Note: Descriptions are shown in the official language in which they were submitted.
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HIGH FIBER NUTRITIONAL EMULSIONS
This application makes reference to and claims priority back to U. S.
Provisional Application 611169,022 filed April 14.
2009.
FIELD OF THE INVENTION
(0001) The present invention relates to nutritional emulsions having a low
viscosity
and high fiber concentrations.
BACKGROUND OF THE INVENTION
(0002) There are many different types of milk or protein-based emulsions
suitable for
oral administration to humans as a sole or supplemental nutrition source.
These
emulsions are typically manufactured as oil-in-water emulsions comprising fat,
protein, carbohydrate, vitamins, and minerals. Examples of such emulsions
include
ENSURE Nutritional Liquid and GLUCERNA Shake available from Abbott
Laboratories, Columbus, Ohio USA.
(0003) Many of these nutritional emulsions are manufactured with added fiber
to
provide any of a number of benefits. Proper intake of fiber is believed to
reduce the
risk of developing various conditions such as heart disease, diabetes,
diverticular
disease, and constipation. Fiber is often formulated into nutritional
emulsions to help
reduce the glycemic index of a carbohydrate-containing emulsion, which may be
of
benefit to many individuals, including diabetics as well as individuals
interested in the
many benefits associated with a more modulated glycemic response.
(0004) Given the many benefits of a high fiber diet, it is often recommended
that
children and adults consume at least 20 grams of dietary fiber per day. In
fact, the
more calories an individual consumes each day, the more fiber he or she needs
for a
healthy diet. Teens and men, for example, may require 30-35 grams of fiber per
day
or more, depending upon their specific dietary intake.
(0005) Notwithstanding the need for relatively high fiber content in most
diets, the
average American consumes only about 15 grams of fiber per day, despite the
fortification of many foods with added fiber. There is therefore a need for
nutritional
products, such as protein or milk-based emulsions that are manufactured with
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relatively high fiber concentrations to better meet the nutritional needs of
the typical
consumer.
(0006) The formulation of nutritional emulsions, however, with higher fiber
concentrations often creates a number of issues, some of which are unique to
emulsion-based matrices. High fiber content can impair emulsion stability,
necessitate the need for harsh processing temperatures, reduce
gastrointestinal
tolerance, and create undesirable hedonics such as poor mouth feel,
grittiness, flavor
changes, and so forth.
(0007) There is a need, therefore, for nutritional emulsions that contain
higher fiber
concentrations but also have relatively low and therefore drinkable
viscosities, but
without some or all of the negatives historically associated with high fiber
emulsions.
SUMMARY OF THE INVENTION
(0008) A first embodiment of the high fiber nutritional emulsions comprises
fat,
protein, and carbohydrate, and includes from 1.75% to about 4.0% by weight of
diacylglycerol oil and from about 1.5% to about 9.0% by weight of fiber,
wherein the
emulsion has a viscosity of less than about 300 cps.
(0009) A second embodiment of the high fiber nutritional emulsions comprise
fat,
protein, and carbohydrate, and include 1% to about 4.0% of diacylglycerol oil
by
weight of the aqueous emulsion and from about 2.0 % to about 9.0% of fiber by
weight of the aqueous emulsion, wherein the emulsion has a viscosity of less
than
about 300 cps.
(0010) A third embodiment of the high fiber nutritional emulsions comprise
fat,
protein, and carbohydrate, and include 1% to about 4.0% of diacylglycerol oil
by
weight of the aqueous emulsion and from about 2.0 % to about 9.0% of fiber by
weight of the aqueous emulsion, wherein the nutritional emulsion is contained
within
a package having a majority inner plastic surface in contact with the
nutritional
emulsion, wherein the emulsion has a viscosity of less than about 300 cps_
(0011) A fourth embodiment of the high fiber nutritional emulsions comprise
fat,
protein, and carbohydrate, and include 1.75% to about 4.0% of diacylglycerol
oil by
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weight of the aqueous emulsion and from about 1.5 % to about 9.0% of fiber by
weight of the aqueous emulsion, wherein the emulsion has a viscosity of less
than
about 300 cps and is contained within a package having a majority inner
plastic
surface in contact with the nutritional emulsion.
(0012) These nutritional compositions are aqueous oil-in-water emulsions that,
despite the high fiber content, have desirable physical and chemical stability
under
varied conditions, and desirable hedonics, rheologies, and product
performance,
including a blunted glycemic response profile and or minimal or no
gastrointestinal
intolerance. The emulsions are especially useful when contained within a
package
having a majority interior surface in contact with the nutritional emulsion
that is plastic
rather than metal, glass, or other non-plastic surface.
BRIEF DESCRIPTION OF THE DRAWINGS
(0013) Figure 1 is a graph from Study 1 illustrating fasting plasma insulin
concentrations (mmole/L) at 0, 14 and 28 days in Zucker fa/fa rats fed diets
supplemented with Al, A2 and A3 formulations.
