ASEPTICALLY PACKAGED NUTRITIONAL
LIQUIDS COMPRISING HMB
FIELD OF THE DISCLOSURE
PCT/US2011/022932
[000 I] The present disclosure relates to aseptically packaged nutritional liquids
comprising beta-hydroxy-beta-methylbutyrate (HMB).
BACKGROUND OF THE DISCLOSURE
[0002] There are many different types of packaged nutritional liquids suitable for
oral administration to humans, which compositions typically comprise various
combinations of macro and micro nutrients. Many of these packaged liquids are formulated
as milk or protein-based emulsions for use as sole or supplemental sources of nutrition.
These packaged emulsions are often manufactured as oil-in-water emulsions comprising
fat, protein, carbohydrate, vitamins, and minerals, some examples of which include
ENSURE® Nutritional Liquid and GLUCERNA® Shakes available from Abbott
Laboratories, Columbus, Ohio USA.
[0003] During the manufacturing process, these packaged nutritional
compositions are sterilized to reduce microbial contaminants to the extent necessary to
render the compositions suitable for oral administration to humans. These processes often
include thermal processes such as retort sterilization and aseptic process sterilization. A
typical retort process involves introducing the nutritional composition into a suitable
container, sealing the container. and then heating the sealed container and its contents for a
time period and at temperature sufficient for sterilization. An aseptic sterilization process
on the other hand typically involves separately sterilizing the interior of a food grade
container and a nutritional composition and then combining the sterilized container and the
sterilized nutritional composition in a clean room environment and sealing the container.
[0004] Aseptic sterilization processes for sterilizing nutritional compositions have
grown in popularity over the years. By using such processes, nutritional products do not
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have to be heated to a temperature as high as that required for retort sterilization. These
lower temperatures are generally preferred as they result in a decreased amount of product
oxidation as compared to higher temperatures. Additionally. aseptic sterilization of plastic
containers is generally preferred over retort sterilization of plastic containers as retort
sterilization requires high temperature heating of the plastic container which can result in
fail urc of the plastic container during sterilization.
[0005] Although aseptic sterilization has grown in popularity and has several
advantages over retort sterilization, aseptic sterilization does require that the interior of the
container be sterilized prior to the introduction of the sterilized nutritional composition.
This interior sterilization is often performed by introducing a peroxide-containing solution,
such as a hydrogen peroxide solution. typically in atomized form. into at least the interior of
the container and drying the solution to produce a sterilized surface. Irrespective of the
drying process employed, peroxide residue remains on the interior surface of the container.
This residue can be problematic in some applications as it can. over time, migrate into the
nutritional composition and cause a reduction in pH ofthe nutritional composition
subsequently introduced into the peroxide-treated container.
[0006] The reduction in pH of the nutritional liquid over time due to oxidation can
have numerous detrimental effects on the nutritional liquid inside the package including:
(I) increasing the release of bound minerals, which in ionic form can compromise stability
of the nutritional liquid due to precipitation; (2) increasing the amount of catalytic
oxidation, particularly of iron and copper species; (3) increasing the amount of protein
precipitation; and ( 4) increasing vitamin C destabilization. Any one of these unwanted
effects can significantly reduce the commercial acceptability of the nutritional liquid.
[0007] There is therefore a need for stable nutritional compositions, such as stable
protein or milk-based liquids or emulsions. that can be introduced into peroxide-treated
aseptically sterilized containers and that arc stable and resistant to a reduction in pH over
time.
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SUMMARY OF THE DISCLOSURE
[0008] The present disclosure is directed to a composition comprising a peroxidetreated
aseptic package and a nutritional liquid contained or hermetically sealed therein. the
nutritional liquid comprising beta-hydroxy-beta-methyl butyrate and at least one of fat,
carbohydrate, and protein. The peroxide-treated package as referred to herein may be a
package that has been subjected to peroxide-based aseptic treatment, or merely a package
that otherwise contains a peroxide residue prior to, during, and or after combination with a
nutritional liquid, regardless of the process or circumstance by which such peroxide
materials were introduced to the package.
[00091 Peroxide residues when used to characterize the package component may
range up to an acceptable amount or level that is suitable for use in a nutritional product in
the country or region within which the product is sold. Such peroxide levels are most
typically less than 0.5 ppm. including from about 0.00 I to about 0.5 ppm, and also
including from about 0.05 to about 0.1 ppm, by weight of nutritional liquid combined with
or contained within the package.
[00 1 0] The present disclosure is further directed to a method of preparing a pHstable
nutritional liquid in a peroxide-treated aseptic package. The method comprises
combining a fat, protein, carbohydrate and beta-hydroxy-beta-methylbutyrate together to
form a nutritional liquid, sterilizing the nutritional liquid, sterilizing aseptically a package
by treating at least the interior of the package with a peroxide-containing solution, and
introducing the sterilized nutritional liquid into the aseptically sterilized package.
[00 11] It has been discovered that the addition of beta-hydroxy-betamethylbutyrate
(l-IMB) into nutritional liquids, such as nutritional emulsions, imparts a
buffering effect to the nutritional liquid such that the nutritional liquid is more resistant to
pH change upon a shift in hydrogen ion concentration. This unexpected effect is
advantageous in that HMB is a desirable additive to nutritional compositions and, based on
the discovery now made. can now be added to nutritional liquids so that the nutritional
liquids can be packaged in containers that have been aseptically sterilized utilizing a
peroxide-containing solution so that the resulting nutritional liquid is more pH-stable due to
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the buffering effect of the HMB present in the solution. Because nutritional liquids
introduced into containers aseptically sterilized utilizing a peroxide-containing solution are
by nature more subject to a shitl in pH over time as discussed above. the unexpected
discovery of the buffering effect of HMB in a nutritional liquid is particularly useful for
nutritional liquids that are introduced into containers that have been aseptically sterilized
utilizing a peroxide-containing solution.
DETAILED DESCRIPTION OF THE ()ISCLOSURE
[00 12] The packaged nutritional compositions of the present disclosure may
comprise HMB and at least one of fat, protein, and carbohydrate, and may also include one
or more optional or other components, features, or ingredients. The essential features of the
nutritional liquids, as well as some ofthe many optional variations, are described in detail
hereafter.
[00 13] The term ''HMB" as used herein, unless otherwise specified, refers to betahydroxy-
beta-methylbutyratc (also referred to as beta-hydroxyl-3-methyl butyric acid, betahydroxy
isovaleric acid) or a source thereof such as a calcium salt of HMB. When the
source of HMB is calcium HMB. this particular source is most typically a monohydrate so
that all weights. percentages. and concentrations as used herein and directed to calcium
HMB are based on the weight of calcium HMB monohydrate, unless otherwise specified.
[0014] The term "nutritional liquid" as used herein, unless otherwise specified,
means formulations comprising at least one of fat, protein. and carbohydrate, which are
suitable for oral administration to a human and have a drinkable viscosity at the intended
administration temperature, which is most typically from about I oc to about 25°C. In this
context. a drinkable viscosity at the target temperature would typically be less than about
300 cps. more typically from about I 0 cps to about 160 cps. and even more typically from
about 20 cps to about 70 cps. Viscosity values as used herein, unless otherwise specified,
are obtained using a Brookfield Viscometer (Model DV-11+) with a 62 spindle at the target
temperature. The viscosity is measured by operating the viscometer at a spindle speed that
is the highest speed possible to obtain a reading that is on scale. The measured viscosity
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values represent the ratio of shear stress to shear rate, expressed as dynes-second/cm2
, or
poise, or more typically as centipoise (cps) or one hundredth of a poise.
