats or sources thereof for use in the nutritional compositions disclosed herein include
coconut oil, fractionated coconut oil, soy oil, corn oil, olive oil, safflower oil, high oleic
safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil,
palm and palm kernel oils, palm olein, canola oil, fish oil, cottonseed oils, lecithin, datem, mono
and di glycerides, milk phospholipids, polyglycerol esters, citric acid esters and combinations
thereof.
[00032] As previously mentioned, according to the first and second and in certain
embodiments of the third embodiment, in the liquid nutritional compositions the sum of the total
amount of protein added to the total amount of fat equals 8-27 grams per 100 mL. For example,
if the amount of protein in the nutritional composition is 16 grams per 100 mL, then the
corresponding amount of fat must be no more than 11 grams per 100 mL (i.e., 0-1 1 g/lOOmL).
[00033] Lecithin is the popular and commercial name for a naturally occurring mixture of
phosphatides (also called phospholipids or phosphoglycerides), which varies in color from light
tan to dark reddish brown and in consistency from a fluid to a plastic solid. Lecithin is the
gummy material contained in crude vegetable oils and is generally removed from the oils by
degumming. Soybeans are currently the most important source of commercial lecithin and
lecithin is the most important by-product of the soy oil processing industry because of its many
applications in foods and industrial products, but it should be understood that the present
disclosure encompasses the use of lecithins other than soy-sourced lecithin. The three main
phosphatides in the complex mixture called sold commercially as soy lecithin are phosphatidyl
choline, phosphatidyl ethanolamine (popularly called "cephalin"), and phosphatidyl inositols
(also called inositol phosphatides). Commercial sources of soy lecithin also typically contain
roughly 30-35% unrefined soy oil.
[00034] Soy lecithin can be classified into three broad types: unrefined or natural, refined,
and chemically modified. Unrefined or natural lecithin comes in six basic varieties, long defined
by specifications of the National Soybean Processors Association: plastic or fluid, each either
unbleached, bleached, or double bleached. (Because f uid lecithins are easier to handle and
dissolve more rapidly in various solvents, only small amounts of plastic grades are now
produced.) Refined lecithin (which has had the oil removed using acetone) comes in three basic
varieties: custom blended natural, oil free phosphatides (as is or custom blended), and alcoholfractionated
oil-free phosphatides (as is or custom blended). These latter special refined grades,
which may contain 60-99.7% phosphatidyl choline, are used mostly for pharmaceutical
applications and research. Chemically modified lecithin products, altered through selective
chemical treatment, improve lecithin's compatibility to certain systems.
[00035] As previously discussed, in certain embodiments according to the first and third
embodiments, the liquid nutritional compositions include lecithin. When present, the lecithin
may be provided by a single source or by more than one source. In certain embodiments
according to the first and third embodiments, lecithin is present in an amount based on the
amount of fat per 100 mL of nutritional composition, accordingly, lecithin is present in an
amount of between 0.5 and 5% of the fat present in the liquid nutritional composition, including
from 0.5 to 2 % based on weight of fat in the nutritional composition. In certain embodiments the
amount of lecithin utilized within the liquid nutritional composition can also be based upon the
relative amount of fat contained within the liquid nutritional composition, according to the
foregoing amounts. Commercial sources of lecithin are available including soy lecithin and
sunflower lecithin among others, non- limiting examples include: Natural unbleached lecithin
supplied by Solae and acetylated lecithin from ADM Corporation.
[00036] In certain other embodiments according to the first and third embodiments, lecithin
may be replaced with another emulsifying agent. Emulsifying agents useful in the disclosed
embodiments include mono and diglycerides, polyglycerol esters, milk phospholipids, citric acid
esters, and datem. Moreover, other emulsifiers useful with the disclosed embodiments will be
those emulsifiers with a hydrophilic lipophilic balance (HLB) of between 5 and 16, including but
not limited to certain lecithins.
[00037] As previously discussed, according to the second embodiment, the liquid
nutritional compositions comprise an anti-foaming agent. In certain embodiments according to
the first and third embodiments disclosed herein, the liquid nutritional compositions optionally
contain an anti-foaming agent. Non-limiting examples of anti-foaming agents useful for the
liquid nutritional compositions disclosed herein include: simethicone, lecithin, milk
phospholipid, dimethylpolysiloxane and fumed silicone dioxide. The anti-foaming agent may be
present in an amount of between 0.6 and 6% by weight of the nutritional composition.