(0014) Figure 2 is a graph from Study I illustrating differences in insulin
sensitivity as
determined by an insulin tolerance test (changes in blood glucose at defined
times
post gavage) for Zucker fa/fa rats supplemented with Al, A2 and A3
formulations.
(0015) Figure 3 is a graph from Study I illustrating glycated hemoglobin (%)
at 0 and
28 days in Zucker fa/fa rats fed diets supplemented with Al, A2 or A3
formulations.
The change in glycated hemoglobin from day 0 to day 28 is indicated by the
upper
section of each charted bar.
(0016) Figure 4 is a graph from Study II illustrating fasting plasma insulin
concentrations (p moI/L) at 0, 14 and 28 days in Zucker fa/fa rats fed a Study
Diet or
the Study Diet voluntarily supplemented with the Al formulation. The graph
shows
that voluntary consumption of the Al formulation attenuated the increase in
plasma
insulin seen in the control group (*: p<0.05).
(0017) Figure 5 is a graph from Study II illustrating blood glucose (mg/dl)
levels at 0,
30, 60, 90, and 120 minutes post insulin injection in Zucker fa/fa rats fed
either a
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Study Diet or the Study Diet voluntarily supplemented with the Al formulation
(p <
0.05).
(0018) Figure 6 is a graph from Study II illustrating glycated hemoglobin (%)
in
Zucker faffa rats at day 0 and 28 of the study in which the rats are fed
either a Study
Diet or the Study Diet voluntarily supplemented with the Al formulation. The
upper
section of the bar is the change in glycated hemoglobin from day 0 to day 28
of the
study. Voluntary consumption of the Al formulation attenuated the increase in
glycated hemoglobin seen in the unsupplemented group.
(0019) Figure 7 is a graph from Study III that shows the total food intake
(kcals) by
Zucker faffa rats fed either a control chow or a semi-purified diet (Study
Diet)
suggesting a preference for the more palatable Study Diet.
(0020) Figure 8 is a graph from Study III that shows cumulative food intake
(kcal) by
Zucker fa/fa rats fed a Study Diet alone or the Study Diet supplemented with
the Al
formulation. The graphs shows that the animals rats chose to decrease
consumption
of the palatable, preferred study diet to compensate for the calories they
consumed
as Al formulation (p<0.05).
DETAILED DESCRIPTION OF THE DISCLOSURE
(0021) The high fiber nutritional emulsions may comprise various combinations
of
diacylglycerol oil, fiber, fructose and leucrose, milk protein concentrate,
and glycerin,
as well as other optional or other components. The essential features of the
nutritional emulsions, as well as some of the many optional variations, are
described
in detail hereafter.
(0022) The term 'nutritional emulsion' as used herein, unless otherwise
specified,
means an aqueous emulsion suitable for oral administration to a human and
comprising fat, protein, carbohydrates.
(0023) The terms 'fat" and coil" as used herein, unless otherwise specified,
are used
interchangeably to refer to lipid materials derived or processed from plants
or
animals.
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(0024) The term "high fiber" as used herein, unless otherwise specified, means
a
fiber concentration of from about 1.5% to about 9%, more typically from about
2.0%
to about 9%, by weight of a nutritional emulsion.
(0025) The term "hedonics" as used herein, unless otherwise specified, may
refer to
one or more of the following properties of the nutritional emulsions: aroma,
mouth
feel, texture, taste, and color or physical appearance.
(0026) The term rheologies" as used herein, may refer to the desirable
viscoelastic
properties of the nutritional emulsion, including those under varied
conditions such as
increased or decreased storage temperatures, to reflect, among other features,
the
enhanced emulsion and or suspension stability of the nutritional emulsions.
(0027) The term "product performance" as used herein, unless otherwise
specified,
may refer to the desirable benefits of the packaged nutritional emulsions
described
herein, wherein such benefits include one or more of increased
gastrointestinal
tolerance, desirably blunted glycemic response at varied times and under
specified
circumstances, increased insulin sensitivity, blunted glycemic response to a
meal,
and desirable product package interactions.
(0028) All viscosity values as referenced herein, unless otherwise specified,
are
obtained using a Brookfield Viscometer (Model DV -11+) with a 62 spindle at
room
temperature (20 C), or at the temperature so designated. 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/cm2, or poise, or
more
typically as centipoise (cps) or one hundredth of a poise.
(0029) 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.
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(0030) As used herein, any reference to a singular characteristic or feature
shall
include the corresponding plural characteristic or feature, and vice versa,
unless
otherwise specified.
(0031) Any combination of method or process steps as used herein may be
performed in any order, unless otherwise specified.
(0032) The various embodiments of the nutritional emulsions may be
substantially
free of any specific ingredient described herein, provided that the remaining
nutritional emulsion comprises all of the essential limitations described
herein. In this
context, the term "substantially free' means the compositions comprise less
than a
functional amount of the identified ingredient disclosed herein, typically
less than
about 1.0%, including less than about 0.5%, also including less than about 0.1
%, and
also including zero percent, by weight of the identified ingredient.
