PLASTIC PACKAGED NUTRITONAL LIQUIDS
COMPRISING HMB
FIELD OF THE DISCLOSURE
[0001 ] The present disclosure relates to plastic 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] There are many different types of containers and container materials that
are suitable for processing and packaging nutritional liquids such as shelf-stable nutritional
emulsions and other liquids. Such containers are designed to accommodate elevated
processing temperatures associated with many different types of sterilization processes.
These containers include glass, aluminum or other metals, paper, plastic or other polymer
materials, various laminates, and combinations thereof, many of which further comprise
other container materials to provide for the safe and effective packaging of the nutritional
liquid over the desired shelf life. Among these many choices, plastic containers have
become increasingly popular among consumers and manufacturers as a convenient, cost
effective, and light weight container for many different types of nutritional liquids.
[0005] Although plastic containers are commercially advantageous and have
been used in the past for the packaging of nutritional liquids, including nutritional
emulsions prepared by either retort or aseptic processing methods, plastic packaging has
traditionally suffered from a number of shortcomings such that its use has been generally
limited. For example, nutritional liquids in plastic packages are subject to a more
pronounced drop in pH over lime as compared to nutritional liquids packaged in metal,
glass or similar other materials. This reduction in pH of the product over time in plastic
containers may be attributed to at least three oxidation-enhancing factors, all of which can
increase the oxidation of the nutritional liquids contained in the plastic container and result
in a reduction in pH over time.
[0006] First, plastic containers are often subjected to more severe heat treatment
during retort sterilization as compared to metal containers since plastic is less conductive
of heat than metal and so increased temperatures are required with plastic to achieve the
intended sterilization result. This more severe heat treatment can result in increased
oxidation of the nutritional liquid contained inside the container, especially when the
nutritional product contains fat or other easily oxidized ingredients.
[0007] Second, plastic containers often contain a larger headspace volume as
compared to many metal containers, which means there is a larger volume of air or gas
present in plastic containers as compared to metal containers. Generally, a plastic
container will often have about two to three times the headspace volume as compared to an
equally-sized metal container. This increased volume of headspace air or gas can lead to
increased oxidation of the nutritional liquid within the container.
[0008] Third, plastic containers have increased permeability to environmental air
as compared to metal containers. Because air can more easily permeate plastic and enter
the nutritional composition matrix, an increase in oxidation can occur in the nutritional
composition.
[0009] The reduction in pH of the nutritional liquid over time due to oxidation as
described above can have numerous detrimental effects on the nutritional liquid inside the
package including: (1) 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.
[0010] There is therefore a need for stable nutritional liquids, such as stable
protein or milk-based liquids or emulsions, that can be retort or aseptically sterilized and
packaged in plastic containers or packages and that are stable and resistant to a reduction
in pH over time.
SUMMARY OF THE DISCLOSURE
[001 1] The present disclosure is directed to packaged nutritional compositions
comprising a plastic package and a nutritional liquid contained therein, the nutritional
liquid comprising beta-hydroxy-beta-methylbutyrate and at least one of fat, protein, and
carbohydrate.
[00 ] The present disclosure is further directed to packaged nutritional
compositions comprising a plastic package and a nutritional emulsion contained therein,
the nutritional emulsion being an oil-in-water emulsion comprising beta-hydroxy-betamethylbutyrate
and fat.
[001 ] The present disclosure is further directed to packaged nutritional
compositions comprising a plastic package and a retort-sterilized nutritional composition
contained therein, the nutritional liquid comprising at least about 4.5 grams of betahydroxy-
beta-methylbutyrate per kilogram of the nutritional liquid, and further comprising
fat, protein, and carbohydrate, wherein the protein comprise from about 35% to 100% by
weight of soluble protein as defined herein.
