Abstract: Disclosed are stabilized nutritional compositions having a stabilizer system including starch or a combination of starch and maltotriose and methods for manufacturing the compositions. The retrogradation effect commonly seen with starch stabilizers is substantially reduced or even eliminated in the disclosed nutritional compositions.
STABILIZED NUTRITIONAL COMPOSITIONS INCLUDING STARCH
CROSS REFERENCE TO RELATED APPLICATIONS
The present application hereby claims the benefit of the provisional patent
application Serial No. 61/581,640, filed on December 30, 201 1, the disclosure of
which is hereby incorporated by reference in its entirety. The present application also
claims the benefit of the provisional patent application Serial No. 61/581,642, filed
December 30, 201 1, the disclosure of which is hereby incorporated by reference in its
entirety.
FIELD OF THE DISCLOSURE
[0001] The present disclosure relates to nutritional compositions including a
stabilizer system that provides improved emulsion stability and reduced precipitation
without retrogradation. More particularly, the present disclosure relates to liquid
nutritional compositions including a stabilizer system. The stabilizer system may
comprise a starch or a combination of starch and maltotriose.
BACKGROUND OF THE DISCLOSURE
[0002] Manufactured liquid nutritional compositions, also commonly
referred to as nutritional liquids, comprising a targeted selection of nutrition
ingredients are well known and widely available, some of which may provide a sole
source of nutrition while others may provide a supplemental source. These nutritional
liquids include powders that can be reconstituted with water or other aqueous liquid,
as well as concentrated liquids and ready to drink nutritional liquids such as milk or
protein based emulsions or non-emulsified or substantially clear liquids for use in
infant and pediatric formulas and medical and adult nutritionals.
[0003] Traditionally, native starches have been included in food
applications, and particularly in liquid nutritional emulsions and other liquids, for
their ability to stabilize emulsions and suspensions, increase viscosity, reduce
sedimentation, form film networks, and gelatinize. More particularly, these desired
gelatinization and stable network formation abilities of natural starches occur with
heat after starch granules are fully hydrated. Gelatinized starch molecules, however,
also tend to re-associate over time, squeezing water out and causing recrystallization
(also referred to herein as retrogradation). The retrogradation effect is a result of
starch chains forming ordered chain structures that result in chain aggregation, which
is revealed as phase separation in liquid nutritionals.
[0004] The retrogradation tendency of starches limits their functionality in
food applications as it shortens the resulting shelf life of the product. Retrogradation
may be further exaggerated with temperature fluctuations similar to those seen in
process conditions during the manufacturing and sterilization of nutritional liquids.
[0005] To combat the undesired retrogradation effect, many native starches
are chemically modified to reduce chain formation in liquid nutritionals as described
above. Although this approach has had some success, such chemical modification
may present issues with multiple regulatory bodies around the world that do not
generally approve of the use of chemically modified starches in nutritional liquids,
and particularly in infant nutritional liquids.
[0006] Accordingly, there is a need in the art for alternative stabilizer
systems that can provide improved emulsion stabilization and reduced precipitation
without the drawbacks of retrogradation and reassociation. Additionally, it would be
advantageous if the stabilizer system was carrageenan-free as such stabilizer systems
including carrageenan are not universally accepted from a regulatory standpoint
around the world.
[0007] The present disclosure is directed to nutritional compositions,
particularly in the form of liquid nutritional compositions comprising starch. The
stabilizer system may comprise starch, more particularly waxy starch, more
particularly, a native waxy starch such as a native hybrid waxy potato starch. In
addition, or in the alternative, the stabilizer system may be a dual stabilizer system
including a starch and maltotriose. These nutritional compositions provide improved
stability, longer shelf life, and are universally label friendly from a regulatory
standpoint.
SUMMARY OF THE DISCLOSURE
[0008] The present disclosure is generally directed to a stabilized solid
(capable of being made into a liquid by reconstitution) or liquid nutritional
composition comprising a stabilizer system such that the nutritional composition has
improved emulsion stability and suspension properties. In some embodiments, the
stabilizer system comprises, consists of, or consists essentially of starch and
maltotriose. In a further embodiment, the stabilizer system comprises, consists of, or
consists essentially of a native hybrid waxy potato starch. In any of the embodiments,
the stabilizer system can be carrageenan and/or cellulose gum free. The nutritional
composition may be designed to be suitable for use as an infant nutritional
composition, such as a preterm infant liquid nutritional composition, or an adult liquid
nutritional composition.
[0009] The present disclosure is further directed to a liquid nutritional
composition, such as a liquid infant formula, comprising a stabilizer system. In some
embodiments, the stabilizer system comprises, consists of, or consists essentially of
starch, and maltotriose. In some embodiments, the stabilizer system comprises,
consists of, or consists essentially of a native hybrid waxy potato starch. The present
disclosure is further directed to a stabilized liquid infant formula comprising a
stabilizer system and at least one of a protein, a fat and a carbohydrate.
[0010] The present disclosure is further directed to a process for
manufacturing a stabilized liquid nutritional composition, such as a liquid infant
formula. In some embodiments, the process comprises introducing a starch and
maltotriose and/or introducing a native hybrid waxy potato starch, into a liquid
nutritional composition comprising at least one of protein, fat, and carbohydrate and
heating the liquid nutritional composition to form the stabilized liquid nutritional
composition.
[001 1] In some embodiments, the process comprises introducing maltotriose
into a carbohydrate-mineral slurry and mixing the carbohydrate-mineral slurry with at
least one of a protein-in- water slurry and a protein-in-fat slurry to form a liquid
nutritional composition and introducing a starch into the liquid nutritional
composition and heating the liquid nutritional composition including the starch to
form the stabilized liquid nutritional composition.
[0012] The present disclosure is further directed to a stabilized liquid infant
formula comprising a stabilizer system, a protein component, a fat component, and a
carbohydrate component. The stabilizer system comprises a native hybrid waxy
potato starch. The protein component comprises skim milk and whey protein
concentrate. The fat component comprises soy oil, coconut oil, and medium chain
triglyceride oil. The carbohydrate component comprises corn syrup solids and
lactose.
[0013] The stabilized nutritional compositions as described herein not only
provide sufficient nutritional benefits for individuals, including both infants and
adults, but also allow for the use of an improved stabilizer system that may be
universally label friendly. It has been unexpectedly found that when starch is used in
a stabilizer system, either alone or in combination with an additional stabilizer, the
retrogradation effect commonly seen with starch stabilizers is substantially reduced or
even eliminated such that the liquid nutritional composition remains stable for an
extended period of time.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 is a graph depicting step rate measurements as obtained in
Example 2.
[0015] FIG. 2 is a graph depicting strain sweep measurements as obtained in
Example 2.
[0016] FIG. 3 is a graph depicting frequency sweep measurements as
obtained in Example 2.
[0017] FIG. 4 is a graph depicting temperature rate measurements as
obtained in Example 2.
[001 8] FIG. 5 is a graph depicting strain sweep measurements for various
infant nutritional emulsions including starches as analyzed in Example 3.