(0033) The various embodiments of the nutritional emulsions may comprise,
consist
of, or consist essentially of any of the essential features or ingredients
described
herein, as well as any additional or optional features or ingredients
described herein
or otherwise useful in a nutritional emulsion.
(0034) Numerical ranges as used herein are intended to include every number
and
subset of numbers contained within that range, whether specifically disclosed
or not.
Further, these numerical ranges should be construed as providing support for a
claim
directed to any number or subset of numbers in that range. For example, a
disclosure of from 1 to 10 should be construed as supporting a range of from 2
to 8,
from 3 to 7, from 5 to 6, from 1 to 9, from 3.6 to 4.6, from 3.5 to 9.9, and
so forth.
Product Form
(0035) The nutritional emulsions are aqueous systems in the form of oil-in-
water,
water-in-oil, or complex emulsions, although most typically the emulsions are
oil-in-
water emulsions having a continuous aqueous phase and a discontinuous oil
phase.
Water content varies among the emulsions but most typically ranges from about
70%
to about 90%, more typically from about 75% to about 85%, by weight of the
emulsions.
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(0036) The nutritional emulsion have a drinkable viscosity at room temperature
and
or when chilled prior to consumption. The emulsions may therefore have a
viscosity
as measured at room temperature (20 C) of less than about 300 cps, typically
from
about 10 cps to about 160 cps, and more typically from about 20 cps to about
70 cps.
(0037) The nutritional emulsions 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 emulsion for use in individuals
afflicted with
specific diseases or conditions such as, for example, diabetes or other
abnormal
glucose tolerance conditions.
(0038) These nutritional emulsions may also have a product density of greater
than
about 1.055 g/mL, including from 1.06 g/ml to 1.08 g/ml.
(0039) The nutritional emulsions may be retort or aseptically packaged in a
suitable
glass, plastic, metal, or other container, although it has been found
advantageous to
formulate with a plastic or other non-metal and non-glass container or package
having a plastic interior surface in contact with the emulsions, which plastic
interior
surface represents a majority of the interior surface area of the container or
package.
These packages are particularly useful when used with the emulsions and
subjected
to retort sterilization and packaging.
Diacvlolvicerol
(0040) The nutritional emulsions may comprise a diacylglycerol oil as defined
herein.
Such diacylglycerol oil concentrations range from at least about 1 %,
including from
about 1.75% to about 4%, and also including from about 1.8% to about 3%, and
also
including from about 1.9% to about 2.7%, by weight of the emulsion.
(0041) The term diacylglycerol oil" is an art recognized term and as used
herein
refers to a processed oil comprising from about 60% to 100%, including from
about
70% to about 85%, by weight of a diglyceride. The diacylglycerol oil may
represent
from about 10% to 100%, including from about 40% to about 80%, and also
including
from about 50% to about 70%, by weight of the fat in the emulsion
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(0042) Diacylglycerol oils are well known in the nutrition arts and typically
comprise a
blend of monoglycerides, diglycerides, and triglycerides, wherein the
diglycerides
represent a majority of the glycerol esters therein. These oils are typically
processed
vegetable oils such as soy and or cocoa oils comprising about 80% by weight of
diglycerides and about 20% by weight of other glycerol esters, i.e.,
triglycerides and
monoglycerides. The diglycerides may comprise C16-24 fatty acid esters,
including
C16-20 fatty acid esters, most typically esters of oleic, linoleic and or
linolenic acid.
A non limiting example of a diacylglycerol oil suitable for use herein is
Enova Oil,
available from Kao Health and Nutrition, Itasca, Illinois, USA.
(0043) Although the nutritional emulsions may comprise any of a variety of
natural
oils, most or all of which comprise a minor amount of diacylglycerol esters
(diglycendes), these natural oils do not contain sufficient relative amounts
of
diglycerides to represent the diacylglyerol oil component of the emulsions
herein.
(0044) The nutritional emulsions may further comprise lecithin in combination
with
the diacylglycerol oil. Lecithin concentrations may range from at least about
0.1%,
including from about 0.16% to about 0.5%, by weight of the emulsion.
(0045) The diacylglycerol component may be replaced and the desired physical
stability of the formulations described herein maintained with an oil blend
comprising
from 30 to 50%, high oleic safflower oil, from 20 to 40% Canola oil, from 15
to 35%
soy oil, and 1 to 10% lecithin, all by weight of the oil blend, including a
blend of
4013012515 of these oils, respectively. The replacement blend may be used at
the
same concentrations by weight of the finished nutritional emulsion described
herein
for the diacylglycerol component.
Fiber
(0046) The nutrition emulsions comprise fiber at levels representing at least
about
1.5%, including from about 2.0% to about 9%, and also including from about 2.1
% to
about 6%, and also including from about 2.2% to about 4.3%, by weight of the
emulsions. The fiber may represent from about 10% to 100%, including from
about
12% to about 40%, and also including from about 15% to about 25%, by weight of
the total carbohydrates in the emulsions-
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(0047) The fiber as used herein refers generally to those components of a
nutritional
product that are not absorbed by the body or not otherwise broken down by
enzymes
in the human digestive tract to small molecules and then absorbed. The fiber
may
include any known fiber or fiber source suitable for oral administration in a
nutritional
product, including fiber or sources thereof that are soluble and or insoluble,
fermentable or non fermentable, or combinations or variations thereof.