[0015] The term "shelf stable" as used herein, unless otherwise specified, refers to
a nutritional liquid that can remain commercially stable after being packaged and then
stored at 18-25°C tor at least about 3 months, including from about 6 months to about 24
months, and also including from about 12 months to about 18 months.
[0016] The term "nutritional emulsion" as used herein, unless otherwise specified,
means nutritional liquids formulated as aqueous emulsions, including water-in-oil, oil-inwater.
and complex emulsions. but most typically oil-in-water emulsions.
[0017] The terms ··fat" and ''oil" as used herein. unless otherwise specified, are
used interchangeably to refer to lipid materials derived or processed from plants or animals.
These terms also include synthetic lipid materials so long as such synthetic materials are
suitable for oral administration to humans.
[00 18] The term ''pH-stable" as used herein, unless otherwise specified, means
that the pH is resistant or at least more resistant to pH reductions due to a buffering effect
of beta-hydroxy-beta-methyl butyrate.
[00 19] The term ''plastic" as used herein, unless otherwise specified, means food
grade plastics approved by the U.S. Food and Drug Administration or other suitable
regulatory group, some non-limiting examples of which include polyvinyl chlorides.
polyethylene terephthalate, high density polyethylene, polypropylenes, polycarbonates, and
so forth.
[0020] The terms "sterile", ·'sterilized" or "sterilization" as used herein, unless
otherwise specified, refers to the reduction in transmissible agents such as fungi, bacteria,
viruses, spore forms, and so forth. in food or on food grade surfaces to the extent necessary
to render such foods suitable for human consumption. Sterilization processes may include
various techniques involving the application of heat. peroxide or other chemicals.
irradiation. high pressure. filtration. or combinations or variations thereof.
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[0021] All percentages, parts and ratios as used herein, are by weight of the total
composition, unless otherwise specified. All such weights as they pertain to listed
ingredients are based on the active level and, therefore, do not include solvents or byproducts
that may be included in commercially available materials, unless otherwise
specified.
[0022] 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.
[0023] 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.
[0024] The various embodiments of the nutritional emulsions ofthe present
disclosure may also be substantially free of any optional or selected essential ingredient or
feature described herein, provided that the remaining nutritional emulsion still contains all
of the required ingredients or features as described herein. In this context, and unless
otherwise specified. the term "substantially free" means that the selected nutritional
emulsion contains less than a functional amount of the optional ingredient, typically less
than about 0.5% by weight. including less than about 0.1% by weight, and also including
zero percent by weight, of such optional or selected essential ingredient.
[0025] The nutritional liquids and corresponding manufacturing methods ofthe
present disclosure can comprise, consist of, or consist essentially of the essential elements
and features of the disclosure as described herein. as well as any additional or optional
ingredients, features, or elements described herein or otherwise useful in nutritional
applications.
Product Form
[0026] The nutritional liquids of the present disclosure comprise at least one of
fat, protein, and carbohydrate, which are suitable for oral administration to a human and
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have a drinkable viscosity at the intended administration temperature. These compositions
are most typically formulated as emulsions such as oil-in-water, water-in-oil, or complex
aqueous emulsions, and even more typically as oil-in-water emulsions having a continuous
aqueous phase and a discontinuous oil phase. The nutritional liquids may be shelf-stable.
[0027] The nutritional liquids may also be characterized as ready-to-feed or readyto-
drink liquids, which means that the liquids are packaged in liquid form and are suitable
for consumption as such immediately upon removal from the closed plastic container
holding the liquid. In other words, the present disclosure does not contemplate nutritional
powders or other compositions that are formulated or otherwise reconstituted and are
required to be used within 24-72 hours following formulation or reconstitution.
[0028] Although the nutritional liquids are most typically in the form of shelf
stable emulsions, these liquids may also be formulated as non-emulsions such as solutions,
suspensions (suspended solids), gels and so forth. These nutritional liquid may also be
formulated as non-shelf stable products requiring refrigeration to maintain an extended
shelf life.
[0029] The nutritional liquids typically contain up to about 95% by weight of
water, including from about 50% to about 95%, also including from about 60% to about
90%. and also including from about 70% to about 85%, of water by weight ofthe
nutritional liquids.
[0030] The nutritional liquids may be formulated with sufficient kinds and
amounts of nutrients so as to provide a sole, primary, or supplemental source of nutrition,
or to provide a specialized nutritional liquid for use in individuals afflicted with specific
diseases or conditions. These nutritional compositions may have a variety of product
densities, but most typically have a density greater than about 1.055 g/ml, including from
1.06 g/ml to 1.12 g/ml. and also including from about 1.085 g/ml to about 1.10 g/ml.
[0031] The nutritional liquids may have a caloric density tailored to the nutritional
needs of the ultimate user, although in most instances the compositions comprise from
about 100 to about 500 kcal/240 ml, including from about 150 to about 350 kcal/240 ml,
and also including from about 200 to about 320 kcal/240 mi. These nutritional
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compositions also comprise HMB as described herein, the amount of which most typically
ranges from about 0.5 to about 3.0 g/240 mi. including from about 0.75 to about 2.0 g/240
mi. including about 1.5 g/240 mi.
[0032] The nutritional liquids may have a pH ranging from about 3.5 to about 8,
but are most advantageously in a range of from about 4.5 to about 7.5, including from about
5.5 to about 7.3, including from about 6.2 to about 7.2.
[0033] Although the serving size for the nutritional emulsion can vary depending
upon a number of variables, a typical serving size ranges from about l 00 to about 300 ml,
including from about 150 to about 250ml. including from about 190 ml to about 240 mi.
Beta-Hvdroxy-Beta-McthviButyratc (HMB)
[0034] The nutritional liquids comprise HMB or any source thereof that is suitable
for use in an oral nutritional product and is otherwise compatible with the essential
elements or features of the nutritional liquids.
[0035] The nutritional liquids most suitably comprise a calcium salt ofHMB,
which calcium salt is most typically in a monohydrate form. Although calcium HMB or
calcium HMB monohydrate is the preferred source of HMB for use herein, other suitable
sources may include HMB as the free acid, other salt forms including an anhydrous salt, an
ester. a lactone. or other product forms that otherwise provide a bioavailable form of HMB
from the nutritional liquid. Non-limiting examples of suitable salts ofHMB for use herein
include HMB salts. hydrated or anhydrous. of sodium. potassium. magnesium, chromium,
calcium, or other non-toxic salt form. Calcium HMB monohydrate is preferred and is
commercially available from Technical Sourcing International (TSI) of Salt Lake City,
Utah.
[0036] The concentration of calcium HMB, including the concentration of
calcium HMB and or calcium HMB monohydrate when such are used as the HMB source
herein. in the nutritional liquids may range up to about 10%, including from about 0.1% to
about 8%. and also including from about 0.2% to about 5.0%. and also including from
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about 0.3% to about 3%, also including from about 0.4% to about 1.5%, and also including
about 0.45% by weight of the nutritional liquid.
Macronutrients
[0037] The nutritional liquids comprise. in addition to HMB, at least one of fat,
protein. and carbohydrate. Generally. any source of fat, protein, and carbohydrate that is
known or otherwise suitable for use in nutritional products may also be suitable for use
herein, provided that such macronutrients are also compatible with the essential elements of
the nutritional liquids as defined herein.