[00038] In certain embodiments according to the second embodiment, the nutritional
composition further comprises a chelating agent. Examples of chelating agents useful with the
nutritional compositions disclosed herein include monovalent chelating agents and divalent
chelating agents. Non-limiting examples of monovalent chelating agents useful with the
nutritional compositions disclosed herein include: sodium citrate, potassium citrate, potassium
phosphate, sodium phosphate and combinations thereof. In other embodiments disclosed herein,
the chelating agents include divalent chelating agents such as divalent citrates and divalent
phosphates. More particularly, the divalent citrate may be calcium citrate, magnesium citrate, tri
magnesium dicitrate or combinations thereof; and the divalent phosphate may be magnesium
phosphate, calcium phosphate, mono-calcium phosphate, di-calcium phosphate, disodium
hydrogen phosphate, dipotassium hydrogen phosphate and combinations thereof. When present
in the nutritional compositions, the chelating agents are generally present in an amount of 0.3
weight % - 0.5 weight % based on the total weight of the nutritional composition.
[00039] The liquid nutritional compositions according to the first, second and third
embodiments disclosed herein can have widely varying calorie contents. One way to express the
calorie content of a liquid nutritional composition is on a kilocalorie per serving basis.
Generally, the liquid nutritional compositions according to the first, second and third
embodiments disclosed herein have an amount of calories of 200-1000 kilocalories per 3 to 5
ounce serving. In certain embodiments according to the first, second and third embodiments
disclosed herein, the liquid nutritional compositions have a calorie content of 200-750 kilocalorie
(kcal) per serving, including 200-450 kcal per serving, including 240-350 kcal per serving.
[00040] In certain embodiments according to the first, second and third embodiments
disclosed herein, the liquid nutritional compositions contain other ingredients, non-limiting
examples of which include preservatives, antioxidants, emulsifying agents, buffers,
pharmaceutical actives, additional nutrients, colorants, flavors, thickening agents and stabilizers.
In certain embodiments, stabilizers present in the disclose embodiments include: octenyl succinic
anhydride, gellan gum, alginate, pectin, guar gum, locust bean gum, konjack, carboxymethyl
cellulose and microcrystalline cellulose and combinations thereof. Those of skill in the art will
recognize that many different gum forms, in addition to those listed above, may be used in the
liquid nutritional compositions disclosed herein and still fall within the disclosed embodiments.
[00041] In certain embodiments according to the first, second and third embodiments
disclosed herein, the liquid nutritional compositions contain vitamins or related nutrients, nonlimiting
examples of which include vitamin A, vitamin E, vitamin K, thiamine, riboflavin,
pyridoxine, vitamin B12, carotenoids (e.g., lutein), niacin, folic acid, pantothenic acid, biotin,
vitamin C, choline, inositol, salts, and derivatives thereof, and combinations thereof.
[00042] In certain embodiments according to the first, second and third embodiments
disclosed herein, the liquid nutritional compositions contain b-hydroxy- b-methylbutyrate
(HMB). HMB is a metabolite of the essential amino acid leucine, and has the IUPAC name 3-
hydroxy-3-methylbutanoic acid. One useful form of HMB is the calcium salt of HMB, also
designated as Ca-HMB, which is most typically the monohydrate calcium salt. The HMB used
in the nutritional compositions described herein can come from any source. Calcium HMB
monohydrate is commercially available from Technical Sourcing International (TSI) of Salt Lake
City, Utah. Note that all of the amounts of HMB described herein are based on use of Ca-HMB
monohydrate.
[00043] Although calcium monohydrate is the preferred form of HMB for use herein, other
suitable sources include HMB as a free acid, a salt, an anhydrous salt, an ester, a lactone, or other
product forms that provide a bioavailable form of HMB suitable for administration. Nonlimiting
examples of suitable salts of HMB for use herein include HMB salts, hydrated or
anhydrous, of sodium, potassium, chromium, calcium, or other non-toxic salt forms.
[00044] In certain embodiments according to the first, second and third embodiments
disclosed herein, the liquid nutritional compositions contain minerals, non-limiting examples of
which include calcium, phosphorus, magnesium, iron, zinc, manganese, copper, sodium,
potassium, molybdenum, chromium, selenium, chloride, and combinations thereof.