(0048) Fiber for use herein may be divided into soluble and insoluble types
based on
the fiber's capacity to be solubilized in a buffer solution at a defined pH.
Fiber
sources differ in the amount of soluble and insoluble fiber they contain. As
used
herein, unless otherwise specified, soluble and insoluble fiber designations,
and
concentrations or amounts thereof and including total fiber concentrations are
determined using Association of Official Analytical Chemists A(OAC) Method
991.43.
(0049) Non limiting examples of soluble dietary fiber or fiber sources for use
herein
include gum arabic, sodium carboxymethylcellulose, guar gum, citrus pectin,
low and
high methoxy pectin, oat and barley glucans, carrageenan and psyllium.
Numerous
commercial sources of soluble dietary fibers are available. For example, gum
arabic,
hydrolyzed carboxymethylcellulose, guar gum, pectin and the low and high
methoxy
pectins are available from TIC Gums, Inc. of Belcamp, Maryland. The oat and
barley
glucans are available from Mountain Lake Specialty Ingredients, Inc. of Omaha,
Nebraska. Psyllium is available from the Meer Corporation of North Bergen, New
Jersey while the carrageenan is available from FMC Corporation of
Philadelphia,
Pennsylvania.
(0050) Non limiting examples of insoluble dietary fiber or fiber sources for
use herein
include oat hull fiber, pea hull fiber, soy hull fiber, soy cotyledon fiber,
sugar beet
fiber, cellulose and corn bran. Numerous sources for the insoluble dietary
fibers are
also available. For example, the corn bran is available from Quaker Oats of
Chicago,
Illinois; oat hull fiber from Canadian Harvest of Cambridge, Minnesota; pea
hull fiber
from Woodstone Foods of Winnipeg, Canada; soy hull fiber and oat hull fiber
from
The Fibrad Group of LaVale, Maryland; soy cotyledon fiber from Protein
Technologies International of St. Louis, Missouri; sugar beet fiber from Delta
Fiber
Foods of Minneapolis, Minnesota and cellulose from the James River Corp. of
Saddle Brook, New Jersey.
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(0051) The fiber for use herein may also include fructooligosaccharides (FOS),
including those having a degree of polymerization of from 2 to 10, most
typically from
3-7, and or inulin, including inulin having a degree of polymerization of at
least 10,
including from about 20 to about 50, and or a glucooligosaccharides (GOS). The
FOS, GOS, and or inulin may represent from zero to about 50%, including from
about
5% to about 30%, including from about 10% to about 20%, by weight of the fiber
in
the nutritional emulsion. As used herein, the fiber content of FOS fiber may
be
determined in accordance with Association of Official Analytical Chemists
(AOAC)
Method 997.08 or otherwise assumed to be about 96% by weight of the FOS.
(0052) One commercial fiber source suitable for use herein is Fibersol- 2TM, a
soluble fiber source comprising about 37% by weight of dietary fiber, which is
available from ADM Company, Decatur, Illinois, USA.
(0053) The nutritional emulsions may also comprise a weight ratio of the fiber
to the
diacylglycerol oil of at least about 1.20:1, including from about 1.23:1 to
about 5:1,
and also including from about 1.24:1 to about 1.8:1.
Suuar
(0054) The nutritional emulsions may comprise relatively low sugar
concentrations
ranging from zero to about 2.1 %, including from about 0.5% to about 1.8%, and
also
including from about 0.9% to about 1.7%, by weight of the emulsion. As such,
the
emulsions may also have a high fiber to sugar ratio of greater than about 1:1,
including from about 20:1 to about 1:1, and also including from about 3:1 to
about
1.4:1.
(0055) In the present context, the term "sugar" refers to the total sum of
mono and
disaccharides in the emulsions.
(0056) The total carbohydrate to sugar ratio in the nutritional emulsions may
range
from at least about 5:1, including from about 5.5:1 to about 20:1, including
from about
6:1 to about 10:1, and also including from about 7:1 to about 9:1.
(0057) The nutritional emulsions may further comprise artificial sweeteners
such as
saccharin, aspartame, sucralose, neotame, acesUlfame potassium, or
combinations
thereof. The ratio of the artificial sweeteners to sugar may range from at
least about
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0.0060:1, including from about 0.0070:1 to about 0.0300:1, including from
about
0.0080:1 to about 0.0095:1.
(0058) The nutritional emulsions may also comprise glycerin as a sweetening
agent,
which may be used in combination with sugar (at low sugar concentrations
described
herein) and the artificial sweeteners in the artificial sweetener to sugar
ratios as
described herein.
Milk Protein Concentrate
(0059) The nutritional emulsions may comprise milk protein concentrate (MPC),
which may represent some or all of the protein in the emulsions. The emulsions
may
comprise MPC at concentrations of at least about 0.5%, including from about 1
% to
about 9%, and also including from about 2% to about 6%, by weight of the
emulsions.