[0038] Although total concentrations or amounts of the fat, protein, and
carbohydrates may vary depending upon the nutritional needs of the intended user, such
concentrations or amounts most typically fall within one of the following embodied ranges,
inclusive of other fat. protein. and or carbohydrate ingredients as described herein.
[0039] Carbohydrate concentrations most typically range from about 5% to about
40%, including from about 7% to about 30%, including from about I 0% to about 25%, by
weight of the nutritional liquid; fat concentrations most typically range from about I% to
about 30%. including from about 2% to about 15%. and also including from about 4% to
about I 0%. by weight of the nutritional liquid; and protein concentrations most typically
range from about 0.5% to about 30%, including from about I% to about 15%. and also
including from about 2% to about I 0%, by weight of the nutritional liquid.
[0040] The level or amount of carbohydrates, fats. and or proteins in the
nutritional liquids may also be characterized in addition to or in the alternative as a
percentage oftotal calories in the nutritional liquids as set forth in the following table.
Nutrient(% Calories) Embodiment A Embodiment B Embodiment C
Carbohydrate 1-98 10-75 30-50
Fat 1-98 20-85 35-55
Protein 1-98 5-70 15-35
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(0041] Non-limiting examples of suitable fats or sources thereof for use in the
nutritional liquids described 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, marine oils, cottonseed oils, and combinations thereof.
(0042] Non-limiting examples of suitable carbohydrates or sources thereof for use
in the nutritional liquids described herein may include maltodextrin. hydrolyzed or
modified starch or cornstarch, glucose polymers, corn syrup, corn syrup solids, rice-derived
carbohydrates, glucose, fructose. lactose, high fructose corn syrup, honey, sugar alcohols
(e.g., maltitol, erythritol, sorbitol), and combinations thereof.
[0043] Non-limiting examples of suitable protein or sources thereof for use in the
nutritional liquids include hydrolyzed, partially hydrolyzed or non-hydrolyzed proteins or
protein sources, which may be derived from any known or otherwise suitable source such
as milk (e.g .. casein. whey), animal (e.g .. meat, fish). cereal (e.g., rice, com), vegetable
(e.g., soy) or combinations thereof. Non-limiting examples of such proteins include milk
protein isolates, milk protein concentrates as described herein, casein protein isolates, whey
protein, sodium and calcium caseinates, whole cow's milk, partially or completely defatted
milk, soy protein isolates, soy protein concentrates. and so forth.
[0044] The nutritional liquids are particularly useful when formulated with a fat
component as described herein since such ingredients may readily oxidize in an aqueous
emulsion over time, thus generating increasing hydrogen ion concentrations over time that,
absent the use ofHMB or other buffering system herein, may result in a decrease in the
composition pH and consequently a reduction in product stability.
Soluble Protein
[0045] The nutritional liquids of the present disclosure may comprise selected
amounts of soluble protein to improve product stability and minimize the development of
bitter flavors and after taste over time.
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[0046] The soluble protein may represent from about 35% to 100%, including
from about 40% to about 85%, including from about 60% to about 80%, and also including
from about 65% to about 75%, by weight of the total protein in the nutritional liquid. The
concentration of soluble protein may range from at least about 0.5%. including from about
1% to about 26%. and also including from about 2% to about 15%. also including from
about 3% to about 10%, and also including from about 4% to about 8%, by weight ofthe
nutritional liquid.
[0047] The amount of soluble protein included in the nutritional liquids may also
be characterized as a weight ratio of soluble protein to HMB. wherein the nutritional liquid
includes a weight ratio of soluble protein to HMB, including calcium HMB and or calcium
HMB monohydrate, of at least about 3.0, including from about 4.0 to about 12.0, also
including from about 7.0 to about 11.0. and also including from about 8.0 to about 10.0.
[0048] The term "soluble protein" as used herein. unless otherwise specified,
refers to those proteins having a solubility of at least about 90% as measured in accordance
with a Protein Solubility Measurement Test that includes the following steps: (1) suspend
the protein at 2.00% (w/w) in water; (2} stir vigorously for one hour at 20°C to form a
suspension; (3) remove an aliquot of the suspension, and detem1ine protein concentration as
total protein; (4) centrifuge the suspension at 31.000 x g and at 20°C for one hour; (5)
determine the protein concentration in the supernatant (the soluble protein); and (6) express
the soluble protein as a percentage of the total protein.
[0049] Any soluble protein source is suitable for use herein provided that it meets
the solubility requirement as defined herein. some non-limiting examples of which include
sodium caseinate (>95% solubility as determined by the Protein Solubility Measurement
Test), whey protein concentrate (>90% solubility as determined by the Protein Solubility
Measurement Test), and combinations thereof. Non-soluble proteins may of course also be
included in the nutritional emulsions.
[0050] Soluble protein suitable for use herein may also be characterized by the
content of phosphoserine in the protein, wherein the soluble proteins in this context are
defined as those proteins having at least about 100 mmoles. including from about 150 to
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400 mmoles. including from about 200 to about 350 mmoles. and also including from about
250 to about 350 mmoles, ofphosphoserine per kilogram ofprotein.
[0051] When the soluble protein is defined in terms of phosphoserine content, it
has been found that the weight ratio of the soluble protein (with the defined phosphoserine
content) to the calcium HMB may be at least about 3:1, including at least about 5:1, and
also including at least about 7: I. and also including from about 9: I to about 30: I. In this
context, the proteins having the requisite content of phosphoserine are most typically in the
form of monovalent caseinate salts such as sodium caseinate, potassium caseinate, and
combinations thereof.
[0052] In one embodiment. the soluble protein may also be characterized by a
mole ratio of monovalent caseinate phosphoserine to calcium HMB monohydrate of least
about 0.2, including from about 0.2 to about 2.0, and also including from about 0.25 to 1.7.
[0053] It should be understood, however, that any phosphoserine-containing
protein may be suitable for use herein provided that it has the requisite phosphoserine
content and that the phosphoserinc used in calculating the ratios are not bound, complexed,
or otherwise attached to a polyvalent cation such as calcium or magnesium.
[0054] It should also be noted that alternative definitions as described herein for
soluble proteins may include proteins that have little or no phosphoserine content, so that
the soluble protein fraction of the compositions may include soluble protein with and/or
without phosphoserine. The soluble protein for use herein may therefore be defined by any
one or more of the soluble protein characterizations, separately or in combination.
[0055] The phosphoserine moieties within the protein may therefore be available
for binding with the calcium released from the calcium HMB so that the above ratios of
soluble protein to calcium HMB are the ratio of protein with phosphoserinc moities that are
unbound. unattached, or otherwise available to bind soluble calcium from the calcium
HMB during formulation. It could be, for example. that a mixture of calcium caseinate and
sodium caseinate are used in the composition. but the ratio of proteins defined by a
phosphoserine content to calcium HMB is calculated based on the protein fraction from the
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sodium caseinate and additionally any protein from the calcium caseinate fraction that is
not bound to calcium.
Soluble Calcium Binding Capacity
[0056] The nutritional compositions of the present disclosure may include
emulsion embodiments comprising a selected weight ratio of a soluble calcium binding
capacity (SCBC) to the total soluble calcium in the emulsion to improve product stability
and minimize the development over time of bitter flavors and after taste.