[00045] In certain embodiments according to the first, second and third embodiments
disclosed herein, the liquid nutritional compositions also optionally include one or more masking
agents to reduce or otherwise obscure the development of any residual bitter flavors and after
taste in the emulsions over time. Suitable masking agents include natural and artificial
sweeteners, sodium sources such as sodium chloride, and hydrocolloids, such as guar gum,
xanthan gum, carrageenan, and combinations thereof. The amount of masking agent in the
nutritional emulsion may vary depending upon the particular masking agent selected, other
ingredients in the formulation, and other formulation or product target variables. Such amounts,
however, most typically range from 0.1% to 3 %, including from 0.15% to 3 %, and also
including from 0.18% to 2.5%, by weight of the nutritional emulsion.
[00046] As previously mentioned, methods for the production of a stable, low viscosity,
high caloric density liquid nutritional composition are provided. The steps of this method of
manufacture (as described herein) can also be useful for formulating liquid nutritional
compositions according to the first and second embodiments disclosed herein. The method of
the third embodiment comprises the formulation of a series of mixtures which are then combined
in certain amounts in order to achieve the low viscosity, high caloric density liquid nutritional
compositions described herein. The method comprises combining fat and at least one emulsifier
selected from the group consisting of lecithin, monoglycerides, diglycerides, polyglycerol esters,
milk phospholipids, citric acid esters, datem and emulsifiers with a hydrophobic-lipophilic
balance between 5 and 16, to make a first mixture, where the lecithin is present in an amount of
0.5 to 4 weight %, based on the total amount of fat, and the first mixture is free of water. A
portion (i.e., 5 to 20% by weight of the first mixture) of this first mixture is then combined with
water in a ratio of 1:20 to 1:1 10 to make a second mixture; including 5-10% by weight of the
first mixture which is combined with water in ratio of 1:1 10 to 1:55. Once the second mixture is
formed, the desired amounts of non-micellar milk protein and partially hydrolyzed caseinate are
combined with the second mixture to make a third mixture. The non-micellar milk protein is
selected from the group consisting of non-micellar milk protein isolate, non-micellar milk
protein concentrate, and combinations thereof and is selected commensurate with the discussion
provided above. Likewise, the partially hydrolyzed caseinate is selected according to the relevant
discussion provided above. The third mixture is then combined with the remainder of the first
mixture to make a fourth mixture. The fourth mixture is then mixed with any additional
ingredient to produce a liquid nutritional composition having a viscosity of 45-140 cps (and in
certain embodiments, a viscosity of 90-125 cps), 8 to 27 grams of protein per 100 mL, 0 to 17
grams of fat per 100 mL and a total amount of protein and fat of 8-27 grams per 100 mL.
[00047] The viscosity values provided herein are measured at 22.5 °C ± 0.5°C, using a
Brookfield Model LV Series (Model DV-II) Viscometer, with a # 1 spindle installed, operated at
60 rpm (to create a shear rate of about 13 sec-1, utilizing AR&S Method 11.01. The Brookfield
Viscometer is a rotational viscometer. It measures the torque required to rotate an immersed
spindle (geometry) in a fluid. The spindle is driven by a motor through a calibrated spring;
deflection of the spring is indicated by a pointer and dial or a digital display. The viscous drag of
the fluid against the spindle is measured by the spring deflection. The measurement range is
determined by the rotational speed of the spindle, the size and shape of the spindle, the container
the spindle is rotating within and the full scale torque of the calibrated spring. As those skilled in
the art will appreciate, while viscosities can be measured under other conditions and according to
different methods, modification of one or more test conditions may result in a different viscosity
number.
Examples
[00048] The following examples illustrate specific and exemplary embodiments and
features of the liquid nutritional compositions disclosed herein. The examples are provided
solely for the purposes of illustration and should not be construed as limitations of the present
disclosure. Numerous variations over these specific examples are possible without departing
from the spirit and scope of the presently disclosed liquid nutritional compositions.
[00049] Example 1 : The table below shows compositional data for a series of liquid
nutritional compositions formulated according to embodiments of liquid nutritional compositions
described herein. Further, the table shows measured viscosity data for the compositions. The
viscosity was measured at room temperature (i.e. approximately 22.5 °C) with a Brookfield LV
series viscometer with agitation for 10 sec. prior to measurement at 60 rpm.