(0060) Suitable milk protein concentrates for use herein include any such
concentrate that is suitable for use in an oral nutritional product. In this
context, the
term "milk protein concentrate" refers to bovine milk products having a
protein
content that typically represents from about 40% to about 88%, including from
about
60% to about 80%, and also including from about 65% to about 75%, by weight of
the milk product. Milk protein concentrates also typically comprise minor
amounts of
lactose and milk fat.
Glycerin
(0061) The nutritional emulsions may comprise glycerin, concentrations of
which
may represent from about 2.0% to about 6.0%, including from about 2.1 % to
about
4.0%, and also including from about 2.2% to about 3.0%, by weight of the
nutritional
emulsion.
(0062) Suitable glycerin sources include any glycerin product suitable for use
in an
oral nutritional product.
Fructose and Leucrose
(0063) The nutritional emulsions may comprise a combination of fructose and
leucrose, wherein the leucrose represents at least about 0.15% by weight of
the
nutritional emulsion, including from about 0.15% to about 1.0%, and also
including
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from about 0.30% to about 0.40%, by weight of the nutritional emulsion.,
wherein the
weight ratio of fructose to leucrose is at least about 1.5:1, including from
about 2:1
to about 20:1, and also including from about 2.8:1 to about 8:1.
(0064) The fructose and leucrose may be added individually or in combination
to the
nutritional emulsion. A commercial source of one such combination is available
from
Cargill Sweetener Solutions, Minneapolis, Minnesota, USA, as Cargill's
Sucromalt
SM05 syrup which includes on a dry weight basis about 37% fructose, 13%
leucrose,
48% saccharides and 2% other disaccharides.
Chromium Picolinate
(0065) The nutritional emulsions may comprise chromium picolinate at
concentrations suitable for oral administration. Such concentrations may range
from
at least about 0.002%, including from about 0.0020% to about 0.00010%, and
also
including from about 0.0010% to about 0.00040%, and also including from about
0.00090% to about 0.00060%, by weight of the emulsion.
(0066) Chromium picolinate may be formulated into the nutritional emulsions
described herein to assist in blood glucose control when used in combination
with the
other nutrients described herein.
Macronutrients
(0067) The nutritional emulsions comprise fat, protein, and carbohydrate.
Generally,
any source of fat, protein, and carbohydrate that is known or otherwise
suitable for
use in an oral nutritional product is also suitable for use herein, provided
that such
nutrients are also compatible with the other selected ingredients in the
formulation.
(0068) Although total concentrations or amounts of the fat, protein, and
carbohydrates may vary depending upon the nutritional needs of the intended
user,
such concentrations or amounts most typically fall within one of the following
embodied ranges, inclusive of other essential fat, protein, and or
carbohydrate
ingredients as described herein.
(0069) 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%,
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by weight of the nutritional emulsion; fat concentrations most typically range
from
about 2% to about 30%, including from about 3% to about 15%, and also
including
from about 5% 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 emulsion.
(0070) Non-limiting examples of suitable fats or sources thereof for use in
the
nutritional emulsions described herein include diacylglycerol oil as described
herein,
lecithin as described herein, 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.
(0071) Non-limiting examples of suitable carbohydrates or sources thereof for
use in
the nutritional emulsions described herein may include maltodextrin,
hydrolyzed or
modified starch or cornstarch, glucose polymers, corn syrup, corn syrup
solids, rice-
derived carbohydrates, glucose, fructose, lactose, high fructose corn syrup,
honey,
sugar alcohols (e.g., maltitol, erythritol, sorbitol), and combinations
thereof.
(0072) Non-limiting examples of suitable protein or sources thereof for use in
the
nutritional emulsions 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, caseinates, whole
cow's milk,
partially or completely defatted milk, soy protein isolates, soy protein
concentrates,
and so forth.
Optional Ingredients
(0073) The nutritional emulsion 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
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suitable for use in other nutritional products and may also be used in the
nutritional
emulsions 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.
(0074) Non-limiting examples of such optional ingredients include
preservatives,
antioxidants, emulsifying agents, buffers, pharmaceutical actives, additional
nutrients
as described herein, colorants, flavors, thickening agents and stabilizers
(e.g.,
carrageenan, avicel), sterols, phytosterols, turmeric, lubricants and so
forth.
(0075) The nutritional emulsions may further comprise vitamins or related
nutrients,
non-limiting 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.
(0076) The nutritional emulsion may further comprise minerals, non-limiting
examples of which include calcium, phosphorus, magnesium, iron, zinc,
manganese,
copper, sodium, potassium, molybdenum, chromium, selenium, chloride, and
combinations thereof.
Method of Manufacture
(0077) The nutritional emulsions may be manufactured by any conventional or
otherwise known method for making nutritional emulsions, most typically for
making
nutritional aqueous emulsions or milk based emulsions.