[0014] The present disclosure is further directed to packaged nutritional
compositions comprising a plastic package and an aseptically-sterilized nutritional liquid
contained therein, the nutritional liquid comprising fat, protein, carbohydrate, and at least
about 4.5 grams of beta-hydroxy-beta-methylbutyrate per kilogram of the nutritional liquid
composition, wherein the protein comprises from about 35% to 100% soluble protein by
weight of the total protein in the liquid composition.
[0015] The present disclosure is further directed to a method of preparing a pHstable
nutritional liquid in a plastic package, the method comprising combining a fat,
protein, carbohydrate and beta-hydroxy-beta-methylbutyrate together to form a nutritional
liquid, introducing the nutritional liquid into a plastic package, and retort sterilizing the
resulting plastic packaged nutritional liquid.
[0016] The present disclosure is further directed to a method of preparing a pHstable
nutritional liquid in a plastic package, the method comprising combining a fat,
protein, carbohydrate and beta-hydroxy-beta-methylbutyrate together to form a nutritional
liquid, sterilizing the nutritional liquid, sterilizing a plastic package, and introducing the
sterilized nutritional liquid into the sterilized plastic package.
[00 17] It has been discovered that the addition of beta-hydroxy-betamethylbutyrate
(HMB) into nutritional liquids, such as nutritional emulsions, imparts an
unexpected buffering effect to the nutritional liquid such that the nutritional liquid is more
resistant to pH decreases upon a shift in hydrogen ion concentration over time. 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 then be packaged in plastic containers where the
resulting nutritional liquid is more pH-stable due to the buffering effect of the HMB
present in the liquid. Because plastic packages are inherently subject to a shift 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 retort sterilized in
plastic packages or aseptically sterilized and packaged in plastic packages.
DETAILED DESCRIPTION OF THE DISCLOSURE
[00 18] The packaged nutritional compositions of the present disclosure comprise
a plastic container and a nutritional liquid comprising HMB contained therein, and may
also include other elements, features, or ingredients. The essential elements, features or
ingredients of the nutritional liquids, as well as some of the many optional variations and
additions, are described in detail hereafter.
[0019] The term "HMB" as used herein, unless otherwise specified, refers to
beta-hydroxy-beta-methylbutyrate (also referred to as beta-hydroxy 1-3-methyl butyric acid,
beta-hydroxy 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 al weights, percentages, and concentrations as used herein and
directed to calcium HMB are based on the weight of calcium HMB monohydrate, unless
otherwise specified.
[0020] 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 1°C 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 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-II+) 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
values represent the ratio of shear stress to shear rate, expressed as dynes-second/cm 2, or
poise, or more typically as centipotse (cps) or one hundredth of a poise.
[0021] 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 for 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.
[0022] The term "nutritional emulsion" as used herein, unless otherwise
specified, means nutritional liquids formulated as aqueous emulsions, including water-inoil,
oil-in-water, and complex emulsions, but most typically oil-in-water emulsions.
[0023] 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.
[0024] 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-methylbutyrate.
[0025] 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.
[0026] 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.
[0027] 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 by¬
products that may be included in commercially available materials, unless otherwise
specified.
[0028] 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.
[0029] 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.
[0030] The various embodiments of the nutritional compositions of the present
disclosure may also be substantially free of any optional or selected essential ingredient or
feature described herein, provided that the remaining nutritional compositions still contain
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 composition
contains less than a functional amount of the optional ingredient, typically less than about
0.5% by weight, including less than about 0.1%, and also including zero percent, by
weight of such optional or selected essential ingredient.
[003 1] The nutritional liquids and corresponding manufacturing methods of the
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
[0032] 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
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.
[0033] The nutritional liquids may also be characterized as ready-to-feed or
ready-to-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.
[0034] 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 liquids may also be
formulated as non-shelf stable products requiring refrigeration to maintain an extended
shelf life.
[0035] 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 of the
nutritional liquids.
[0036] 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 .085 g/ml to about 1.10 g/ml.
[0037] 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 ml. These
nutritional compositions also comprise HMB as described herein, the amount of which
most typically ranges from about 0.5 to about 3.0 g/240 ml. including from about 0.75 to
about 2.0 g/240 ml. including about 1.5 g/240 ml.