Table 1
Batch Code 1401 1402 1403 1404 1405 1406
Batch Size TY, lbs 200 100 100 100 100 100
Finished Product TS 44.20% 44.20% 44.20% 44.20% 44.20% 44.20%
Protein 1 8.90% 8.90% 8.90% 8.90% 8.90% 8.90%
Fat 8.16% 8.16% 8.16% 8.16% 8.16% 8.16%
Product density, g/ml 1.14 1.14 1.14 1.14 1.14 1.14
Calories, per ml 2.4 2.4 2.4 2.4 2.4 2.4
Non-Acid Casein Proteins2
Sodium Caseinate 25% 25% 25% 25% 25% 25%
Hydro lyzed/ Alanate 167
Milk Protein Concentrate 75% 75% 75% 75% 75% 75%
4861 (Fonterra)
CHECK PROTEFN TOTAL 100% 100% 100% 100% 100% 100%
Fat & Emulsifiers Sources
weight %of ingredient
HO Safflower Oil (HOSO) 39% 39% 39% 39% 39% 39%
Canola oil 39% 39% 39% 39% 39% 39%
Corn Oil 20% 20% 20% 20% 20% 20%
Soy Lecithin 2% 2% 2% 2% 2% 2%
CHECK FAT TOTAL 100% 100% 100% 100% 100% 100%
Measured Viscosity 57.8 53.6 52.3 50.6 51.8 51.9
1 The percentages of protein represent the weight % of actual protein in the nutritional
composition (i.e., grams protein per grams of nutritional composition) and not the weight % of
the protein source.
2 The percentages of sodium caseinate and milk protein concentrate that are provided represent
the relative percentages of protein provided by the source materials and not the relative weight
percentages of the source materials.
[00050] In the exemplary formulations provided in Table 1, the amount of soy lecithin
utilized is 2% by weight, based upon the total amount of fat utilized in the liquid nutritional
composition. The particular type of soy lecithin used in formulating these compositions was
acetylated lecithin (which is lecithin in soy oil). It is to be understood that when using a more
refined or processed lecithin such as acetylated lecithin that the amounts may vary allowing for
the use of less soy lecithin, while still achieving a low viscosity liquid nutritional composition
and falling under the general concepts disclosed herein. The milk protein concentrate utilized in
the compositions was Fonterra MPC 485 1.
[00051] Example 2 : Table 2 below shows a bill of materials for a liquid nutritional
composition according to the disclosed embodiments. The measured viscosity of the formulation
presented in Table 2 is 70 cP.
High oleic sunflower oil 48.8 kg
Oligofructose (fructo-oligosaccharides) 24.8 kg
Soy oil 21.7 kg
Sucrose 21.2 kg
Sodium caseinate 16.6 kg
Canola oil 8.1 kg
Magnesium chloride 1.9 kg
Lecithin, PCR negative, IP 1.9 kg
Sodium citrate 1.8 kg
Potassium citrate 1.8 kg
Potassium phosphate dibasic 1.2 kg
Magnesium sulfate 785.0 g
Choline chloride 660.0 g
UTM/TM premix 22277 530.3 g
Ferrous sulfate 55.8g
Zinc sulfate 36.9 g
Citric acid 32.7 g
Manganese sulfate 13.5 g
Cupric sulfate 6.3 g
Sodium molybdate 296.3 mg
Chromium chloride 243.8 mg
Sodium selenate 194.9 mg
Diluent maltodextrin q.s.
Artificial cream flavor 500.0 g
Calcium carbonate 496.6 g
Ascorbic acid 370.0 g
Vitamin premix 290.1 g
Niacinamide 19.8 g
Calcium pantothenate 16.3 g
Pyridoxine hydrochloride 5.1 g
Thiamine hydrochloride 4.2 g
Riboflavin 4.2 g
Folic acid 521.4 mg
Biotin 81.2 mg
Cyanocobalamin 5.1 mg
Diluent dextrose anhydrous q.s.
Artificial vanilla flavor 200.0 g
Taurine 153.1 g
L-carnitine 153.1 g
*Potassium hydroxide 142.8 g
Potassium chloride 110.5 g
Vitamin A palmitate 7.5 g
Vitamin A palmitate 4.1 g
Diluent (corn or sunflower oil) q.s.