(0078) In one suitable conventional manufacturing process, two or more
separate
slurries are prepared, one of which is an aqueous slurry that is substantially
free of
fat. One or more additional slurries may include a protein in a fat/oil slurry
(e.g.,
protein, fat, emulsifier or surfactant, etc.) a protein in water slurry (e.g.,
protein in
water), and additional carbohydrate-mineral slurries. The multiple slurries
are
eventually combined together in a blend tank, subjected to ultra high
temperature
processing, homogenized, infused with added vitamins, minerals, or other
optional
ingredients, and diluted with water as appropriate.
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(0079) The manufacturing processes may further include packaging the resulting
nutritional emulsion in a suitable container that may either be, for example,
metal,
glass or plastic, and may be re-closeable. The method may also further include
exposing the packaged nutritional emulsion to retort sterilization to produce
a retort
packaged nutritional emulsion. Retort sterilization is a process step well
known to
one of ordinary skill in the formulation art, which typically involves high
temperature
treatment of a packaged liquid nutritional. The nutritional emulsion may also
be
aseptically packaged rather than retort sterilized.
(0080) The manufacturing processes for the nutritional emulsions are not
critical and
may be carried out in other ways than those set forth herein without departing
from
the spirit and scope of the present invention. The present embodiments are,
therefore, to be considered in all respects illustrative and not restrictive
and that all
changes and equivalents also come within the description of the present
invention.
(0081) Surprisingly, it has now been discovered the certain combinations of
components as disclosed and described herein may provide unexpected benefits
to
the high fiber nutritional emulsions. One or more of these unexpected benefits
may
be the result of a synergistic combination of two or more the components
described
herein. One or more of the combination of specific components described herein
may impart improved and unexpected characteristics to the high fiber emulsions
as
compared to conventional nutritional emulsions. In one embodiment, the
combination
of components in the high fiber emulsion may provide an improved glycemic
response in combination with a higher caloric content. In another embodiment,
the
combination of components in the high fiber emulsion may provide a highly
stable
high fiber emulsion that can be manufactured using more desirable, low-
temperature
processing, despite the high fiber content. In yet another embodiment, the
components of the high fiber emulsion may provide improved hedonics and
improved
gastrointestinal tolerance while providing high fiber, higher calories, and an
improved
blunted glycemic response.
(0082) Novel component blends utilized in the high fiber emulsions described
herein
may include any combination of any two, three, four, five or more of the
following
components, which may each individually or in combination (even synergistic
combination) contribute to the surprising benefits of the high fiber emulsions
described above: diacylglycerol oil, milk protein concentrate, sucromalt,
fiber,
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fructooligosaccharides, insoluble fiber, turmeric, glycerin, chromium
picolinate,
monounsaturated fatty acids having from 16-24 carbon atoms, leucrose, and
fructose. That is, any one of these components may be combined with any one or
more of the other components and may provide surprising benefits to the
resulting
high fiber emulsion.
EXAMPLES
(0083) The following examples illustrate specific embodiments and or features
of the
nutritional emulsions. The examples are given solely for the purpose of
illustration
and are not to be construed as limitations, as many variations thereof are
possible
without departing from the spirit and scope of the invention.
Example 14
(0084) These examples illustrate nutritional embodiments of the present
disclosure,
the ingredients of which are listed in the following table. All ingredient
amounts are
listed as kg per 1000 kg batch of product, unless otherwise specified. The
formulations are shelf stable, aqueous emulsions.
(0085) The formulations are prepared by conventional methods by combining the
appropriate ingredients into a separate carbohydrate-mineral slurry, a
separate
protein-in-water slurry, and a separate protein-in-oil slurry. 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 an
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 (--1.0628 g/mL). The resulting
nutritional emulsion is then sterilized and retort packaged into 8 oz plastic
bottles.
The selected bottles have narrow neck portions extending from 1-5 an from the
broader package body.
(0086) The exemplified compositions when packaged provide desirable features,
including one or more desirable features such as physical or chemical or
emulsion
stability, desirable hedonics, favorable rheology or viscoelastic properties,
and
product performance as defined herein. The formulations are physically stable
when
16
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packaged and stored for up to 18 months at 20 C and provide a blunted glycemic
response with minimal or no gastrointestinal intolerance, especially when used
in
diabetics or other individuals in whom such a blunted glycemic response would
be
beneficial.