[0019] FIG. 6 is a graph depicting strain sweep measurements for various
infant nutritional emulsions including starches as analyzed in Example 4.
[0020] FIG. 7 depicting strain sweep measurements as obtained in Example
5.
[0021] FIG. 8 is a graph depicting strain sweep measurements for infant
nutritional emulsions including ELIANE™ food starch as analyzed in Example 6.
[0022] FIGS. 9A-9G are light microscopy photographs of various starches
upon being gelatinized as analyzed in Example 7.
DETAILED DESCRIPTION OF THE DISCLOSURE
[0023] The liquid nutritional compositions of the present disclosure
comprise a stabilizer system including a starch. In some embodiments, the stabilizer
system comprises starch and maltotriose. The starch may be a native (nonchemically
modified) waxy starch and in some embodiments, a native hybrid waxy
potato starch. In some embodiments, native hybrid waxy potato starch is the sole
stabilizer in the liquid nutritional composition, while in other embodiments the native
hybrid waxy potato starch is used in combination with other stabilizers. In some
embodiments, the stabilizer system is a combination of starch and maltotriose, which
results in a long term stable liquid nutritional composition that has reduced
sedimentation.
[0024] The stabilizer system including starch and in some embodiments,
further comprising maltotriose, address a primary problem with liquid nutritional
compositions and provides significant advantages over conventional starch-based
stabilizers that over time can allow sedimentation and phase separation to occur in the
liquid nutritional composition. When a stabilizer system of the present disclosure is
in the liquid nutritional composition, precipitation is substantially minimized or even
eliminated in some embodiments, while emulsion stability and viscosity is
maintained. This reduction/elimination of precipitation and enhanced emulsion
stability and viscosity is maintained even in liquid nutritional compositions that have
very high concentrations of insoluble solutes. The described stabilizer systems
provide the additional advantage of performing very well in the absence of
carrageenan such that the liquid nutritionals can be formulated to be carrageenan-free.
This may allow liquid nutritional compositions, including liquid infant formulas, to be
prepared that are emulsion stable over time, free or nearly free of sedimentation, and
universally accepted from a regulatory standpoint, thus providing significant
commercial advantages.
[0025] These and other features of the liquid nutritional compositions, as
well as some of the many optional variations and additions, are described in detail
hereafter.
[0026] The genus "starch" as used herein, unless otherwise specified,
includes the species: "waxy starch," "native waxy starch," and "native hybrid waxy
potato starch."
[0027] The term "nutritional product" as used herein, unless otherwise
specified, refers to nutritional liquids and nutritional powders, the latter of which may
be reconstituted to form a nutritional liquid, all of which comprise one or more of fat,
protein, and carbohydrate and are suitable for oral consumption by a human.
[0028] The terms "liquid nutritional composition," "liquid nutritionals," and
"nutritional liquid" are used interchangeably herein, and unless otherwise specified,
refer to nutritional products in ready-to-drink liquid form and concentrated form.
[0029] The terms "substantially clear nutritional liquid" and "non-emulsion"
as used herein, unless otherwise specified, are used interchangeably to refer to a nonemulsified
or similar other liquid having a visibly clear or translucent appearance,
which liquid may and typically will have a thin or watery texture with a consistency
similar to that of a clear juice and most typically having a viscosity of less than about
25 centipoises as determined by a Brookfield viscometer at 22°C using a # 1 spindle at
60 rpm.
[0030] The terms "stabilizer" or "stabilizer system" refer to one or more
components of a nutritional product that prevents retrogradation of the nutritional
product for a period of at least 12 hours, including at least 24 hours, including at least
48 hours, including at least 7 days, including at least 1 month, including at least 2
months, including at least 4 months, including at least 6 months, and including at least
9 months, 12 months, 18 months, or longer.
[003 1] 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.
[0032] The terms "stable" and "shelf stable" as used herein, unless otherwise
specified, refer to a liquid nutritional composition that remains commercially stable
after being packaged and then stored at 18-24°C for at least 3 months, including from
about 6 months to about 24 months, and also including from about 12 months to about
18 months.
[0033] The terms "retort packaging" and "retort sterilizing" are used
interchangeably herein, and unless otherwise specified, refer to the common practice
of filling a container, most typically a metal can or other similar package, with a
liquid nutritional composition and then subjecting the liquid-filled package to the
necessary heat sterilization step, to form a sterilized, retort packaged, liquid
nutritional product.
[0034] The term "aseptic packaging" as used herein, unless otherwise
specified, refers to the manufacture of a packaged product without reliance upon the
above-described retort packaging step, wherein the liquid nutritional composition and
package are sterilized separately prior to filling, and then are combined under
sterilized or aseptic processing conditions to form a sterilized, aseptically packaged,
liquid nutritional product.
[0035] The term "infant formula" as used herein, unless otherwise specified,
refers to liquid or solid infant formulas and toddler formulas, wherein infant formulas
are intended for infants up to about 1 year of age and toddler formulas are intended
for children from about 1 year of age to about 10 years of age.
[0036] The term "preterm infant formula" as used herein, unless otherwise
specified, refers to liquid or solid nutritional compositions suitable for consumption
by a preterm infant. The term "preterm infant" as used herein, refers to a person born
prior to 36 weeks of gestation.
[0037] The term "adult nutritional product" as used herein includes
formulas, including, but not limited to liquid formulas, for generally maintaining or
improving the health of an adult, and includes those formulas designed for adults who
need to control their blood glucose.
[0038] 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.
[0039] 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.
[0040] 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.
[0041] The various embodiments of the nutritional products of the present
disclosure may also be substantially free of any optional or selected ingredient or
feature described herein, provided that the remaining nutritional product 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 product contains less than a functional amount of the optional ingredient,
typically less than about 1%, including less than about 0.5%, including less than about
0.1%, and also including zero percent, by weight of such optional or selected
ingredient.
[0042] The nutritional product may comprise, consist of, or consist
essentially of the elements of the products as described herein, as well as any
additional or optional element described herein or otherwise useful in nutritional
product applications.
Product Form
[0043] The nutritional products include both ready-to-feed liquids and
concentrated liquids and liquids derived from nutritional powders (reconstituted
liquids). The liquids may include solutions, suspensions, and emulsions, including
clear solutions/suspensions that may be fat-free. The powders that are reconstituted to
produce a liquid may include any flowable or scoopable particulate solid that can be
diluted with water or other aqueous liquid to form a nutritional liquid prior to use.
[0044] The nutritional products may be formulated with sufficient kinds and
amounts of nutrients to provide a sole, primary, or supplemental source of nutrition,
or to provide a specialized nutritional product for use in individuals afflicted with
specific diseases or conditions or with a targeted nutritional benefit.
[0045] The nutritional products of the present disclosure comprising starch
include human milk fortifiers, preterm and term infant formulas, pediatric and toddler
formulas, follow-on formulas and adult nutritionals, medical nutritionals, sports
nutritional formulas, and sports drinks, all of which may be in liquid or powdered
form.