[0038] 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.
[0039] Although the serving size for the nutritional liquids can vary depending
upon a number of variables, a typical serving size ranges from about 100 to about 300 ml,
including from about 150 to about 250ml, including from about 190 ml to about 240 ml.
Bcta-Hvdroxy-Bcta-Methylbutv rate (HMB)
[0040] 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.
[0041] The nutritional liquids most suitably comprise a calcium salt of HMB,
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 of HMB 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.
[0042] The concentration of 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 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
[0043] 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.
[0044] 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 any other fat, protein, and or carbohydrate ingredients as described
herein.
[0045] Carbohydrate concentrations most typically range from about 5% to about
40%, including from about 7% to about 30%, including from about 10% to about 25%, by
weight of the nutritional emulsion; fat concentrations most typically range from about 1%
to about 30%. including from about 2% to about 15%, and also including from about 4%
to about 10%, by weight of the nutritional emulsion; and protein concentrations most
typically range from about 0.5% to about 30%, including from about 1% to about 15%,
and also including from about 2% to about 10%, by weight of the nutritional liquids.
[0046] 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 of total calories in the nutritional compositions as set forth in the following
table.
[0047] 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.
[0048] 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, ricederived
carbohydrates, glucose, fructose, lactose, high fructose corn syrup, honey, sugar
alcohols (e.g., maltitol, erythritol, sorbitol), and combinations thereof.
[0049] 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, corn), 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.
[0050] 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 of HMB or other buffering system herein, may result in a decrease in the
composition pH and consequently a reduction in product stability.
Soluble Protein
[005 1] 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.
[0052] 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 of the nutritional liquid.
[0053] 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 1.0. and also including from about 8.0 to about 10.0.
[0054] 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 determine 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.
[0055] 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.
[0056] 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
400 mmoles, including from about 200 to about 350 mmoles, and also including from
about 250 to about 350 mmoles, of phosphoserine per kilogram of protein.
[0057] 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 H B may be at least about 3:1, including at least about 5:1, and
also including at least about 7:1, and also including from about 9:1 to about 30:1. 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.
[0058] 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 .7.
[0059] 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 phosphoserine used in calculating the ratios are not bound, complexed,
or otherwise attached to a polyvalent cation such as calcium or magnesium.
[0060] 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.
[0061] 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 phosphoserine 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 sodium caseinate and additionally any protein from the calcium caseinate fraction that
is not bound to calcium.
Soluble Calcium Binding Capacity
[0062] 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.
[0063] 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 / [soluble calcium]
SCBC = (0.32 x [soluble citrate] + 0.63 [soluble phosphate] + 0.013 x [soluble protein])
[0064] 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
[0065] 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.
[0066] The concentration of calcium in the nutritional liquids may exceed about
10 mg/L, and may also include concentrations of from about 25 mg/L to about 3000 mg/L,
also including from about 50 mg/L to about 500 mg/L, and also including from about 100
mg/L to about 300 mg/L.
[0067] 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 700 mg/L, also
including from about 500 mg/L to about 700 mg/L, and also including from about 400
mg/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.
[0068] 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.
[0069] 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
[0070] 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 D2 (ergocalciferol) and Vitamin D3 (cholecalciferol) or other forms
suitable for use in a nutritional product.
[007 1] The amount of Vitamin D in the nutritional liquid most typically ranges
up to about 1000 1U, more typically from about 0 to about 600 IU. and more typically
from about 50 to 400 IU per serving.
Optional Ingredients
[0072] 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 pharmaceutical 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.
[0073] 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.
[0074] 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 B12, carotenoids, niacin, folic acid, pantothenic acid,
biotin, vitamin C, choline, inositol, salts, and derivatives thereof, and combinations
thereof.
[0075] 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.
[0076] 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, gellan gum, and combinations thereof. The amount of masking agents
in the nutritional liquids 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 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.