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Ingredient Example 1 Example 2 Example 3 Example 4
Water QS QS QS QS
Fibersol-2TM' 52.6 68.6 137.2 205.7
Milk protein concentrate 38.5 38.5 38.5 38.5
Sucroma 36.4 36.4 36.4 36.4
Glycerine 22.0 22.0 22.0 22.0
Enova a Oil 18.6 18.6 18.6 18.6
Soy protein concentrate 18 18 18 18
MALTRIN M 100 10.6 10.6 10.6 10.6
Canola oil 7.8 7.8 7.8 7.8
Fructooligosacchande 5.0 6.5 13.0 19.6
Plant sterol esters 3.2 3.2 3.2 3.2
High Oleic Safflower Oil 3.1 3.1 3.1 3.1
Magnesium Phosphate 2.4 2.4 2.4 2.4
Flavor 3.3 3.3 3.3 3.3
Potassium citrate 2.0 2.0 2.0 2.0
Sodium citrate 2.0 2.0 2.0 2.0
Soy lecithin (5%OB) in 1 6 1.6 1.6 1.6
Soybean oil
Potassium Chloride 0.900 0.900 0.900 0.900
Calcium Phosphate 0.670 0.670 0.670 0.670
Choline Chloride 0.6515 0.6515 0.6515 0.6515
Sodium Chloride 0.650 0.650 0.650 0.650
Ascorbic Acid 0.5841 0.5841 0.5841 0.5841
Magnesium Chloride 0.5000 0.5000 0.5000 0.5000
Viscarin SA-359 0.4500 0.4500 0.4500 0.4500
45% KOH Solution 0.4181 0.4181 0.4181 0.4181
UTM/TM/WSV 0.2717 0.2717 0.2717 0.2717
Liquid Sucrolose (25%) 0.1600 0.1600 0.1600 0.1600
Acesulfame Potassium 0.0940 0.0940 0.0940 0.0940
Turmeric concentrate 0.0750 0.0750 0.0750 0.0750
Vitamin DEK premix 0.0651 0.0651 0.0651 0.0651
Viit. A Palm. (54% oil) 0.0091 0.0091 0.0091 0.0091
Potassium iodide 220 mg 220 mg 220 mg 220 mg
Vitamin B12 16mg 16 mg 16 mg 16 mg
(Total Fiber) 2.3% 3.0% 6.0% 9.0%
1. Soluble fiber source; 37% by weight of dietary fiber; ADM Company, Decatur,
Illinois USA
2. Sucromalt SM05 Syrup with 37% fructose, 13% leucrose (dry wt); Cargill,
Minneapolis, MN
USA
3. Diacylgiycerol oil; Kao Health and Nutrition, Itasca, IL USA
4. Mattodextrin DE 9-12; Grain Processing Corporation. Muscatine Iowa
5. Carrageenan: FMC Biopolymer. Philadelphia, Pennsylvania, USA
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Examples 5-8
(0087) These examples illustrate nutritional embodiments of the present
disclosure,
the ingredients of which are listed in the following table. All ingredient
amounts are
listed as kg per 1000 kg batch of product, unless otherwise specified. The
formulations are shelf stable, aqueous emulsions that are prepared and
packaged in
accordance with the process described in Examples 1-4.
Ingredient Example 5 Example 6 Example 7 Example 8
Water QS QS QS QS
Fibersol 2 52.6 52.6 52.6 52.6
Milk protein concentrate 38.5 38.5 38.5 38.5
Sucromalt 36.4 36.4 36.4 36.4
Glycerin 22.0 22.0 22.0 22.0
EnovaTm Oil 20.0 25.0 30.0 40.0
Soy protein concentrate 18 18 18 18
Maltrin M 100 10.6 10.6 10.6 10.6
Canola oil 7.8 7.8 7.8 7.8
Fructooligosaccharide 5.0 5.0 5.0 5.0
Plant sterol esters 3.2 3.2 3.2 3.2
High Oleic Safflower Oil 3.1 3.1 3.1 3.1
Magnesium Phosphate 2.4 2.4 2.4 2.4
Flavor 3.3 3.3 3.3 3.3
Potassium citrate 2.0 2.0 2.0 2.0
Sodium citrate 2.0 2.0 2.0 2.0
Soy lecithin (5%OB) in 1 6 1.6 1.6 1.6
Soybean oil
Potassium Chloride 0.900 0.900 0.900 0.900
Calcium Phosphate 0.670 0.670 0.670 0.670
Choline Chloride 0.6515 0.6515 0.6515 0.6515
Sodium Chloride 0.650 0.650 0.650 0.650
Ascorbic Acid 0.5841 0.5841 0.5841 0.5841
Magnesium Chloride 0.5000 0.5000 0.5000 0.5000
Viscarin SA 359 0.4500 0.4500 0.4500 0.4500
45% KOH Solution 0.4181 0.4181 0.4181 0.4181
UTMlfMIWSV 0.2717 0.2717 0.2717 0.2717
Liquid Sucralose (25%) 0.1600 0.1600 0.1600 0.1600
Acesulfame Potassium 0.0940 0.0940 0.0940 0.0940
Turmeric concentrate 0.0750 0.0750 0.0750 0.0750
Vitamin DEK premix 0.0651 0.0651 0.0651 0.0651
Vit. A Palm. (54% oil) 0.0091 0.0091 0.0091 0.0091
Potassium iodide 220 mg 220 mg 220 mg 220 mg
Vitamin B12 16mg 16 mg 16 mg 16 mg
(Total Fiber) 2.3% 2.3% 2.3% 2.3%
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Examples 9-12
(0088) These examples illustrate nutritional embodiments of the present
disclosure,
the ingredients of which are listed in the following table. All ingredient
amounts are
listed as kg per 1000 kg batch of product, unless otherwise specified. The
formulations are shelf stable, aqueous emulsions that are prepared and
packaged in
accordance with the process described in Examples 1-4.