[0057] The ratio of the soluble calcium binding capacity (defined herein) to total
soluble calcium of the emulsions embodiments is a weight ratio of at least about 2.3,
including from about 2.3 to about 12.0, also including from about 3.0 to about 8.0, and also
including from about 4.0 to about 6.5, wherein the ratio is determined in accordance with
the following formulas:
Ratio= SCBC I [soluble calcium]
SCBC = (0.32 x [soluble citrate]+ 0.63 [soluble phosphate]+ 0.013 x [soluble protein])
[0058] The weight ratio of SCBC to the concentration of total soluble calcium can
be adjusted to minimize the concentration of unbound calcium in the nutritional emulsion,
or to minimize the weight ratio of such unbound calcium to HMB in the emulsions, to
improve product stability and reduce the development over time of bitter flavors and after
tastes.
Calcium
[0059] The nutritional liquids of the present disclosure may further comprise
calcium as desirable for use in developing or maintaining healthy muscle in targeted
individuals. Some or all of the calcium may be provided when calcium HMB or calcium
HMB monohydrate is used as the HMB source. Any other calcium source, however, may
be used provided that such other source is compatible with the essential elements of the
nutritional liquids.
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[0060] The concentration of calcium in the nutritional liquids may exceed about
1 Omg/L, and may also include concentrations of from about 25mg/L to about 3000 mg!L,
also including from about 50mg/L to about 500 mg/L. and also including from about
1 OOmg/L to bout 300mg/L.
[0061] To minimize the taste and stability issues in the emulsion embodiments
hereof. the calcium may be formulated so as to minimize the extent to which the calcium is
solubilized in the emulsions. As such. solubilized calcium concentrations in the emulsion
embodiments may be less than about 900 mg/L, including less than about 700mg/L, also
including from about 500mg/L to about 700mg/L, and also including from about 400mg/L
to about 600 mg/L. In this context. the term "solubilized calcium" refers to supernatant
calcium in the nutritional liquids as measured at 20°C.
[0062] The calcium in the liquids may also be characterized by a ratio (on an
equivalents basis) of solubilized citrate to solubilized calcium of not more than 5.0.
including not more than 4.0, also including not more than 3.0, and also including from
about 0.8 to about 3.0. In this context. the terms "solubilized citrate" and "solubilized
calcium" refers to the equivalents of citrate and calcium cations, respectively, present in the
supernatants of nutritional liquids as measured at 20°C.
[0063] The calcium component of the nutritional liquids may also be
characterized by a solubilized calcium level that represents less than 900 mg/L, including
less than 700 mg/L, and also including less than 600 mg/L, and also including from 400
mg/L to 700 mg/L of the nutritional emulsion. wherein the weight ratio of calcium HMB or
its monohydrate form to the solubilized calcium ranges from about 6 to about 15, including
from about 6 to about 12. also including from about 6 to about 10, and also including from
about 6 to about 8.
Vitamin D
[0064] The nutritional compositions of the present disclosure may further
comprise vitamin D to help maintain healthy muscle in the targeted user. Vitamin D forms
include Vitamin 02 (ergocalciferol) and Vitamin 03 (cholecalciferol) or other forms
suitable for use in a nutritional product.
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The amount of Vitamin D in the nutritional liquid most typically ranges up to about 1000
IU, more typically from about l 0 to about 600 IU, and more typically from about 50 to
400 IU per serving size.
Optional Ingredients
[0065] The nutritional liquids may further comprise other optional ingredients that
may modify the physical. chemical, hedonic or processing characteristics of the products or
serve as pham1aceutical or additional nutritional components when used in the targeted
population. Many such optional ingredients are known or otherwise suitable for use in
other nutritional products and may also be used in the nutritional liquids described herein,
provided that such optional ingredients are safe and effective for oral administration and are
compatible with the essential and other ingredients in the selected product form.
[0066] Non-limiting examples of such optional ingredients include preservatives,
antioxidants, emulsifying agents, additional buffers. pharmaceutical actives, additional
nutrients as described herein, colorants, flavors, thickening agents and stabilizers, and so
forth.
[0067] The nutritional liquids may further comprise vitamins or related nutrients,
non-limiting examples of which include vitamin A, vitamin E. vitamin K, thiamine,
riboflavin, pyridoxine, vitamin 8 12. carotcnoids, niacin, folic acid, pantothenic acid, biotin.
vitamin C, choline, inositol. salts. and derivatives thereof, and combinations thereof.
[0068] The nutritional liquids may further comprise minerals. non-limiting
examples of which include phosphorus, magnesium, iron, zinc. manganese, copper, sodium,
potassium, molybdenum, chromium, selenium, chloride, and combinations thereof.
[0069] The nutritional liquids may also include one or more masking agents to
reduce or otherwise obscure the development of residual bitter flavors and after taste in the
liquids 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, gcllan gum. and combinations thereof. The amount of masking agents in the
nutritional liquids may vary depending upon the particular masking agent selected, other
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ingredients in the formulation, and other formulation or product target variables. Such
amounts, however, most typically range from at least about 0.1 %, including from about
0.15% to about 3.0%. and also including from about 0.18% to about 2.5%. by weight of the
nutritional liquid.
Method of Usc
[0070] The nutritional liquids described herein are useful to provide supplemental,
primary. or sole sources of nutrition. and or to provide individuals one or more benefits as
described herein. In accordance with such methods, the liquids may be administered orally
as needed to provide the desired level of nutrition, most typically in the form of one to two
servings daily, in one or two or more divided doses daily, e.g., serving sizes typically
ranging from about I 00 to about 300 mi. including from about 150 to about 250m I,
including from about 190 ml to about 240 mi. wherein each serving contains from about 0.4
to about 3.0 g. including from about 0. 75 to about 2.0 g, including about 1.5 g, of calcium
l-IMB per serving.
[0071] Such methods are further directed to provide the individual upon
administration of such products. most typically after daily use over an extended period of
time of from about I to about 6 months. including from about I to about 3 months, one or
more of I) to support maintenance of lean body mass, 2) to support of strength and or
muscle strength. 3) to decrease protein breakdown and damage of muscle cells, 4) to help
with muscle recovery following exercise or other trauma, and 5) to reduce muscle protein
breakdown following exercise.
[0072] Such methods arc also helpful to achieve one or more of I) to maintain and
support lean body mass in elderly with sarcopenia. 2) to provide nutrition to support an
active and independent lifestyle in individuals. especially in the elderly, 3) to support
recovery of muscle strength, 4) to help rebuild muscle and regain strength, and 5) to
improve strength, including muscle strength. and mobility.
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Methods of Manufacture
[0073] The nutritional liquids may be manufactured by any known or otherwise
suitable method for making nutritional emulsions or other liquids, most typically for
making nutritional aqueous emulsions or milk based emulsions.