Plastic Package
[0077] The nutritional liquids of the present disclosure are contained within a
plastic package suitable for use with nutritional products or food. The plastic package
should be made from food grade plastics approved by the U.S. Food and Drug
Administration or other suitable regulatory group.
[0078] The packaged nutritional liquids are sterile formulations, which mean the
packaged liquids have been treated or otherwise processed to reduce the amount or
concentration of transmissible agents such as fungi, bacteria, viruses, spore forms, and so
forth, to the extent necessary to render such packaged liquids suitable for oral consumption
by humans. Sterilization processes may include various techniques involving the
application of heat, chemicals, irradiation, high pressure, filtration, or combinations or
variations thereof.
[0079] The plastic packaged liquids are closed systems comprising a removeable
closure positioned over an opening within the package through which the liquid can be
extracted prior to or during consumption during shelf-life. These plastic packages may be
single or multi dose containers and may or may not have a sealing member, such as a thin
foil sealing member located over the opening. The plastic container may be capable of
withstanding sterilization processing, including aseptic sterilization processes, retort
sterilization processes, or both processes. The plastic package may have a reclosable cap.
[0080] The plastic container, which in some embodiments may be an extruded
plastic container, may comprise a single layer of plastic, or may comprise a plurality of
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 multi-layer
plastic bottle with a foil seal and a recloseable cap.
[0081] The plastic container or package used with the nutritional liquids
described herein is generally sized and configured to minimize the headspace volume
present therein. Because oxygen from air in the headspace can cause unwanted oxidation
of various components of the nutritional liquid, it is generally preferred to limit the
headspace volume and hence the amount of oxygen present in the plastic package. In one
embodiment, the plastic package or container includes less than about 1 cubic centimeters
of headspace. In another embodiment, the plastic package includes less than about 0
cubic centimeters of headspace.
Method of Use
[0082] The nutritional liquids described herein are useful to provide supplement,
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 100 to about 300 ml, including from about 150 to about 250
ml, including from about 1 0 ml to about 240 ml, 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 H B per serving.
[0083] 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 1 to about 6 months, including from about 1 to about 3 months, one or
more of ) 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, and 4) to
help with muscle recovery following exercise or other trauma, and 5) to reduce muscle
protein breakdown following exercise.
[0084] Such methods are also helpful to achieve one or more of 1) 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.
Methods of Manufacture
[0085] The nutritional liquids may be manufactured by any known or otherwise
suitable method for making nutritional emulsions or other nutritional liquids, most
typically for making nutritional aqueous emulsions or milk based emulsions.
[0086] In one suitable manufacturing process, for example, at least three separate
slurries are prepared, including a protein-in-fat (PIF) slurry, a carbohydrate-mineral (CHOMIN)
slurry, and a protein-in-water (PIW) slurry. The PIF slurry is formed by heating and
mixing the selected oils (e.g., canola oil, corn 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. Avicel, gellan, carrageenan), and calcium HMB or
other HMB source. The resulting CHO-MIN slurry is held for 10 minutes with continued
heat and agitation before adding additional minerals (e.g., potassium chloride, magnesium
carbonate, potassium iodide, etc.) and/or carbohydrates (e.g., frucotooligosaccharide,
sucrose, corn 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.
[0087] 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 the composition is added to retort stable containers and then subjected to
retort sterilization to form retort sterilized nutritional emulsions or liquids.
[0088] In a retort sterilization method, for example, the nutritional liquid or
emulsion may be preheated and then filled into a clean container, hermetically sealed, and
placed in a steam chamber and sterilized, normally at about 121°C for about 5 to about 45
minutes. The batch is then cooled and the retort filled with a new batch. Because
sterilization takes place after filling, the need for aseptic handling is eliminated, although
heat resistant plastic (or another heat resistant material) must be used due to the high
temperatures involved. In one specific retort sterilization embodiment, a hydrostatic tower
method is utilized and includes conveying slowly the sealed containers through successive
heating and cooling zones in a sterilizer. The zones are dimensioned to correspond to the
required temperatures and holding times in the various treatment stages.