Nutritional Powders
[0046] The nutritional powders including starch may be reconstituted by the
intended user with a suitable aqueous liquid, typically water or other aqueous liquid,
in an amount or volume sufficient to form a nutritional liquid for immediate oral or
enteral use. The starch present in the reconstituted liquid will improve the emulsion
stability and suspension characteristics of the reconstituted liquid.
[0047] In this context, "immediate" use generally means within about 48
hours, more typically within about 24 hours, most typically right after or within 20
minutes of reconstitution. Further, when reconstituted, the nutritional powders
provide the desired ingredient concentrations as described hereinafter for the
nutritional liquid embodiments.
[0048] The nutritional powders may include spray dried powders, dry mixed
powders, agglomerated powders, combinations thereof, or powders prepared by other
suitable methods. The starch may be included in the nutritional powders by either
adding the native starch to one or more liquid slurries prior to the slurries being spray
dried or it may be dry-blended into a base powder.
Nutritional Liquids
[0049] The nutritional liquids may be formulated in a variety of forms,
including emulsions such as oil-in-water, water-in-oil, or complex aqueous emulsions,
although such emulsions are most typically in the form of oil-in-water emulsions
having a continuous aqueous phase and a discontinuous oil phase, suspensions, or
clear or substantially clear liquids. The stabilizer systems of the present disclosure
improve the emulsion stability and suspension characteristics of the nutritional
liquids.
[0050] The nutritional liquids may be and typically are shelf stable. 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 liquid.
[005 1] The nutritional liquids may have a caloric density tailored to the
nutritional needs of the ultimate user, although in most instances the liquids comprise
generally at least 19 kcal/fl oz (660 kcal/liter), more typically from about 20 kcal/fl oz
(675-680 kcal/liter) to about 25 kcal/fl oz (820 kcal/liter), even more typically from
about 20 kcal/fl oz (675-680 kcal/liter) to about 24 kcal/fl oz (800-810 kcal/liter).
Generally, the 22-24 kcal/fl oz formulas are more commonly used in preterm or low
birth weight infants, and the 20-21 kcal/fl oz (675-680 to 700 kcal/liter) formulas are
more often used in term infants. In some embodiments, the liquid may have a caloric
density of from about 100 kcal/liter to about 660 kcal/liter, including from about 150
kcal/liter to about 500 kcal/liter.
[0052] The nutritional liquid 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 4.5 to about 7.0, including from about 4.5 to about 6.7, including from
about 4.5 to about 6.5, and including from about 4.5 to about 6.0. In some
embodiments, the pH range includes from about 5.5 to about 7.3, including from
about 5.5 to about 7.0, including from about 5.5 to about 6.5, and including from
about 5.5 to about 6.0. In still other embodiments, the pH range may be from about
6.2 to about 7.2, including from about 6.2 to about 7.0, and including from about 6.2
to about 6.5.
[0053] Although the serving size for the nutritional liquid can vary
depending upon a number of variables, a typical serving size is generally at least 2
mL, or even at least 5 mL, or even at least 10 mL, or even at least 25 mL, including
ranges from about 2 mL to about 300 mL, including from about 4 mL to about 250
mL, and including from about 10 mL to about 240 mL.
Starch Component of the Stabilizer System
[0054] In some embodiments, the nutritional liquids include a stabilizer
system including starch and maltotriose. In some embodiments, the nutritional liquids
comprise at least one native (non-chemically modified) starch. In some embodiments,
the nutritional liquids comprise at least one waxy starch. In some embodiments, the
nutritional liquid comprises at least one hybrid waxy potato starch. As used herein,
the term "hybrid" means the offspring of two plants, such as two potato plants, of
different breeds, varieties or species. The native hybrid waxy potato starch in the
liquid nutritional is both a stabilizer as described herein and a carbohydrate nutritional
component, as noted below.
[0055] The stabilizer system may comprise, consist essentially of, or consist
of starch and maltotriose. In some embodiments, the stabilizer may comprise native
hybrid waxy potato starch. In some embodiments, starch may be used in combination
with other, conventionally known stabilizers such as xanthan gum, carrageenan, and
the like. In some embodiments, the nutritional composition including the native
hybrid waxy potato starch is substantially carrageenan-free. In other embodiments,
the nutritional product including the native hybrid waxy potato starch is substantially
cellulose gum-free. In these embodiments, the term "substantially free" means no
more than a trace amount that would not impact the properties of the product, and
include a zero amount.
[0056] In some embodiments, the liquid nutritional products of the present
disclosure comprise a stabilizer system including a waxy starch and maltotriose, and
in some embodiments include only a waxy starch and maltotriose, such that the liquid
nutritional only contains a waxy starch and maltotriose as the stabilizer. The waxy
starch component may be any starch known for use in oral nutritional products, and
may include, for example, waxy and non-waxy starches, including native waxy and
native non-waxy starches, all of which can serve as both a nutritional component as
well as a stabilizer. Exemplary waxy and non-waxy starches include native waxy and
non-waxy potato starch, native waxy and non-waxy wheat starch, native waxy and
non-waxy corn starch, native waxy and non-waxy rice starch, and the like.
Additionally, modified (including chemically modified) waxy and non-waxy starches
can be used with maltotriose in the stabilizer system, in some embodiments in
accordance with the present disclosure.
[0057] One particularly suitable starch is a waxy starch, including a native
(non-chemically modified) hybrid waxy potato starch. Native hybrid waxy potato
starches have now been unexpectedly found to be advantageous stabilizers for
nutritional products, and in particular, liquid nutritional compositions, as waxy potato
starches obtained from native potato hybrids may, in some embodiments,
advantageously be prepared to have a very low (less than 20% by weight) amylose
content, large (greater than about 5 mih) granule size, and low (less than 0.07% by
weight) protein content, all of which may provide beneficial emulsion stability and
suspension properties in liquid nutritionals as described in detail below.
[0058] Utilizing a native hybrid waxy potato starch with a low amylose
content as a stabilizer in a liquid nutritional composition may allow for a reduced
possibility of retrogradation in the resulting nutritional liquid as amylase is a generally
linear carbohydrate polymer that may tend in some nutritional solutions to
symmetrically align against itself and thus have a repulsion effect on other
components, which can lead to retrogradation such that emulsion stability and
suspension properties are reduced. As such, in some embodiments of the present
disclosure, the native hybrid waxy potato starch for use in the nutritional
compositions of the present disclosure will have an amylose content of less than 20%,
including less than 10%, including less than 5%, including less than 4%, including
less than 3%, including less than 2%, and including less than 1% by weight.
[0059] Additionally, the large granular size and branching of any
amylopectin polymers present, which may retard retrogradation due to their branched
structure, in the native hybrid waxy potato starch may provide for a cohesive, stronger
network formation when the starch is heated, such as during retort or aseptic
processing of the final nutritional product, and thus, further inhibit the potential
retrogradation effect. Using larger granular sizes of the native hybrid waxy potato
starch may provide for slower mobility of many carbohydrate polymers present in the
liquid, which can also further inhibit retrogradation and the resulting unwanted
emulsion and sedimentation effects. Suitable large granular sizes include typically
from about 5 m h to about 100 m h, including from about 10 mih to about 100 m , ·
including from about 20 mih to about 100 mhi, including from about 30 m to about
100 m i, including from about 50 m h to about 90 mih, including from about 50 mpi to
about 80 m h.