[0074] In one suitable manufacturing process, for example, at least three
separate slurries are prepared, including a protein-in-fat (PIF) slurry, a carbohydratemineral
(CHO-MIN) slurry, and a protein-in-water (PIW) slurry. The PIF slurry is formed
by heating and mixing the selected oils (e.g .. canola oil. com oil. etc.) and then adding an
emulsifier (e.g., lecithin). fat soluble vitamins. and a portion of the total protein (e.g., milk
protein concentrate, etc.) with continued heat and agitation. The CHO-MIN slurry is
formed by adding with heated agitation to water: minerals (e.g .. potassium citrate,
dipotassium phosphate, sodium citrate, etc.). trace and ultra trace minerals (TM/UTM
premix), thickening or suspending agents (e.g. Aviccl, gellan, carrageenan), and calcium
l-IMB or other l-IMB source. The resulting Cl-IO-MIN slurry is held for I 0 minutes with
continued heat and agitation before adding additional minerals (e.g .. potassium chloride,
magnesium carbonate. potassium iodide, etc.), carbohydrates (e.g .• frucotooligosaccharide,
sucrose, com syrup, etc.). The PIW slurry is then formed by mixing with heat and
agitation the remaining protein (e.g .. sodium caseineate, soy protein concentrate. etc.) into
water.
[0075) The resulting slurries are then blended together with heated agitation and
the pH adjusted to the desired range, typically 6.6-7 .0. after which the composition is
subjected to high-temperature short-time (HTST) processing during which the composition
is heat treated, emulsified and homogenized. and then allowed to cool. Water soluble
vitamins and ascorbic acid are added. the pH is adjusted to the desired range if necessary,
flavors are added, and water is added to achieve the desired total solid level. The
composition is then aseptically packaged to form an aseptically packaged nutritional
emulsion or liquid.
[0076] In the aseptic sterilization method. for example. the nutritional liquid or
emulsion is sterilized and a container is separately sterilized. The nutritional liquid may be
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sterilized utilizing a heating process, for example. The container may be sterilized by
spraying at least the interior wall of the container with hydrogen peroxide and then drying
the interior wall. Once the container and the nutritional liquid or emulsion have both been
sterilized, the liquid or emulsion is introduced into the container in a clean room
environment and the container sealed. Residual peroxide levels within the composition are
Jess than 0.5 ppm by weight of the composition.
[0077] Because aseptic sterilization generally may require the use of hydrogen
peroxide as a sterilizing agent on the interior of the container, aseptically-treated nutritional
liquids or emulsions packaged in aseptically sterilized containers can be subject to a change
in pH over time as there is generally residual hydrogen peroxide on the interior walls of the
aseptically-treated container which can enter into the liquid and emulsion and cause
changes in pH. As such, it is particularly beneficial to introduce HMB into the nutritional
liquids or emulsions as described herein to help buffer the liquid or emulsion and protect
against unwanted shifts in pH in the product over time.
[0078] Other manufacturing processes, techniques, and variations of the described
processes may be used in preparing the nutritional liquids or emulsions without departing
from the spirit and scope of the present disclosure.
Packaging
[0079] The nutritional liquids of the present disclosure are packaged into a
container, all or a majority by weight of which may be plastic, metal, glass, paper,
cardboard, a package comprising a combination of such materials such as a can with a
plastic body and a metal cap, lid, rim, or other minor packaging component.
[0080] A container may be a single-dose container, or may be a multi-dose
resealable, or recloseable container that may or may not have a sealing member, such as a
thin foil sealing member located below the cap. The container is preferably capable of
withstanding an aseptic sterilization process as described herein and known to those of
ordinary skill in the art.
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[0081] The plastic container, which in some embodiments may be an extruded
plastic container, may be comprised of a single layer of plastic, or may be comprised of two
or more (multi-layer) layers of plastic that may or may not have an intermediate layer. One
suitable plastic material is high-density polyethylene. A suitable intermediate layer is
ethylene vinyl alcohol. In one specific embodiment, the plastic container is an eight ounce
multi-layer plastic bottle with a foil seal and a recloseable cap, wherein the multilayer bottle
comprises two layers of high density polyethylene with an intermediate layer of ethylene
vinyl alcohol. In another embodiment, the plastic container is a 32 ounce single or multilayer
plastic bottle with a foil seal and a recloseable cap.
[0082] The plastic container or package used with the nutritional compositions
described herein are generally sized and configured to limit to the greatest extent possible
the amount of headspace present therein. Because oxygen located in the air in the
headspace can cause unwanted oxidation of various components ofthe nutritional
composition, it is generally preferred to limit the headspace, and hence the amount of
oxygen present in the plastic package. In one embodiment, the plastic package or container
includes Jess than about 13 cubic centimeters ofheadspace. In another embodiment, the
plastic package includes less than about 10 cubic centimeters of headspace.
[0083] Metal, glass, cardboard, and paper containers are also well-known in the
art and can be suitably selected by one of ordinary skill in the art based on the disclosure
herein. These types of containers are generally suitable for use with aseptic sterilization
methods and, as such, as suitable for use in the present disclosure.
EXAMPLES
[0084] The following examples illustrate specific embodiments and/or features of
the nutritional liquids of the present disclosure. The examples are given solely for the
purpose of illustration and are not to be construed as limitations of the present disclosure, as
many variations thereof are possible without departing from the spirit and scope of the
disclosure. All exemplified amounts are weight percentages based upon the total weight of
the composition, unless otherwise specified.
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Example I
[0085] This illustrates the buffering effect of HMB in reconstituted PediaSure®
powder (a nutritional emulsion). Known quantities of dilute hydrochloric acid are added at
room temperature to a control sample of reconstituted PediaSure® powder (Abbott
Laboratories, Columbus Ohio) (no HMB) and to a sample of reconstituted PediaSure®
powder wherein the powder is fortified with HMB at 5.17 grams per kilogram of
reconstituted powder. The HMB used to fortify the HMB-containing sample is prepared
via a cation exchange removal of calcium from calcium HMB monohydrate. Prior to the
addition of the free HMB to the samples, its pH is adjusted to 6.7 with sodium hydroxide.
An equimolar amount of sodium is added as sodium chloride to the control sample. With
continuous stirring, the pH of each sample is measured one minute after the addition of the
hydrochloric acid. From the pH reading, the hydrogen ion concentration (H+) is calculated.
The results are shown in the table below:
HCJ Added pH PediaSure IH+I pH PediaSure IH+)
(mmoi!Kg) Powder w/o nmoles/kg Powder w/ HMB nmoles/kg
HMB PediaSure PediaSure
Powder w/o Powder w/ HMB
HMB
0 6.66 218 6.71 194
0.40 6.59 256 6.65 228
0.80 6.53 294 6.60 251
1.20 6.46 346 6.54 288
1.60 6.40 397 6.48 330
2.00 6.34 456 6.43 371
2.40 6.28 523 6.38 416
2.80 6.23 587 6.32 477
3.20 6.17 674 6.27 536
3.60 6.1 I 774 6.23 587
4.00 6.06 869 6.18 659
Change -0.60 +651 -.053 +465
[0086] The data in the above table show a measurable buffering effect associated
with the presence of HMB in a nutritional liquid. The overall reduction in pH for the
sample including the HMB is less than the reduction in pH for the sample not including
HMB. Also, the [H+] increase is less in the sample including the HMB as compared to the
sample not including HMB. As such, HMB provides a buffering effect in nutritional
liquids.