Vitamin D3 oil soluble 850.4 mg
Vitamin D3 21.3 mg
Diluent (MCT oil) q.s.
Potassium iodide 195.1 mg
Phylloquinone 50.0 mg
dl-alpha tocopheryl acetate As needed
Maltodextrin DE18 As needed
*Citric acid As needed
*Potassium hydroxide 40% As needed
Ingredient water q.s.
[00052] Example 3 : Table 3 below shows the per serving values for calories, caloric
density, protein, total carbohydrates, sugars, and total fat for the formulation detailed in Table 2.
The table includes data for both 100 mL serving size and 125 mL serving size.
[00053] Example 4 : Table 4 below shows a comparison of two exemplary liquid
nutritional compositions according to the disclosed embodiments. The liquid nutritional
composition on the left has a volume of 100 mL and the composition on the right has a volume
of 125 mL.
Table 4
100 mL serving* 125 mL serving*
Calories 240.00 300.00
Caloric density 2.40 2.40
Protein, g 10.00 12.50
Total Carbs, g 32.30 40.38
Sugars, g 10.87 11.43
Fiber, g
Total Fat, g 7.87 9.84
Sodium, mg 162.00 202.50
Potassium, mg 233.60 292.00
Chloride, mg 89.60 112.00
Calcium, mg 191.90 239.88
Phosphorus, mg 172.80 216.00
Magnesium, mg 47.97 59.96
Iodine, meg 35.18 43.98
Manganese, mg 0.80 1.00
Copper, mg 0.29 0.36
Zinc, mg 2.88 3.60
Iron, mg 3.36 4.20
Selenium, meg 13.27 16.59
Chromium, meg 11.99 14.99
Molybdenum, meg 25.59 31.99
Vitamin A, meg RE 140.72 175.90
Beta-carotene, meg RE
Vitamin D , meg 3.20 4.00
Vitamin E, mg 3.36 4.20
Vitamin K, meg 19.19 23.99
Thiamin, mg 0.32 0.40
Riboflavin, mg 0.43 0.54
Niacin, mg 4.16 5.20
Pantothenic Acid, mg 1.76 2.20
Vitamin B6, mg 0.43 0.54
Folic Acid, meg 63.97 79.96
Vitamin B12, meg 0.88 1.10
Biotin, meg 9.59 11.99
Vitamin C, mg 19.19 23.99
Choline, mg 87.95 109.94
L-Carnitine,mg
Taurine, mg
Viscosity, cps 70 cP
[00054] While the discussion above refers to the nutritional compositions in liquid form,
one of skill in the art will recognize that the nutritional compositions may be prepared as
reconstitutable powder and still fall within the disclosed embodiments according to the first,
second and third embodiments. A nutritional solid, such as a spray dried nutritional powder or
drymixed nutritional powder, may be prepared by any collection of known or otherwise effective
technique, suitable for making and formulating a nutritional powder.
[00055] For example, when the nutritional powder is a spray dried nutritional powder, the
spray drying step may likewise include any spray drying technique that is known for or otherwise
suitable for use in the production of nutritional powders. Many different spray drying methods
and techniques are known for use in the nutrition field, all of which are suitable for use in the
manufacture of the spray dried nutritional powders herein.
[00056] One method of preparing the spray dried nutritional powder comprises forming
and homogenizing an aqueous slurry or liquid comprising predigested fat, and optionally protein,
carbohydrate, and other sources of fat, and then spray drying the slurry or liquid to produce a
spray dried nutritional powder. The method may further comprise the step of spray drying,
drymixing, or otherwise adding additional nutritional ingredients, including any one or more of
the ingredients described herein, to the spray dried nutritional powder.
[00057] In certain embodiments according to the first, second and third embodiments
disclosed herein, the liquid nutritional compositions, may potentially provide either a primary
source or a supplemental source of nutrition to an individual. In this context, a sole source of
nutrition is one that can be administered once or multiple times each day to potentially provide
an individual with all or substantially all their fat, protein, carbohydrate, mineral, and vitamin
needs per day or during the intended period of administration. A supplemental source of
nutrition is defined herein as a dietary source that does not provide an individual with a
potentially sole source of nutrition.