[0060] In addition to the benefit of a reduction in retrogradation effect, the
starch used in the nutritional products described herein has a relatively low protein
content, thus allowing the resulting liquid nutritional products to have reduced
incidences of allergic reactions. This is particularly desirable when the nutritional
product is to be used in infant and preterm infant nutritional products. The starch for
use in the nutritional products of the present disclosure has a protein content by
weight of less than 0.07%, including less than 0.05%, and including less than 0.04%,
including less than 0.03%, including less than 0.02%. In some embodiments, the
protein content by weight is from about 0.02% to about 0.07%, including from about
0.02% to about 0.05%.
[0061] Additionally, the starch includes phosphorus, generally
present in the form of phosphate monoesters. Phosphate monoesters are negatively
charged molecules, and thus may increase the repulsion of many polymers from each
other such that the polymers present are less likely to align as described above and
cause retrogradation. This repulsion phenomena may cause an increase in water
binding capacity, swelling power and paste clarity as the network formation is
improved as the starch molecules are less likely to associate.
[0062] The amount of starch in the nutritional products to provide
sufficient stabilization will generally depend on the product form, other components
of the nutritional product and/or the targeted use of the nutritional product.
[0063] One suitable native hybrid waxy potato starch for use in the
nutritional compositions of the present disclosure is commercially available as an
ELIANE™ native hybrid waxy potato starch, available from Avebe Food (The
Netherlands).
[0064] For powdered nutritional compositions that are reconstituted with a
liquid prior to use, embodiments comprising suitable amounts of starch in the powder
may range from about 0.05% by weight to about 20% by weight total nutritional
product, including from about 2.0% by weight to about 15% by weight total
nutritional product, and including from about 5% by weight to about 8% by weight
total nutritional product. In one specific embodiment, when used in powdered infant
nutritional products, suitable amounts of native hybrid waxy potato starch in the
powder may include from about 0.05% by to about 5.0% by weight total nutritional
composition, including from about 1.0% by weight to about 5.0 % by weight total
nutritional composition.
[0065] In embodiments comprising starch and maltotriose components of the
stabilizer system, suitable amounts of starch may range from about 0.05% by weight
to about 60% by weight total nutritional product, including from about 0.1% by
weight to about 15% by weight total nutritional product, and including from about
0.5% by weight to about 2% by weight total nutritional product. More particularly,
when used in infant nutritional products, suitable amounts of starch may include no
more than 2% by weight total infant nutritional product, including from 0.5% by
weight to 2% by weight total infant nutritional product.
[0066] Liquid nutritional products may be either in ready to drink or
concentrated form. Suitable amounts of native hybrid waxy starch may range from
about 0.5% by weight to about 15% by weight of the total nutritional product
including from about 0.5% to about 10% by weight total nutritional product and
including from about 1.0% by weight to about 5.0% by weight total nutritional
product. In one specific embodiment, when used in ready-to-drink or concentrated
liquid infant nutritional products, suitable amounts of native hybrid waxy potato
starch may include no more than 2% by weight total liquid infant nutritional product,
including from about 0.5% to about 2% by weight total liquid infant nutritional
product, including from about 0.5% to about 1.4% by weight liquid infant nutritional
product, including about 0.8% by weight total liquid infant nutritional product.
Maltotriose Component of the Stabilizer System
[0067] The stabilizer system of the nutritional products may include
maltotriose in combination with the starch. Maltotriose is a polyhydroxy compound,
and particularly a trisaccharide, consisting of three glucose molecules linked with -
1,4 glycosidic bonds as shown in the formula below.
[0068] Maltotriose is most commonly produced by the digestive enzyme
alpha-amylase on amylose in starch. The creation of both maltotriose and maltose
during this process is due to the random manner in which alpha-amylase hydrolyses
a-1,4 glycosidic bonds.
[0069] Maltotriose may be found in some maltodextrin sources. The
percentage of maltotriose in conventional maltodextrin sources, however, is relatively
low. A particularly suitable maltotriose source includes maltodextrin including about
50% by weight maltotriose, available from National Starch (Bridgewater, New
Jersey).
[0070] The amount of maltotriose in the nutritional product will typically
depend on the amount and type of starch present in the nutritional product. For
example, higher concentrations of maltotriose may be required when non-waxy
starches are used as the starch in the nutritional product. The nutritional products
typically include maltotriose in an amount of from about 0.01% by weight to about
15% by weight, including from about 0.01% by weight to about 10%> by weight, and
including from about 0.01% by weight to about 2%> by weight total nutritional
product.
Protein
[0071] The nutritional products may further comprise any proteins or
sources thereof that are suitable for use in oral nutritional products and are compatible
with the essential elements and features of such products. Total protein
concentrations in the nutritional products may 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 product.
[0072] Non-limiting examples of suitable protein or sources thereof for use
in the nutritional products 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 or calcium caseinates, whole
cow's milk, partially or completely defatted milk, soy protein isolates, soy protein
concentrates, and so forth. Particularly preferred protein sources include skim milk,
including condensed skim milk, and whey protein concentrate, alone or in
combination.
[0073] The optional protein in the nutritional products may include soluble
proteins as that term is defined herein to improve product stability and minimize the
development of bitter flavors and after taste in the composition during shelf life.
[0074] The soluble protein may represent up to 100% of the total protein in
the nutritional product, including from about 65%> to 100%, including from 80% to
100%, including from about 85% to about 100%, including from about 90% to about
100% , including from about 95% to about 10 0%, and also including about 10 0% , by
weight of the total protein in the nutritional product. The concentration of soluble
protein may range from at least 0.5%, including from about 1% to about 30%o, and
also including from about 2% to about 15%, also including from about 3%o to about
10% , and also including from about 3% to about 5%, by weight of the nutritional
liquid.
[0075] The term "soluble protein" as used herein, unless otherwise specified,
refers to those proteins having a protein solubility of at least 40%, including from
50% to 100%, and also including from 60% to 90%, as measured in accordance with
the following process: (1) suspend protein ingredient in purified water at 5.00 g per
100 g of suspension; (2) adjust the pH of the suspension to 3.5 or the desired product
pH (e.g., 4.6 or other) using HCl, phosphoric acid, citric acid or combinations thereof;
(3) stir vigorously at room temperature (20°C-22°C) for 60 minutes; (4) measure total
protein in the suspension by any suitable technique (including the HPLC technique
described below); (5) centrifuge an aliquot of the suspension at 31,000 x g and at
20°C for 1 hour; (6) measure the supernatant for protein by the selected technique as
described in step (4); and (7) calculate protein solubility as the supernatant protein
percentage of the total protein.