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Example 2
[0087] This illustrates the buffering eftect of l-IMB in reconstituted PediaSure®
powder (a nutritional emulsion). A known quantity of hydrogen peroxide ( 1.32 mg/kg of
reconstituted powder) is added to a control sample of reconstituted PediaSure® powder (no
l-IMB) and to a sample of reconstituted PediaSure® powder wherein the powder is fortified
with l-IMB at 5.17 grams per kilogram of reconstituted powder. The l-IMB used to fortify
the sample including the l-IMB is prepared via a cation exchange removal of calcium from
calcium l-IMB monohydrate. Prior to the addition of the free HMB to the samples, its pH is
adjusted to 6. 7 with sodium hydroxide. An equimolar amount of sodium is added as
sodium chloride to the control sample. With continuous stirring. the pH of each sample is
measured after one hour at room temperature and the [H+] concentrations calculated from
the pH values. The results are shown in table below:
Time After H202 pH PediaSure IH+l, nmoles/kg, pH PediaSure IH+l, nmoles/kg,
Addition Powder w/o PediaSure Powder w/ HMB PediaSure
HMB Powder w/o Powder w/ HMB
HMB
0-Time 6.64 228 6.68 208
I Hour 6.55 281 6.61 245
Change -0.09 +53 -0.07 +37
[0088] The data in above table show a measurable buffering effect associated with
the presence of l-IMB in the nutritional emulsion. The overall reduction in pH for the
sample including the l-IMB is less than the reduction in pH for the sample not including
l-IMB. Also, the [1-1+] increase is less in the sample including the l-IMB as compared to the
sample not including l-IMB. As such. l-IMB provides a buffering effect in nutritional
liquids.
Example3
[0089] This illustrates the buffering effect of l-IMB in a ready-to-drink liquid as a
nutritional emulsion. The buffering capacity of commercially available Ensure® Plus
(Sample # 1) (Abbott Laboratories. Columbus. Ohio) and Sample #2 (liquid nutritional
emulsion based on Ensure® Plus and including 6.5 grams of calcium l-IMB per kilogram of
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emulsion and 2.38 grams of phosphate per kg of emulsion) are compared via hydrochloric
acid titration and sodium hydroxide titration. The results are shown in table below:
Acid or Base Added Sample# I (No HMB) Sample #2 (With HMB)
HCI (mmoles) required to 13.9 21.0
lower pH of 100 mL from 6.0
to 3.0
NaOH (mmolcs) required to 9.62 9.04
raise pH of I 00 m L from 7.0
to 11.0
[0090] As shown in the above table, Sample #2 including the calcium HMB is
significantly more resistant to pH decrease than is Sample # l. This data show that HMB
imparts a selective buffering effect to the nutritional liquid by resisting pH decreases (via
acid addition) more than pH increases (via NaOH addition). This characteristic is
particularly useful in nutritional emulsions and other nutritional liquids that, over time, are
more prone to pH reductions and the product instability that arises therefrom.
[0091] The pH data of Examples l, 2, and 3 shows that when HMB is present in
the nutritional liquids, it provides a buffering effect such that the nutritional liquid is more
resistant to pH decreases upon addition of acids. This discovery is particularly useful when
formulating nutritional liquids that are packaged in plastic containers. Because plastic
containers, and especially plastic containers that are aseptically treated with a hydrogen
peroxide solution, are prone to pH decreases over time, the addition of HMB into the
nutritional liquid provides not only a nutritional benefit, but also a buffering effect that
protects the nutritional liquid from the detrimental effects associated with a decrease in pH
in the nutritional liquid.
Examples: Nutritional Liquids
[0092] The following examples illustrate some ofthe shelf-stable nutritional
liquids of the present disclosure, which may be prepared in accordance with the
manufacturing methods described herein. These compositions include aqueous oil-in-water
emulsions and other nutritional liquids that are packaged in plastic and other containers and
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remain physically stable for 12-18 months after formulation/packaging at storage
temperatures ranging from 1-25°C.
[0093] The formulations are shelf stable nutritional liquids that are packaged in
plastic and other containers and are sterilized aseptic sterilization processes. The
compositions develop little or no bitter flavor or after taste over time and remain pH stable
and physically stable during a shelf life of from 12-18 months at a storage temperature
ranging from 1-25°C. The package component compositions have a residual peroxide level
of less than 0.5 ppm.
[0094] The exemplified compositions may be prepared by any known or
otherwise suitable method for preparing nutritional liquids, including the methods described
herein whereby the selected ingredients are combined into a separate carbohydrate-mineral
slurry (CHO-MIN), a separate protein-in-water slurry (PIW), and a separate protein-in-oil
slurry (PIF). For each individual slurry, the ingredients are mixed together under
temperature and shear appropriate for the selected materials, after which the different
slurries are combined in a blend tank, subjected to ultra high temperature treatment (UHT)
and then homogenized at about 3000 psi. Vitamins, flavors and other heat-sensitive
materials are then added to the homogenized mixture. The resulting mixture is diluted with
water as needed to achieve the desired concentrations and density (generally about 1.085 to
about 1.10 g/mL). The resulting nutritional liquid is then subjected to aseptic sterilization
and packaging using 240 ml recloseable plastic bottles. The packaged emulsions have a pH
of from 3.5-7.5.
Examples 4-7
[0095] Examples 4-7 illustrate nutritional emulsions of the present disclosure, the
ingredients ofwhich are listed in the table below. All ingredient amounts are listed as kg
per 1 000 kg batch of product, unless otherwise specified.
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Ingredient Example 4 Example 5 Example 6 Example 7
Water Q.S Q.S. Q.S. Q.S.
Maltodextrin DE 9-12 120.0 120.0 120.0 120.0
Sucrose 71.38 71.38 71.38 71.38
Milk Protein Concentrate 18.65 18.65 18.65 18.65
Canola Oil 27.5 27.5 27.5 27.5
Sodium Caseinate 26.68 26.68 26.68 26.68
Soy Protein Concentrate 14.05 14.05 14.05 14.05
Corn Oil 15.70 15.70 15.70 15.70
Calcium HMB monohydrate 6.00 6.5 7.0 4
Whey Protein Concentrate 3.50 3.50 3.50 3.50
Magnesium Phosphate 1.92 1.92 1.92 1.92
Potassium Citrate 6.92 6.92 6.92 6.92
Sodium Citrate 0.903 0.903 0.903 0.903
Lecithin 1.50 1.50 1.50 1.50
Sodium Tripolyphosphate 1.06 1.06 1.06 1.06
Potassium Phosphate dibasic 0.730 0.730 0.730 0.730
Potassium Chloride 1.04 1.04 1.04 1.04
Ascorbic Acid 0.235 0.235 0.235 0.235
Carrageenan 0.150 0.150 0.150 0.150
Potassium Hydroxide 0.136 0.136 0.136 0.136
TM/UTM Premix 0.1684 0.1684 0.1684 0.1684
Gellan Gum 0.050 0.050 0.050 0.050
Vitamin A,D, E Premix 0.0758 0.0758 0.0758 0.0758
Water sol. Vitamin premix 0.0728 0.0728 0.0728 0.0728
Potassium Iodide 0.00022 0.00022 0.00022 0.00022
Chromium Chloride 0.000217 0.000217 0.000217 0.000217
Flavor 3.3 3.3 3.3 3.3
Features
Soluble protein/total protein
59% 58% 57% SO%
(wt/wt)
Soluble protein/calcium HMB
6.2 5.6 5.1 7.5
(wt/wt)
Solubilized calcium (wt%) 0.045% 0.049% 0.053% 0.070%
SCBC I Solubilized calcium
5.5 5.0 4.5 3.0 (wt/wt}
Solubilized citrate/solubilized c
3.5 3.0 2.5 1.5
alciutn (equiv)
Examples 8-11
[0090] These examples illustrate nutritional emulsions of the present disclosure,
the ingredients of which are listed in the table below. All ingredient amounts are listed as
kg per 1 000 kg batch of product, unless otherwise specified.