[0089] In an aseptic sterilization method, the nutritional liquid or emulsion may
be sterilized and a container is separately sterilized. The nutritional liquid may be
sterilized utilizing a heating process, for example. The container may be sterilized by
spraying the interior wall of the container with hydrogen peroxide and then drying the
interior wall. Once the container and the nutritional liquid have both been sterilized, the
nutritional liquid is introduced into the container in a clean room environment and the
container sealed.
[0090] 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.
[00 1] 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.
EXAMPLES
[0092] 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.
Example 1
[0093] 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:
HC Added pH PediaSurc |H+| pH PediaSure [H+l
(mmol/Kg) Powder w/o nmolcs/kg Powder w/ nmoles/kg
HMB PediaSure HMB 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 1 774 6.23 587
4.00 6.06 869 6.18 659
Change -0.60 +651 -.053 +465
[0094] 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.
Example 2
[0095] This illustrates the buffering effect of HMB in reconstituted PediaSure®
powder (a nutritional emulsion). A known quantity of hydrogen peroxide ( .32 mg/kg of
reconstituted powder) is added to a control sample of reconstituted PediaSure® powder
(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 sample including the HMB 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 after one hour at room temperature and the [H+]
concentrations calculated from the pH values. The results are shown in table below:
Time After pH PediaSure [H+], pH PediaSure IH+],
H 0 Addition Powder w/o nmoles/kg, Powder w/ nmolcs/kg,
HMB PediaSure HMB PediaSure
Powder w/o Powder w/
HMB HMB
0-Time 6.64 228 6.68 208
Hour 6.55 281 6.61 245
Change -0.09 +53 -0.07 +37
[0096] The data in the above table show a measurable buffering effect associated
with the presence of HMB in the nutritional emulsion. 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.
Example 3
[0097] This illustrates the buffering effect of HMB 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 HMB per kilogram
of emulsion and 2.380 grams (g) of phosphate per kg of emulsion) are compared via
hydrochloric acid titration and sodium hydroxide titration. The results are shown in table
below:
[0098] As shown in the above table. Sample #2 including the calcium HMB is
significantly more resistant to pH decrease than is Sample # 1. 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.
[0099] The pH data of Examples 1, 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; Liquid Nutritionals
[00100] The following examples illustrate some of the self-stable nutritional
liquids of the present disclosure, which may be prepared in accordance with the
manufacturing methods described herein, such that each exemplified composition, unless
others specified, includes an aseptically processed embodiment and a retort packaged
embodiment. The formulations are shelf stable nutritional liquids that are packaged in
plastic containers and sterilized by either retort or 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 storage temperatures
ranging from 1-25°C.
[0101] 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-fat 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 or retort sterilization and packaging using
240 m recloseable plastic bottles. The packaged emulsions have a pH of from 3.5-7.5.
Examples 4-7
[01 02] Examples 4-7 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 1000 kg batch of product, unless otherwise specified.
Table 1: Nutritional Emulsions
Examples 8-11
[01 03] 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 1000 kg batch of product, unless otherwise specified.
Tabic 2: Nutritional Emulsions
Examples 12-15
[0104] 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 1000 kilogram batch of product, unless otherwise specified.
Table 3: Nutritional Emulsions
Examples 16-19
[0105] 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 1000 kilogram batch of product, unless otherwise specified.
Table 4: Nutritional Emulsions
Examples 20-23
[0 06] 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 1000 kilogram batch of product, unless otherwise specified.
Table 5 : Nutritional Emulsions
Examples 24-27
[0107] 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 000 kilogram batch of product, unless otherwise
specified. The liquids have an adjusted pH of between 4.5 and 7.2.
Table 6: Nutritional Emulsions

WHAT IS CLAIMED IS:
1. A composition comprising a plastic package and a nutritional liquid contained
therein, the nutritional liquid comprising beta-hydroxy-beta-methylbutyrate and at
least one of fat, protein, and carbohydrate.