[0076] Protein concentrations (per step 4 above) can be measured in the
protein solubility process by any known or otherwise suitable method for determining
such concentrations, many of which are well known in the analytical art. An example
of one such suitable method is by HPLC analysis in accordance with the following
specifications: (1) Column: Shodex KW-804 protein size exclusion chromatography
column, Waters P/N WAT036613; (2) Mobile Phase: 0.05M NaH 2P0 , 0.1 5M NaCl,
pH = 7.0; (3) Flow Rate: 0.3 mL/minute; (4) Temperature: 22°C; (5) Detection: UV at
214 nm; (6) Injection: 10 m ; (7) Run Time: 90 minutes; (8) System Calibration:
protein standard solutions prepared at 0.5 - 3.0 g/L in mobile phase; and (9) Sample
Preparation: dilute to about 1.5 g/L protein with mobile phase.
[0077] 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 whey protein concentrate (>90% solubility), whey protein isolate
(>90% solubility), casein hydrolysate (>60%> solubility), hydrolyzed collagen,
combinations thereof. Non-soluble proteins may of course also be included in the
nutritional products described herein provided that the remaining soluble protein
component is represented in accordance with the requirements as set forth herein.
The composition may be substantially free of proteins other than the soluble protein
as described herein.
[0078] It should be noted that any protein selected for use herein as a soluble
protein should also meet the solubility testing requirements noted above even if the
protein is whey protein concentrate, casein hydrolysate, or other typically soluble
protein since protein solubility can vary significantly with the selection of raw
material lots, sources, brands, and so forth.
[0079] In a particularly desirably embodiment, the protein system includes a
combination of condensed skim milk and whey protein concentrate.
Carbohydrate
[0080] The nutritional products may further comprise any carbohydrates or
sources thereof that are suitable for use in an oral nutritional product and are
compatible with the essential elements and features of such products in addition to the
native hybrid waxy potato stabilizing starch and/or the starch and maltotriose
combination, which is also a carbohydrate component. Carbohydrate concentrations
in the liquid nutritional compositions, for example, may range from about 5% to about
40%, including from about 7% to about 30%, and including from about 10% to about
25%, by weight of the liquid nutritional composition.
[0081] Non-limiting examples of suitable carbohydrates or sources thereof
for use in the nutritional products described herein, in addition to the starch and
maltotriose, may include maltodextrin, glucose polymers, corn syrup, corn syrup
solids, rice-derived carbohydrates, sucrose, glucose, fructose, lactose, high fructose
corn syrup, honey, sugar alcohols (e.g., maltitol, erythritol, sorbitol), artificial
sweeteners (e.g., sucralose, acesulfame potassium, stevia) and combinations thereof.
Lactose and corn syrup solids are particularly preferred carbohydrates, and can be
used alone or in combination in the liquid nutritionals described herein.
[0082] The nutritional products may further comprise any fats or sources
thereof that are suitable for use in an oral nutritional product and are compatible with
the elements and features of such products, most typically as emulsified fat,
concentrations of which may 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 liquid nutritional composition.
[0083] Suitable sources of fat for use herein include any fat or fat source that
is suitable for use in an oral nutritional product and is compatible with the essential
elements and features of such products.
[0084] Non-limiting examples of suitable fats or sources thereof for use in the
nutritional emulsions described herein include coconut oil, fractionated coconut oil,
soy oil, corn oil, olive oil, saffiower 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.
Particularly preferred fats include soy oil, coconut oil, and MCT oil, each of which
may be used alone or in any combination.
[0085] The amount of carbohydrates, fats, and/or proteins in any of the
nutritional products described herein may also be characterized in addition to, or in
the alternative, as a percentage of total calories in the nutritional product as set forth
in the following table. These macronutrients for nutritional products of the present
disclosure are most typically formulated within any of the caloric ranges
(embodiments A-F) described in the following table (each numerical value is
preceded by the term "about").
Protein 15-35 10-30 5-30
Fat 35-55 1-20 2-20
[0086] In one specific example, liquid infant formulas (both ready-to-feed
and concentrated liquids) include those embodiments in which the protein component
may comprise from about 7.5% to about 25% of the caloric content of the formula;
the carbohydrate component may comprise from about 35% to about 50% of the total
caloric content of the infant formula; and the fat component may comprise from about
30% to about 60% of the total caloric content of the infant formula. These ranges are
provided as examples only, and are not intended to be limiting. Additional suitable
ranges are noted in the following table (each numerical value is preceded by the term
"about").
Optional Ingredients
[0087] The nutritional products described herein 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 products 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.
[0088] Non-limiting examples of such optional ingredients include
preservatives, antioxidants, emulsifying agents, buffers, pharmaceutical actives,
additional nutrients as described herein, colorants, flavors, thickeners, additional
stabilizers, and so forth.
[0089] The products may further comprise vitamins or related nutrients, nonlimiting
examples of which include vitamin A, vitamin D, 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.
[0090] The products may further comprise minerals, non-limiting examples
of which include phosphorus, magnesium, calcium, iron, zinc, manganese, copper,
sodium, potassium, molybdenum, chromium, selenium, chloride, and combinations
thereof.
[0091] The products may also include one or more flavoring or masking
agents. Suitable flavoring or masking agents include natural and artificial sweeteners,
sodium sources such as sodium chloride, and hydrocolloids, and combinations
thereof.
Methods of Manufacture
[0092] The nutritional products as described herein may be manufactured by
any known or otherwise suitable method for making the nutritional product form
selected. Nutritional liquids may be prepared, for example, by any of the well known
methods of formulating nutritional liquids by way of retort, aseptic packaging, or hot
fill processing methods. Such methods are well known in the nutrition formulation
and manufacturing arts.
[0093] 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 oil (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 CHOMIN
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 agent. The resulting CHO-
MG 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., HMOs, fructooligosaccharide, sucrose, corn syrup,
etc.). The PIW slurry is then formed by mixing with heat and agitation the remaining
protein, if any.
[0094] The resulting slurries are then blended together with heated agitation
and the pH adjusted to 6.6-7.0, after which the composition is subjected to hightemperature
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. This emulsion can then be further diluted, heat-treated, and
packaged to form a ready-to-feed or concentrated liquid.
[0095] To form the stabilized liquid nutritional composition, the starch, or
the starch and maltotriose can be introduced into the liquid nutritional composition
prior to or after heat treatment. For example, in one embodiment, the starch or starch
and maltotriose is introduced into the liquid nutritional composition formed from the
blend of slurries described above, and then the liquid nutritional composition,
including the starch or the starch and maltotriose, is heated to form the stabilized
liquid nutritional composition. The liquid nutritional composition, including the
starch or starch and maltotriose, is heated to a temperature of from about 55°C to
about 70°C for a period of from about 30 minutes to about 90 minutes to form the
stabilized liquid nutritional composition.
[0096] In one embodiment, native hybrid waxy potato starch may be
hydrated to provide partial network formation prior to being introduced, in some
embodiments with maltotriose, into the liquid nutritional composition. The starch
may be hydrated at a temperature of from about 55°C to about 70°C for a period of
from about 15 minutes to about 30 minutes to form the partial network. Typically, the
starch is hydrated to a solids level of about 30%. Hydration and partial network
formulation may then be completed by applying heat.