[00058] To the extent that the term "includes" or "including" is used in the specification or
the claims, it is intended to be inclusive in a manner similar to the term "comprising" as that term
is interpreted when employed as a transitional word in a claim. Furthermore, to the extent that
the term "or" is employed (e.g., A or B) it is intended to mean "A or B or both." When the
applicants intend to indicate "only A or B but not both" then the term "only A or B but not both"
will be employed. Thus, use of the term "or" herein is the inclusive, and not the exclusive use.
See Bryan A. Garner, A Dictionary of Modern Legal Usage 624 (2d. Ed. 1995). Also, to the
extent that the terms "in" or "into" are used in the specification or the claims, it is intended to
additionally mean "on" or "onto." Furthermore, to the extent the term "connect" is used in the
specification or claims, it is intended to mean not only "directly connected to," but also
"indirectly connected to" such as connected through another component or components.
[00059] While the present application has been illustrated by the description of
embodiments thereof, and while the embodiments have been described in considerable detail, it
is not the intention of the applicants to restrict or in any way limit the scope of the appended
claims to such detail. Additional advantages and modifications will readily appear to those
skilled in the art. Therefore, the application, in its broader aspects, is not limited to the specific
details, the representative apparatus, and illustrative examples shown and described.
Accordingly, departures may be made from such details without departing from the spirit or
scope of the applicant's general inventive concept.
What is claimed is:
Claim 1. A low viscosity, high caloric density liquid nutritional composition comprising:
a) protein in an amount of between 8 to 27 grams per 100 mL of the nutritional
composition, the protein comprising (i) non-micellar milk protein isolate, non-micellar milk
protein concentrate, or both, and (ii) a partially hydrolyzed caseinate;
b) fat in an amount of between 0 and 17 grams per 100 mL of the nutritional
composition; and
c) at least one emulsifier selected from the group consisting of lecithin, monoglycerides,
diglycerides, polyglycerol esters, milk phospholipids, citric acid esters, datem and emulsifiers
with a hydrophobic-lipophilic balance between 5 and 16, and combinations thereof;
wherein the nutritional composition has a viscosity of between 45 and 140 cps, a caloric density
of 200 to 300 kcal per 100 mL of the nutritional composition, and wherein the total combined
amount of fat and protein is 8-27 grams per 100 mL of the nutritional composition.
Claim 2. The low viscosity, high caloric density liquid nutritional composition of claim 1,
wherein the composition has a caloric density of 200 to 240 kcal per 100 mL of the nutritional
composition.
Claim 3. A low viscosity, high caloric density liquid nutritional composition according to
claim 1, wherein the protein comprises 0-25% by weight of protein from a partially hydrolyzed
caseinate; 25-50% by weight of protein selected from the group consisting of whey protein, soy
protein, pea protein potato protein and combinations thereof; and 50 to 75% by weight of nonmicellar
milk protein isolate, non-micellar milk protein concentrate or a combination thereof.
Claim 4. A low viscosity, high caloric density liquid nutritional composition according to
claim 1, wherein the non-micellar protein is denatured through one or more of hydrolysis, heat
treatment, homogenization, or reaction with soluble divalent minerals.
Claim 5. A low viscosity, high caloric density liquid nutritional composition according to
any one of claims 1-4, wherein the emulsifier is lecithin and the lecithin is present in an amount
of between 0.5 and 5% by weight based on the total amount of fat in the nutritional composition.
Claim 6. A low viscosity, high caloric density liquid nutritional composition according to
claim 5, wherein the lecithin is selected from the group consisting of soy lecithin, sunflower
lecithin, milk phospholipid, or combinations thereof.
Claim 7. A low viscosity, high caloric density liquid nutritional composition according to
claim 5, wherein the soy lecithin or sunflower lecithin is natural, refined or chemically modified.
Claim 8. A low viscosity, high caloric density liquid nutritional composition according to
any one of claims 1-4 further comprising a stabilizer selected from the group consisting of
octenyl succinic anhydride, gellan gum, alginate, pectin, guar gum, locust bean gum, konjack,
carboxymethyl cellulose, microcrystalline cellulose, and combinations thereof.