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Table 2: Nutritional Emulsions
Ingredient Example 8 Example 9 Example 10 Example 11
Water Q.S Q.S. Q.S. Q.S.
Maltodextrin DE 9-12 120.0 120.0 120.0 120.0
Sucrose 71.38 71.38 71.38 71.38
Milk Protein Concentrate 14.65 13.65 12.65 11.65
Canota Oil 27.5 27.5 27.5 27.5
Sodium Caseinate 30.68 31.68 32.68 33.68
Soy Protein Concentrate 14.05 14.05 14.05 14.05
Corn Oil 15.70 15.70 15.70 15.70
Calcium HMB monohydrate 6.00 6.5 7.0 7.5
Whey Protein Concentrate 3.50 3.50 3.50 3.50
Magnesium Phosphate 1.92 1.92 1.92 1.92
Potassium Citrate 6.92 6.92 6.92 6.92
Sodium Citrate 0.903 0.903 0.903 0.903
Lecithin 1.50 1.50 1.50 1.50
Sodium Tripolyphosphate 1.06 1.06 1.06 1.06
Potassium Phosphate dibasic 0.730 0.730 0.730 0.730
Potassium Chloride 1.04 1.04 1.04 1.04
Ascorbic Acid 0.235 0.235 0.235 0.235
Carrageenan 0.150 0.150 0.150 0.150
Potassium Hydroxide 0.136 0.136 0.136 0.136
TMIUTM Premix 0.1684 0.1684 0.1684 0.1684
Gellan Gum 0.050 0.050 0.050 0.050
Vitamin A,D, E Premix 0.0758 0.0758 0.0758 0.0758
Water sol. Vitamin premix 0.0728 0.0728 0.0728 0.0728
Potassium Iodide 0.00022 0.00022 0.00022 0.00022
Chromium Chloride 0.000217 0.000217 0.000217 0.000217
Flavor 3.3 3.3 3.3 3.3
Features
Soluble protein/total protein
(wt/wt) 63% 64% 65% 66%
Soluble protein/calcium HMB
(wt/wt) 6.6 6.2 5.8 5.0
Solubilized calcium (wt%) 0.045% 0.049% 0.053% 0.070%
SCBC I Solubilized calcium
5.5 5.0 4.5 3.0 (wt/wt)
Solubilized citrate/solubilized
3.5 3.0 2.5 1.5 calcium (equiv)
Examples 12-15
[0091] These examples illustrate nutritional emulsions of the present disclosure,
the ingredients of which are listed in the tollowing table below. All ingredient amounts are
listed as kilogram per 1 000 kilogram batch of product, unless otherwise specified.
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Ingredient Example 12 Example 13 Example 14 Example IS
Water Q.S Q.S. Q.S. Q.S.
Maltodextrin DE 9-12 120.0 120.0 120.0 120.0
Sucrose 71.38 71.38 71.38 71.38
Milk Protein Concentrate 0.00 0.00 8.65 10.65
Canota Oil 27.5 27.5 27.5 27.5
Sodium Caseinate 45.33 45.33 36.68 34.68
Soy Protein Concentrate 0.00 0.00 12.05 9.05
Corn Oil 15.70 15.70 15.70 15.70
Calcium HMB monohydrate 6.0 6.5 7.0 8.0
Whey Protein Concentrate 17.55 17.55 5.50 8.50
Magnesium Phosphate 1.92 1.92 1.92 1.92
Potassium Citrate 6.92 6.92 6.92 6.92
Sodium Citrate 0.903 0.903 0.903 0.903
Lecithin 1.50 1.50 1.50 1.50
Sodium Tripolyphosphate 1.06 1.06 1.06 1.06
Potassium Phosphate dibasic 0.730 0.730 0.730 0.730
Potassium Chloride 1.04 1.04 1.04 1.04
Ascorbic Acid 0.235 0.235 0.235 0.235
Carrageenan 0.150 0.150 0.150 0.150
Potassium Hydroxide 0.136 0.136 0.136 0.136
TM/UTM Premix 0.1684 0.1684 0.1684 0.1684
Gellan Gum 0.050 0.050 0.050 0.050
Vitamin A,D, E Premix 0.0758 0.0758 0.0758 0.0758
Water sol. Vitamin premix 0.0728 0.0728 0.0728 0.0728
Potassium Iodide 0.00022 0.00022 0.00022 0.00022
Chromium Chloride 0.000217 0.000217 0.000217 0.000217
Flavor 3.3 3.3 3.3 3.3
Features
Soluble protein/total protein
94% 93% 71% 73%
(wt/wt)
Soluble protein/calcium HMB
9.8 9.0 6.4 5.1
(wt/wt)
Solubilized calcium (wt%) 0.045% 0.050% 0.058% 0.070%
SCBC I Solubilized calcium
10 8.8 (wt/wt) 5.9 3.8
Solubilized citrate/solubilized
3.8 3.4 2.9 1.5 calcium (equiv)
Examples 16-19
[0092] These examples illustrate nutritional emulsions of the present disclosure,
the ingredients of which are listed in the following table below. All ingredient amounts are
listed as kilogram per 1 000 kilogram batch of product, unless otherwise specified.
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Table 4: Nutritional Emulsions
Ingredient Example 16 Example 17 Exam_Qle 18 Example 19
Water Q.S Q.S. Q.S. Q.S.
Sucrose 96.05 96.05 96.05 96.05
Maltodextrin DE 5 16.46 16.46 16.46 16.46
Milk Protein Concentrate 18.95 0.00 8.95 25.00
Soy Oil I 3.31 13.31 13.3 I 13.31
Fructooligosaccharides 8.69 8.69 8.69 8.69
Soy Protein Concentrate 13.80 0.00 10.80 5.92
Canola Oil 5.32 5.32 5.32 5.32
Sodium Caseinate 25.64 58.39 61.39 28.00
Corn Oil 11.70 11.70 11.70 11.70
Calcium HMB monohydrate 6.70 7.00 2.50 5.00
Dietary Fiber 4.51 4.51 4.51 4.51
Whey Protein Concentrate 3.44 3.44 13.44 2.92
Potassium Citrate 4.48 4.48 4.48 4.48
Flavor 2.00 2.00 2.00 2.00
Magnesium Phosphate 2.75 2.75 2.75 2.75
Lecithin 1.50 1.50 1.50 1.50
Di sodium Phosphate Dihyd 0.436 0.436 0.436 0.436
Potassium Phosphate Dibasic 0.556 0.556 0.556 0.556
Sodium Chloride 0.498 0.498 0.498 0.498
Choline Chloride 0.480 0.480 0.480 0.480
Ascorbic Acid 0.465 0.465 0.465 0.465
Carrageenan 0.300 0.300 0.300 0.300
Trace/Ultra Trace minemls 0.420 0.420 0.420 0.420
Potassium Chloride 0.698 0.698 0.698 0.698
Potassium Hydroxide 0.321 0.321 0.321 0.321
L-carnitine 0.180 0.180 0.180 0.180
Water soluble Vitamin Premix 0.07269 0.07269 0.07269 0.07269
Vitamin DEK premix 0.128 0.128 0.128 0.128
Gellan Gum 0.050 0.050 0.050 0.050
Vitamin A Palmitate 0.008245 0.008245 0.008245 0.008245
Vitamin D3 0.000399 0.000399 0.000399 0.000399
Potassium Iodide 0.000194 0.000194 0.000194 0.000194
Features
Soluble protein/total protein
58% 95% 80% (wt/wt) 61%
Soluble protein/calcium HMB
5.4 8.4 30 (wt/wt)
Solubilized calcium (wt%) 0.050% 0.060% 0.080% 0.055%
SCBC I Solubilized calcium
4.4 9.7 8.8 4.9 (wt/wt)
Solubilized citrate/solubilized
calcium (equiv) 1.3 3.1 2.7 2.9
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Examples 20-23
[0093] These examples illustrate nutritional emulsions of the present disclosure,
the ingredients ofwhich are listed in the following table below. All ingredient amounts are
listed as kilogram per I 000 kilogram batch of product, unless otherwise specified.