[0097] In one alternative embodiment, the maltotriose may be added into the
CHO-MIN slurry and included in the resulting liquid nutritional composition. The
starch is then introduced into the liquid nutritional composition, including the
maltotriose, as described above.
[0098] In another embodiment, the nutritional composition is a solid
nutritional composition such as a nutritional powder. Any methods known in the
nutritional art for preparing nutritional powders may be used herein. By way of
example, the nutritional powders can be prepared by drying the heated, homogenized
liquid nutritional composition described above, such as by spray drying.
[0099] In one embodiment, the starch may first be hydrated and heated as
described above and then dried to form a powdered, gelatinized starch. The dry
powdered starch and maltotriose may then be dry-blended with a dry nutritional base
powder.
Methods of Use
[00 100] The nutritional compositions comprising the stabilizer systems
disclosed herein show minimal to no retrogradation effects, providing for improved
stabilization and enhanced shelf life of the compositions while providing nutrition to
individuals. As noted herein, the nutritional compositions including the stabilizer
system described herein are suitable for use as numerous types of nutritional products,
including preterm infant formulas, term infant formulas, pediatric formulas, toddler
formulas and adult formulas. The nutritionals are desirably formulated as liquid
nutritionals and can have the added benefit of being substantially or completely
carrageenan-free.
[00101] The methods of the present disclosure include the use of desirable
embodiments as described herein. In one embodiment, the stabilizer system
comprising starch and the stabilizer system comprising starch and maltotriose is a
liquid nutritional composition comprising a protein, a carbohydrate, and a fat. The
protein component includes skim milk, optionally in the form of condensed skim
milk, and whey protein concentrate. In embodiments in which the stabilizer system
comprises hybrid waxy potato starch, the carbohydrate component additionally
includes corn syrup solids and lactose. The fat component includes a combination of
coconut oil, soy oil, and medium chain triglyceride (MCT) oil. This is a particularly
desirable embodiment that may also include vitamins, and minerals, as well as a
source of DHA and ARA oil. This particularly preferred embodiment is carrageenanfree.
EXAMPLES
[00102] The following examples illustrate specific embodiments and or
features of the nutritional compositions 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.
[00103] The exemplified compositions are nutritional products that may be
prepared in accordance with manufacturing methods well known in the nutrition
industry for preparing nutritional emulsions, non-emulsions (e.g., substantially clear
nutritional liquids), and nutritional powders.
Example 1
[00104] In this Example, ready-to-drink liquid infant formulas including a
native hybrid waxy potato starch as described above were prepared and evaluated.
The formulas were visually inspected for retrogradation effect.
[00105] Ready-to-drink liquid infant formulas (Similac® Special Care 24
HP) were prepared including 1.8% by weight ELIANE™ native hybrid waxy potato
starch. The formulas, 20 bottles for each storage condition, were stored for one
month in conditioning rooms at a temperature of 5°C, 37°C, and 45°C. Visual
inspection of these infant liquid formulas at the end of the condition period
surprisingly showed that none of the liquid infant formulas including the native hybrid
waxy potato starch exhibited any retrogradation. There was no phase separation
and/or sedimentation observed.
Example 2
[00106] In this Example, infant nutritional emulsions including a waxy
potato starch, with or without maltotriose, were prepared as described. The
rheologies of the resulting emulsions were analyzed for retrogradation effect.
[00107] Samples of a commercially available liquid infant formula were
prepared adding 1.8% by weight waxy potato starch with (sample C34-7) or without
(sample C34-1) 0.5% by weight maltotriose. Four rheologies measurements
(frequency sweep measurements, step rate measurements, strain sweep measurements
and temperature sweep measurements) of the samples were analyzed using an ARESLS1
rheometer, available from TA Instruments (New Castle, Delaware).
[00108] Step rate measurements were obtained by analyzing shear rate
viscosity at 25°C. The shear viscosities at shear rates of 0.5s 1, 13s 1, and 100s 1 were
recorded for 1 0 seconds. The last 90 seconds were averaged to obtain the viscosity
value. The values from duplicate measurements were averaged. The results are
shown in FIG. 1.
[00109] Strain sweep measurements are obtained by recording dynamic
modulus as a function of strain at 25°C. The linear range in this data corresponds to
elastic modulus wherein change as a function of strain is insignificant. The line fit is
performed to identify the plateau elastic modulus. The frequency of the measurement
is 10 rad/s. The plateau elastic moduli from duplicate measurements were averaged.
The results are shown in FIG. 2.
[001 10] Frequency sweep measurements were obtained using the plateau G'
from the strain sweep measurements. The zero shear viscosity was calculated via the
Ellis model. The results are shown in FIG. 3.
[001 11] The temperature rate measurements are a rheology measurement as
a function of temperature. Particularly, the determined G'p from the strain sweep
measurement was used for the temperature rate measurements. The frequency of the
measurements was 10 rad/s. The moduli values from duplicate measurements were
averaged. The results are shown in FIG. 4.
[0112] As shown in FIGS. 1-3, there was seen almost no difference in
product qualities as the viscoelasticity of the products at room temperature were
similar within the frequency domain (inverse of time). As shown in FIG. 4, however,
at elevated temperatures the emulsion containing only the waxy potato starch (C34-1)
started to develop elasticity and viscosity, indicating gel network build-up, while the
emulsion containing starch and maltotriose (C34-7) showed a steady decline as a
function of increased temperature. For example, product viscosity and elasticity at
around 67°C were, respectively, 149.3 mPa and 52.6 mPa for C34-1, and 101.2 mPa
and 18.8 mPa for C34-7. These results indicate that the addition of maltotriose
prevents the retrogradation effect, particularly at elevated temperature conditions.
Example 3
[001 13] In this Example, multiple liquid infant nutritional emulsions
including various types of starches were prepared and analyzed for
emulsion/suspension stability.
[00114] Seven liquid infant nutritional emulsions were prepared using the
starches as shown in the table below. Particularly, the starches were fully hydrated
and heated to a temperature of about 150°F (65.6°C) for a period of about 5 minutes
to allow for partial network formation. The aqueous heated starch slurry was then
added to 15 mL samples of a commercially available ready-to-drink liquid infant
formula.
[001 15] Strain sweep measurements for each sample were then obtained
using an ARES-LSI rheometer, available from TA Instruments (New Castle,
Delaware). For a sample to exhibit good emulsion/suspension stability, the strain
sweep would display a long linear range (no significant change in amplitude as a
function of frequency) and a large plateau amplitude. Additionally, the strain sweep
may identify undesirable sharp breaks in the plateau moduli which may indicate a gel
like structure. The results of the strain sweep measurements of the samples are shown
in FIG. 5.