Claim 9. A low viscosity, high caloric density liquid nutritional composition comprising:
a) protein in amount of between 8 to 27 grams per 100 mL of the nutritional composition;
b) fat in an amount of between 0 and 17 grams per 100 mL of the nutritional supplement;
c) an anti-foaming agent selected from the group consisting of simethicone,
dimethylpolysiloxane, silicone dioxide, lecithin, milk phospholipid, and combinations thereof;
and
e) a chelating agent selected from the group consisting of monovalent chelating agents,
divalent chelating agents, and combinations thereof; in an amount of 0.3 weight % to 0.5 weight
%;
wherein the nutritional composition has a viscosity of between 45 and 140 cps; wherein the
protein comprises non-micellar milk protein isolate or non-micellar milk protein concentrate and
a hydrolyzed caseinate; wherein the composition has a caloric density of 200 to 300 kcal per 100
mL of the nutritional supplement; and wherein the total combined amount of fat and protein is 8-
27 grams per 100 mL of the nutritional composition.
Claim 10. A low viscosity, high caloric density liquid nutritional composition according to
claim 9, wherein the chelating agent is selected from the group consisting of calcium citrate,
magnesium citrate, magnesium phosphate, calcium phosphate, monocalcium phosphate, and
combinations thereof.
Claim 11. A low viscosity, high caloric density liquid nutritional composition according to
claim 9 or 10 wherein the anti-foaming agent is selected from the group consisting of
simethicone, dimethylpolysiloxane, silicone dioxide, lecithin, milk phospholipid, and
combinations thereof.
Claim 12. A low viscosity, high caloric density liquid nutritional composition according to
claim 9 or 10, where the protein comprises: 50-75% by weight of non-micellar milk protein
isolate, non-micellar milk protein concentrate or a combination thereof; and
0 - 50% by weight of partially hydrolyzed caseinate; or
0-25%o by weight of partially hydrolyzed caseinate; and 0-25% by weight of at
least one protein selected from the group consisting of: micellar milk protein, nonhydrolyzed
caseinate, soy, pea, whey, rice, corn, meat, fish, egg albumen, potato, canola,
algal protein, mycoprotein and combinations thereof.
Claim 13. A low viscosity, high caloric density liquid nutritional composition according to
claim 12, wherein the non-micellar protein is denatured through one or more of: hydrolysis, heat
treatment, homogenization, or reaction with soluble divalent minerals.
Claim 14. A low viscosity, high caloric density liquid nutritional composition according to
any one of claims 9-13 , wherein the anti-foaming agent is present in an amount of between 0.6
and 6% by weight based on the total amount of fat in the nutritional composition.
Claim 15. A low viscosity, high caloric density liquid nutritional composition according to
any one of claims 9-13 where the anti-foaming agent is simethicone, dimethylpolysiloxane or
silicone dioxide and the anti-foaming agent is present in an amount of between 0.6 and 6 % by
weight of the nutritional composition.
Claim 16. A low viscosity, high caloric density liquid nutritional composition according to
claim 9, wherein the chelating agent is selected from the group consisting of divalent citrates,
and divalent phosphates.
Claim 17. A low viscosity, high caloric density liquid nutritional composition according to
claim 9, wherein the chelating agent is selected from the group consisting of monovalent
chelating agents, divalent chelating agents, and combinations thereof.
Claim 18. A method for the manufacture of a stable, low viscosity, high caloric density
liquid nutritional composition comprising:
a) combining fat and at least one emulsifier selected from the group consisting of lecithin,
monoglycerides, diglycerides, polyglycerol esters, milk phospholipids, citric acid esters,
datem, emulsifiers with a hydrophobic-lipophilic balance between 5 and 16, and
combinations thereof to make a first mixture, wherein the first mixture is free of water;
b) combining 5-20% by weight of the first mixture with water in a ratio of 1:110 to 1:20
to make a second mixture;
c) adding protein comprising non-micellar milk protein and partially hydrolyzed
caseinate to the second mixture to make a third mixture, wherein the non-micellar milk
protein is selected from the group consisting of non-micellar milk protein isolate, nonmicellar
milk protein concentrate, and combinations thereof; and
d) combining the third mixture with the remainder of the first mixture to make a fourth
mixture,
wherein the fourth mixture is mixed with one or more carbohydrates, vitamins and
minerals to produce a liquid nutritional composition having a viscosity of 45-140 cps, 8
to 27 grams of protein per 100 mL, 0 to 17 grams of fat per 100 mL and a total amount of
protein and fat of 8-27 grams per 100 mL.
Claim 19. A method according to claim 18 wherein the partially hydro lyzed caseinate is
selected from the group consisting of sodium caseinate, potassium caseinate, magnesium
caseinate, calcium caseinate, and combinations thereof.