Ingredient Example 20 Example 21 Example 22 Example 23
Water Q.S Q.S. Q.S. Q.S.
Sucrose 96.05 96.05 96.05 96.05
Maltodextrin DE 5 16.46 16.46 16.46 16.46
Milk Protein Concentrate 24.98 0.00 25.00 10.00
Soy Oil 13.31 13.31 13.31 13.31
Fructooligosaccharides 8.69 8.69 8.69 8.69
Soy Protein Concentrate 13.64 0.00 5.87 10.64
Canota Oil 5.32 5.32 5.32 5.32
Sodium Caseinate 25.64 58.39 61.39 28.00
Com Oil 11.70 11.70 11.70 11.70
Calcium HMB monohydrate 6.50 3.5 4.25 7.5
Dietary Fiber 4.51 4.51 4.51 4.51
Whey Protein Concentrate 3.40 17.04 6.87 6.40
Potassium Citrate 4.48 4.48 4.48 4.48
Flavor 2.00 2.00 2.00 2.00
Magnesium Phosphate 2.75 2.75 2.75 2.75
Lecithin 1.50 1.50 1.50 1.50
Di sodium Phosphate Dihyd 0.436 0.436 0.436 0.436
Potassium Phosphate Dibasic 0.556 0.556 0.556 0.556
Sodium Chloride 0.498 0.498 0.498 0.498
Choline Chloride 0.480 0.480 0.480 0.480
Ascorbic Acid 0.465 0.465 0.465 0.465
Carrageenan 0.300 0.300 0.300 0.300
Trace/Ultra Trace minerals 0.420 0.420 0.420 0.420
Potassium Chloride 0.698 0.698 0.698 0.698
Potassium Hydroxide 0.321 0.321 0.321 0.321
L-camitine 0.180 0.180 0.180 0.180
Water soluble Vitamin Premix 0.07269 0.07269 0.07269 0.07269
Vitamin DEK premix 0.128 0.128 0.128 0.128
Gellan Gum 0.050 0.050 0.050 0.050
Vitamin A Palmitate 0.008245 0.008245 0.008245 0.008245
Vitamin D3 0.000399 0.000399 0.000399 0.000399
Potassium Iodide 0.000194 0.000194 0.000194 0.000194
Features
Soluble protein/total protein (wt/wt) 56% 94% 74% 68%
Soluble protein/calcium HMB
(wt/wt) 5.8 20 17 5.0
Solubilized calcium (wt'Yo) 0.057% 0.085% 0.079% 0.060%
SCBC I Solubilized calcium (wt/wt) 2.9 7.9 6.8 4.7
Solubilized citrate/solubilized
3.0 0.9 1.5 2.2 calcium (equiv)
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Examples 24-27
[0094] These examples illustrate clear, non-emulsion, liquids of the present
disclosure, the ingredients of which are listed in the following table below. All ingredient
amounts are listed as kilogram per I 000 kilogram batch of product, unless otherwise
specified. The liquids have an adjusted pH of between 4.5 and 7.2.
Ingredient Example 24 Example 25 Example 26 Example 27
Ingredient Water Q.S. Q.S. o.s. Q.S.
Sucrose 27.5 27.5 27.5 27.5
Calcium HMB monohydrate 3.00 5.00 9.69 18.00
L-Lysine Monohydrochloride 2.26 2.26 2.26 2.26
Flavor 1.80 1.80 1.80 1.80
Citric Acid 1.03 1.03 1.03 1.03
Ascorbic Acid 0.504 0.504 0.504 0.504
Malic Acid 0.342 0.342 0.342 0.342
Liquid Sucralose (25%) 0.194 0.194 0.194 0.194
Acesulfame Potassium 0.113 0.113 0.113 0.113
Vitamin 03 Water dispersible 0.0242 0.0242 0.0242 0.0242
Colorant 0.0012 0.0012 0.0012 0.0012
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WHAT IS CLAIMED IS:
1. A packaged composition comprising a peroxide-treated aseptic package and a
nutritional liquid hermetically sealed therein, the nutritional liquid comprising betahydroxy-
beta-methylbutyrate and at least one of fat, carbohydrate, and protein.
2. The packaged composition of claim I wherein a majority by weight of the
peroxide-treated aseptic package is plastic.
3. The composition of claim 1 wherein a majority by weight of the peroxide-treated
aseptic package is metal.
4. The packaged composition of claim l wherein the nutritional liquid comprises
from about 0.2% to about 5.0% beta-hydroxy-beta-methylbutyrate by weight of the
nutritional liquid.
5. The composition of claim I wherein the nutritional liquid comprises fat,
carbohydrate, protein. and beta-hydroxy-beta-methylbutyrate, wherein the protein
comprises from 50% to I 00% by weight of soluble protein and includes
phosphoserine-containing protein having at least about 1 00 mmoles of phosphoserine
per kilogram of phosphoserine-containing protein.
6. The composition of claim 5 wherein the soluble protein is selected from sodium
caseinate, whey protein concentrate. or combinations thereof.
7. The composition of claim 1 wherein the nutritional liquid has a weight ratio of a
soluble calcium binding capacity to total soluble calcium of from about 2.3: I to about
12:1.
8. The composition of claim I wherein the peroxide-treated aseptic package contains
at least about 13 cubic centimeters of heads pace.
9. A method of preparing a pH-stable nutritional liquid in a peroxide-treated aseptic
package, the method comprising:
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wo 2011/094548 PCT/US2011/022932
combining a fat, protein, carbohydrate and beta-hydroxy-beta-methylbutyrate
together to form a nutritional liquid;
sterilizing the nutritional liquid;
sterilizing aseptically a package by treating the interior of the package with a
peroxide-containing solution; and
introducing the sterilized nutritional liquid into the aseptically sterilized
package.
I 0. The method of claim 9 wherein the peroxide-treated aseptic package comprises a
material selected from the group consisting of glass. plastic, metal, paper, cardboard,
and combinations thereof.
II. The method of claim 9 wherein the peroxide-treated aseptic package is
reclosable.
12. The method of claim 9 wherein the protein includes a soluble protein selected
from the group consisting of sodium caseinate, whey protein concentrate, and
combinations thereof.
13. The method of claim 9 wherein the nutritional composition has a weight ratio of a
soluble calcium binding capacity to total soluble calcium offrom about2.3:1 to about
12:1.
14. The method of claim 9 wherein the nutritional liquid comprises a weight ratio of
a soluble calcium binding capacity to total soluble calcium of from about 5: I to about
12:1.
15. The method of claim 9 wherein the peroxide-containing solution is hydrogen
peroxide.