[001 16] Strain sweep measurements are obtained by recording dynamic
modulus as a function of strain at 25°C. The linear range in this data corresponds to
elastic modulus wherein change as a function of strain is insignificant. The line fit is
performed to identify the plateau elastic modulus. The frequency of the measurement
is 10 rad/s. The plateau elastic moduli from duplicate measurements were averaged.
The results are shown in FIG. 5.
[001 17] As shown in FIG. 5, surprisingly the sample that exhibited good
emulsion/suspension stability (i.e., no retrogradation) was the sample including the
native hybrid waxy potato starch (CI 6-6). The other samples showed effects of
gelling or no emulsion/suspension stability as indicated by sharp or short declines in
strain sweep profiles (i.e., no linear range). This data indicates that the native hybrid
waxy potato starch provides excellent stabilization properties.
Example 4
[001 18] In this Example, liquid infant nutritional emulsions including
varying starches were prepared and analyzed for emulsion/suspension stability.
[00 119] Seven liquid infant nutritional emulsions were prepared using the
starches as shown in the table below. The starches were added directly to 15 mL
samples of a commercially available ready-to-drink liquid infant formula and the
samples were then heated to a temperature of about 150°F (65.6°C) for a period of
about 15 minutes. The samples were then subjected to a conventional retort
processing process.
amylose
CI 8-6 Modified Waxy Corn Novation™ 5600 0.8
CI 8-7 Waxy Corn Amioca 0.8
[00120] Strain sweep measurements for each sample were then obtained as
described in Example 3. The results are shown in FIG. 6.
[00121] As shown in FIG. 6, the two samples showing good product quality
in strain sweep measurements were the samples including the waxy corn starch
(Amioca) and the native hybrid waxy potato starch.
[00122] Further, the shear viscosity for each sample was measured using an
ARES-LSI rheometer, available from TA Instruments. The results are shown in the
table below.
Table: Average viscosity of last 90 seconds
[0123] As indicated by the shear viscosity measurements, there was more
shear thinning in the sample including Amioca, which is typically seen with starch
retrogradation, resulting in a creaming effect. Moreover, sample CI 8-5, including the
native hybrid waxy potato starch, showed improved emulsion stability and suspension
as compared to all other samples evaluated. This data shows that the native hybrid
waxy potato starch provides excellent stabilization properties.
Example 5
[0124] In this Example, various processing conditions for adding a native
hybrid waxy potato starch to infant nutritional emulsions were analyzed and evaluated
to determine optimal processing conditions for the addition of the native hybrid waxy
potato starch.
[0125] Six samples were prepared by adding a native hybrid waxy potato
starch, either directly or after being hydrated and/or heated, to either Similac® Early
Shield or Similac® Special Care 30 (both available from Abbott Nutrition, Columbus,
Ohio). The six samples and their respective processing conditions are shown in the
table below.
Sample Amount of Nutritional Point of Addition Processing
Starch (% bv Emulsion of Starch Conditions (temp
weight) of heat treatment,
time period)
C24-1 0.8 Similac® Early Standardization 150°F, 30 min
Point, heated, and
Shield
then sent to retort
C24-2 0.8 Similac® Early Standardization 160°F, 20 min
Point, heated, and
Shield
then sent to retort
C24-3 0.8 Similac® Early Standardization 170°F, 10 min
Point, heated, and
Shield
then sent to retort
C24-3 0.8 Similac® Early Prior to Blended with
homogenization protein-in-fat slurry
Shield
C24-8 0.8 Similac® Special Standardization 160°F, 20 min
Point, heated, and
Care 30
then sent to retort
C24-9 0.4 Similac® Special Prior to Blended with
homogenization carbohydrate,
Care 30
protein, and fat
slurries
[0126] As shown in FIG. 7, the optimal method of adding the native hybrid
waxy potato starch into the liquid nutritional products is at the standardization point
where the temperature was raised to about 150°F for a period of about 30 minutes
(Sample C24-1).
Example 6
[0127] In this Example, various infant nutritional emulsions were prepared
with 0.8% by weight ELIANE™ food starch, added at standardization directly into
cold formulations and heated to 150°F for a period of 30 minutes prior to retort. The
samples were compared, using strain sweep measurements, to the same infant
nutritional emulsions including carrageenan as the stabilizer.
[0128] -The samples tested are shown in the table below. Strain sweep
measurements for each sample were obtained as described in Example 3. The results
of the strain sweep test for the ELAINE™ food starch-containing formulas are shown
in FIG. 8. Results of the carrageenan-containing formulas are not shown. As shown
in FIG. 8, all of the samples including ELIANE™ food starch exhibited good strain
sweep profiles, indicating improved emulsion/suspension stability. Unexpectedly, a
trend was observed that 0.8% by weight starch addition level provided elevated
stability at elevated caloric emulsions. Furthermore, Similac® Special Care 20,
although one of the lower calorie emulsions, showed the highest stability among the
emulsions where, in the past, this emulsion has demonstrated to be one of the most
difficult emulsions in terms of emulsion/suspension stability.
Example 7
[0129] In this Example, infant nutritional emulsions including various
starches were analyzed microscopically.
[0130] Seven samples were slurried. Starches (indicated in the table below),
at a concentration of about 0.8% by weight of the total batch in 20 gallons of water,
were added to the slurries at standardization and heated treated at 150°F for a period
of 15 minutes. The starch slurries were then added to a sterile infant nutritional
emulsion at high shear and then filled into 8 oz. bottles and retorted. The various
starches used in the samples are shown in the table below.
[0131] The samples were then observed visually. All samples were similar
in color and all samples showed a "creamy ring" at the top of the mixture in the
bottles. The sample with ELIANE™ (C-5) food starch, however, appeared to have
the smallest amount of creamy ring. The sample with Novation™ 5600 (C-6)
appeared to be the worst from a homogeneity standpoint; not only was the creamy
ring the widest of all the samples, but a layer of small particles had separated out of
the bottom inch of the sample.
[0132] The samples were then diluted (approximately :40) in a 3.7 L vial
with distilled water. The samples were stained with 0.1N iodine solution and
evaluated by light microscopy at 200X. The results are shown in FIGS. 9A-9G.
[0133] As shown in FIGS. 9A-9G, samples C-5 and C-7 appeared to have no
intact starch granules, and observation of the samples showed that the formula
consisting of ELIANE™ 100 was the most homogenous of all samples.
Examples 8-12
[0134] Examples 8-12 illustrate nutritional emulsions of the present
disclosure including native hybrid waxy potato starch, the ingredients of which are
listed in the table below. All ingredient amounts are listed as kilogram per
approximately 1000 kg batch of product, unless otherwise specified.
Examples 13-17
Examples 13-17 illustrate nutritional emulsions of the present disclosure
including waxy starch and maltotriose, the ingredients of which are listed in the table
below. All ingredient amounts are listed as kilogram per approximately 1000 kg
batch of product, unless otherwise specified.
WHAT IS CLAIMED IS:
1. A stabilized liquid nutritional composition, preferably a stabilized infant
formula, comprising a stabilizer system, the stabilizer system comprising a
starch, preferably a waxy starch, more preferably a native waxy starch, most
preferably a native hybrid waxy potato starch, the waxy starch comprising less
than 0.04% by of protein.