2. The composition of claim 1 wherein the nutritional liquid is retort sterilized.
3. The composition of claim 1 wherein the nutritional liquid is aseptically packaged.
4. The composition of claim 1 wherein the nutritional liquid comprises from about
0.1% to about 8% beta-hydroxy-beta-methylbutyrate by weight of the nutritional
liquid.
5. The composition of claim 1 wherein the nutritional liquid comprises fat,
carbohydrate, protein, and beta-hydroxy-beta-methylbutyrate, wherein the protein
comprises from about 35% to 100% by weight of soluble protein and includes
phosphoserine-containing protein having at least about 100 mmoles of phosphoserine
per kilogram of phosphoserine-containing protein.
6. The composition of claim 5 wherein the soluble protein is selected from the group
consisting of sodium caseinate, whey protein concentrate, and combinations thereof.
7. The composition of claim 5 wherein the nutritional liquid comprises a weight ratio
of soluble protein to beta-hydroxy-beta-methylbutyrate of from about 5:1 to about
12:1.
8. 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 to about
20.0.
9. The composition of claim 1 wherein the plastic package contains at least about 13
cubic centimeters of headspace.
10. A composition comprising a plastic package and a retort-sterilized nutritional
liquid contained therein, the nutritional liquid comprising at least about 4.5 grams of
beta-hydroxy-beta-methylbutyrate per kilogram nutritional liquid, fat, protein, and
carbohydrate, wherein the protein is comprised of from about 35% to 100 soluble
protein.
1. The composition of claim 10 wherein the soluble protein includes phosphoserinecontaining
protein having at least about 100 mmoles of phosphoserine per kilogram of
phosphoserine-containing protein.
12. The composition of claim 0 wherein the plastic package is reclosable.
13. The composition of claim 10 wherein the soluble protein comprises at least one
protein selected from the group consisting of sodium caseinate, whey protein
concentrate, and combinations thereof.
14. The composition of claim 10 wherein the nutritional liquid comprises a weight
ratio of soluble protein to beta-hydroxy-beta-methylbutyrate of from about 5 :1 to
about 12:1.
15. The composition of claim 10 wherein the plastic package contains at least about
3 cubic centimeters of headspace.
16. A composition comprising a plastic package and an aseptically-sterilized
nutritional liquid contained therein, the nutritional liquid comprising at least about 4.5
grams of beta-hydroxy-beta-methylbutyrate per kilogram nutritional liquid, fat,
protein, and carbohydrate, wherein the protein is comprised of from about 35% to 100
soluble protein.
17. The composition of claim 6 wherein the soluble protein includes phosphoserinecontaining
protein having at least about 100 mmoles of phosphoserine per kilogram of
phosphoserine-containing protein.
18. The composition of claim 16 wherein the plastic package is reclosable.
19. The composition of claim 16 wherein the soluble protein is selected from the
group consisting of sodium caseinate, whey protein concentrate, and combinations
thereof.
20. The composition of claim 16 wherein the nutritional liquid comprises a weight
ratio of soluble protein to calcium beta-hydroxy-beta-methylbutyrate of from about
5 :1 to about 12:1 .
2 . A method of preparing a pH-stable nutritional liquid in a plastic package, the
method comprising:
combining a fat, protein, carbohydrate and beta-hydroxy-beta-methylbutyrate
together to form a nutritional liquid;
introducing the nutritional liquid into a plastic package; and
retort sterilizing the nutritional liquid in the plastic package.
22. A method of preparing a pH-stable nutritional liquid in a plastic package, the
method comprising:
combining a fat, protein, carbohydrate and beta-hydroxy-beta-methylbutyrate
together to form a nutritional liquid
sterilizing the nutritional liquid;
sterilizing a plastic package; and
introducing the sterilized nutritional liquid into the sterilized plastic package.