Claim 20. A method according to claim 18, wherein the protein comprises 50-75%
nonmicellar milk protein; and
0 - 50% by weight of partially hydrolyzed caseinate; or
0-25% by weight of partially hydrolyzed caseinate; and 0-25% by weight of at
least one protein selected from the group consisting of: micellar milk protein, nonhydrolyzed
caseinate, soy, pea, whey, rice, corn, meat, fish, egg albumen, potato, canola,
algal protein, mycoprotein and combinations thereof.
Claim 21. A method according to any one of claims 18-20, wherein the emulsifier is lecithin
and the lecithin is present in an amount of 0.5 to 5 weight %, based on the total amount of fat
Claim 22. A method according to any one of claims 18-20, wherein the nonmicellar protein
is denatured through one or more of: hydrolysis, heat treatment, homogenization, or reaction
with soluble divalent minerals, and combinations thereof.
Claim 23. A method according to any one of claims 18-20, wherein the emulsifier is lecithin
and the lecithin is added to the first mixture in an amount of from 0.5 to 2% by weight based on
the total weight of fat.
Claim 24. The method according to any one of claims 18-20, wherein the final mixture has a
viscosity of between 45 and 125 cps.
The method according to any one of claims 18-20, wherein the final mixture has
protein content of between 8 and 17 g per lOOmL of the final mixture.
| # | Name | Date |
|---|---|---|
| 1 | 5494-DELNP-2015-FER.pdf | 2019-11-29 |
| 1 | PD016639IN-NP - SPEC FOR FILING.pdf | 2015-06-24 |
| 2 | PD016639IN-NP - FORM 5.pdf | 2015-06-24 |
| 2 | Description(Complete) [21-12-2016(online)].pdf | 2016-12-21 |
| 3 | PD016639IN-NP - FORM 3.pdf | 2015-06-24 |
| 3 | Description(Complete) [21-12-2016(online)].pdf_115.pdf | 2016-12-21 |
| 4 | Form 13 [21-12-2016(online)].pdf | 2016-12-21 |
| 4 | Abbott Laboratories,_new GPOA.pdf | 2015-06-24 |
| 5 | Marked Copy [21-12-2016(online)].pdf | 2016-12-21 |
| 5 | 5494-DELNP-2015.pdf | 2015-06-25 |
| 6 | Form 18 [13-12-2016(online)].pdf | 2016-12-13 |
| 6 | 5494-delnp-2015-Correspondence Others-(16-11-2015).pdf | 2015-11-16 |
| 7 | 5494-delnp-2015-Correspondence Others-(18-12-2015).pdf | 2015-12-18 |
| 7 | 5494-delnp-2015-Assignment-(16-11-2015).pdf | 2015-11-16 |
| 8 | 5494-delnp-2015-Form-3-(18-12-2015).pdf | 2015-12-18 |
| 9 | 5494-delnp-2015-Correspondence Others-(18-12-2015).pdf | 2015-12-18 |
| 9 | 5494-delnp-2015-Assignment-(16-11-2015).pdf | 2015-11-16 |
| 10 | 5494-delnp-2015-Correspondence Others-(16-11-2015).pdf | 2015-11-16 |
| 10 | Form 18 [13-12-2016(online)].pdf | 2016-12-13 |
| 11 | Marked Copy [21-12-2016(online)].pdf | 2016-12-21 |
| 11 | 5494-DELNP-2015.pdf | 2015-06-25 |
| 12 | Form 13 [21-12-2016(online)].pdf | 2016-12-21 |
| 12 | Abbott Laboratories,_new GPOA.pdf | 2015-06-24 |
| 13 | PD016639IN-NP - FORM 3.pdf | 2015-06-24 |
| 13 | Description(Complete) [21-12-2016(online)].pdf_115.pdf | 2016-12-21 |
| 14 | PD016639IN-NP - FORM 5.pdf | 2015-06-24 |
| 14 | Description(Complete) [21-12-2016(online)].pdf | 2016-12-21 |
| 15 | PD016639IN-NP - SPEC FOR FILING.pdf | 2015-06-24 |
| 15 | 5494-DELNP-2015-FER.pdf | 2019-11-29 |
| 1 | 5494search_29-11-2019.pdf |