2. A stabilized liquid nutritional composition of claim 1, wherein the stabilizer
system comprises a waxy starch and maltotriose, wherein the maltotriose is
present from 0.01% to 15% by weight percentage of the composition.
3. A stabilized liquid nutritional composition of either one of claims 2 or 3,
wherein the composition comprises by weight percentage less than at least one
of 1% amylase or amylose.
4. A stabilized liquid nutritional composition of any one of the preceding claims,
wherein the composition comprises the waxy starch in an amount by weight
percentage of the composition of no more than 2%, more preferably from
0.5% to 2% by weight, most preferably 0.8%.
5. A stabilized liquid nutritional composition of any one of the preceding claims,
wherein the waxy starch is present in the composition at a weight percentage
from 0.5% to 15%, preferably 0.8%.
6. A stabilized liquid nutritional composition of any one of the preceding claims,
wherein the composition is carrageenan-free or cellulose gum-free.
7. A stabilized liquid nutrition composition of any one of the preceding claims,
wherein the composition consists essentially of waxy starch and maltotriose.
8. A stabilized liquid infant formula of claim 1 comprising a stabilizer system, a
protein component, a fat component, and a carbohydrate component, the
stabilizer system comprising a native hybrid waxy potato starch, the protein
composition comprising skim milk and whey protein concentrate, the fat
component comprising soy oil, coconut oil, and medium chain triglyceride oil,
and the carbohydrate composition comprising corn syrup solids and lactose.
9. A process for manufacturing a stabilized liquid nutritional composition,
preferably a stabilized infant formula, the process comprising the steps of:
introducing a waxy starch, preferably a native hybrid starch, more
preferably a native hybrid waxy potato starch, into a liquid nutritional
composition comprising at least one of protein, fat, and carbohydrate;
and
heating the liquid nutritional composition including the waxy starch to
form the stabilized liquid nutritional composition.
10. A process for manufacturing a stabilized liquid nutritional composition of
claim 9, wherein maltotriose is introduced into the liquid nutritional
composition such that the liquid nutritional composition in the heating step
comprises waxy starch and maltotriose.
11. A process for manufacturing a stabilized liquid nutritional composition of
either one of claims 9 or 10, wherein the waxy starch is introduced in an
amount of from 0.5% to 15% by weight of the liquid nutritional composition
and the maltotriose is introduced in an amount of from about 0.01% to about
15% by weight of the liquid nutritional composition.
12. A process of any one of claims 9 to 1 , further comprising the step of
hydrating the waxy starch, preferably the native hybrid starch, more preferably
the native hybrid waxy potato starch, prior to introducing the starch into the
liquid nutritional composition, wherein the starch is preferably hydrated at a
temperature from 55°C to 70°C for a period from 15 minutes to 30 minutes
prior to being introduced into the liquid nutritional composition.
13. A process of any one of claims 9 to 12, wherein the waxy starch is introduced
in an amount of no more than 2% by weight of the liquid nutritional
composition.
14. A process of claim 10, further comprising the step of subjecting the heated
liquid nutritional composition comprising the waxy starch and maltotriose to
further processing selected from the group consisting of retort processing and
aseptic processing.
15. A process of claim 9, further comprising the steps of:
introducing maltotriose into a carbohydrate-mineral slurry;
mixing the carbohydrate-mineral slurry with at least one of a proteinin-
water slurry and a protein-in-fat slurry to form the liquid nutritional
composition.
| # | Name | Date |
|---|---|---|
| 1 | 5985-DELNP-2014-AbandonedLetter.pdf | 2019-11-05 |
| 1 | SPECIFICATION FOR FILING.pdf | 2014-07-23 |
| 2 | 5985-DELNP-2014-FER.pdf | 2019-03-26 |
| 2 | FORM 5.pdf | 2014-07-23 |
| 3 | FORM 3.pdf | 2014-07-23 |
| 3 | 5985-delnp-2014-Correspondence Others-(19-11-2015).pdf | 2015-11-19 |
| 4 | Abbott Laboratories,_new Latest GPOA.pdf | 2014-07-23 |
| 4 | 5985-delnp-2014-Form-3-(19-11-2015).pdf | 2015-11-19 |
| 5 | 5985-delnp-2014-Correspondence-Others-(25-07-2014).pdf | 2014-07-25 |
| 5 | 5985-DELNP-2014-Correspondance Others-(23-01-2015).pdf | 2015-01-23 |
| 6 | 5985-DELNP-2014-Form-3-(23-01-2015).pdf | 2015-01-23 |
| 6 | 5985-delnp-2014-Assignment-(25-07-2014).pdf | 2014-07-25 |
| 7 | 5985-DELNP-2014.pdf | 2014-07-26 |
| 7 | 5985-delnp-2014-Correspondence-others-(10-10-2014).pdf | 2014-10-10 |
| 8 | PD013643IN_NP_Marked up copy.pdf | 2014-09-26 |
| 8 | 5985-delnp-2014-Form-3-(10-10-2014).pdf | 2014-10-10 |
| 9 | PD013643IN_NP_Clean copy.pdf | 2014-09-26 |
| 9 | PD013643IN_NP_Form 13.pdf | 2014-09-26 |
| 10 | PD013643IN_NP_Clean copy.pdf | 2014-09-26 |
| 10 | PD013643IN_NP_Form 13.pdf | 2014-09-26 |
| 11 | 5985-delnp-2014-Form-3-(10-10-2014).pdf | 2014-10-10 |
| 11 | PD013643IN_NP_Marked up copy.pdf | 2014-09-26 |
| 12 | 5985-delnp-2014-Correspondence-others-(10-10-2014).pdf | 2014-10-10 |
| 12 | 5985-DELNP-2014.pdf | 2014-07-26 |
| 13 | 5985-delnp-2014-Assignment-(25-07-2014).pdf | 2014-07-25 |
| 13 | 5985-DELNP-2014-Form-3-(23-01-2015).pdf | 2015-01-23 |
| 14 | 5985-DELNP-2014-Correspondance Others-(23-01-2015).pdf | 2015-01-23 |
| 14 | 5985-delnp-2014-Correspondence-Others-(25-07-2014).pdf | 2014-07-25 |
| 15 | 5985-delnp-2014-Form-3-(19-11-2015).pdf | 2015-11-19 |
| 15 | Abbott Laboratories,_new Latest GPOA.pdf | 2014-07-23 |
| 16 | 5985-delnp-2014-Correspondence Others-(19-11-2015).pdf | 2015-11-19 |
| 16 | FORM 3.pdf | 2014-07-23 |
| 17 | 5985-DELNP-2014-FER.pdf | 2019-03-26 |
| 17 | FORM 5.pdf | 2014-07-23 |
| 18 | SPECIFICATION FOR FILING.pdf | 2014-07-23 |
| 18 | 5985-DELNP-2014-AbandonedLetter.pdf | 2019-11-05 |
| 1 | Searchstrategy5985_26-03-2019.pdf |