Ingredient Example 9 Example 10 Example 11 Example 12
Water QS QS QS QS
Fibersol 2 52.6 52.6 52.6 52.6
Milk protein concentrate 10 30 60 90
Sucromalt 36.4 36.4 36.4 36.4
Glycerin 22.0 22.0 22.0 22.0
EnovaTM Oil 18.6 18.6 18.6 18.6
Soy protein concentrate 18 18 18 18
Maltrin M 100 10.6 10.6 10.6 10.6
Canola oil 7.8 7.8 7.8 7.8
Fructooligosacchadde 5.0 5.0 5.0 5.0
Plant sterol esters 3.2 3.2 3.2 3.2
High Oleic Safflower Oil 3.1 3.1 3.1 3.1
Magnesium Phosphate 2.4 2.4 2.4 2.4
Flavor 3.3 3.3 3.3 3.3
Potassium citrate 2.0 2.0 2.0 2.0
Sodium citrate 2.0 2.0 2.0 2.0
Soy lecithin (5%OB) in 1.6 1.6 1.6 1.6
Soybean oil
Potassium Chloride 0.900 0.900 0.900 0.900
Calcium Phosphate 0.670 0.670 0.670 0.670
Choline Chloride 0.6515 0.6515 0.6515 0.6515
Sodium Chloride 0.650 0.650 0.650 0.650
Ascorbic Acid 0.5841 0.5841 0.5841 0.5841
Magnesium Chloride 0.5000 0.5000 0.5000 0.5000
Viscarin SA-359 0.4500 0.4500 0.4500 0.4500
45% KOH Solution 0.4181 0.4181 0.4181 0.4181
IJTMITMIWSV 0.2717 0.2717 0.2717 0.2717
Liquid Sucralose (25%) 0.1600 0.1600 0.1600 0.1600
Acesulfame Potassium 0.0940 0.0940 0.0940 0.0940
Turmeric concentrate 0.0750 0.0750 0.0750 0.0750
Vitamin DEK premix 0.0651 0.0651 0.0651 0.0651
Vit A Palm. (54% oil) 0.0091 0.0091 0.0091 0.0091
Potassium iodide 220 mg 220 mg 220 mg 220 mg
Vitamin B12 16mg 16 mg 16 mg 16 mg
(Total Fiber) 2.3% 2.3 2.3 2.3
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Examples 13-16
(0089) These examples illustrate nutritional embodiments of the present
disclosure,
the ingredients of which are listed in the following table. All ingredient
amounts are
listed as kg per 1000 kg batch of product, unless otherwise specified. The
formulations are shelf stable, aqueous emulsions that are prepared and
packaged in
accordance with the process described in Examples 1-4.
Ingredient Example 13 Example 14 Example 15 Example 16
Water QS QS QS QS
Fibersol 2 52.6 52.6 52.6 52.6
Milk protein concentrate 38.5 38.5 38.5 38.5
Sucromalt 36.4 36.4 36.4 36.4
Glycerin 25.0 30.0 35.0 40.0
EnovaTm Oil 18.6 18.6 18.6 18.6
Soy protein concentrate 18 18 18 18
Maltrin M 100 10.6 10.6 10.6 10.6
Canola oil 7.8 7.8 7.8 7.8
Fructooligosaccharide 5.0 5.0 5.0 5.0
Plant sterol esters 3.2 3.2 3.2 3.2
High Oleic Safflower Oil 3.1 3.1 3.1 3.1
Magnesium Phosphate 2.4 2.4 2.4 2.4
Flavor 3.3 3.3 3.3 3.3
Potassium citrate 2.0 2.0 2.0 2.0
Sodium citrate 2.0 2.0 2.0 2.0
Soy lecithin (5%OB) in 1.6 1.6 1.6 1.6
Soybean oil
Potassium Chloride 0.900 0.900 0.900 0.900
Calcium Phosphate 0.670 0.670 0.670 0.670
Choline Chloride 0.6515 0.6515 0.6515 0.6515
Sodium Chloride 0.650 0.650 0.650 0.650
Ascorbic Acid 0.5841 0.5841 0.5841 0.5841
Magnesium Chloride 0.5000 0.5000 0.5000 0.5000
Viscarin SA-359 0.4500 0.4500 0.4500 0.4500
45% KOH Solution 0.4181 0.4181 0.4181 0.4181
UTM/TMNVSV 0.2717 0.2717 0.2717 0.2717
Liquid Sucralose (25%) 0.1600 0.1600 0.1600 0.1600
Acesulfame Potassium 0.0940 0.0940 0.0940 0.0940
Turmeric concentrate 0.0750 0.0750 0.0750 0.0750
Vitamin DEK premix 0.0651 0.0651 0.0651
V=it. A Palm. (54% oil) 0.0091 0.0091 0.0091 0.0091
Potassium iodide 220 mg 220 mg 220 mg 220 mg
Vitamin B12 16mg 16 mg 16 mg 16 mg
Total Fiber 2.3% 2.3 2.3 2.3
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Examples 17-20
(0090) These examples illustrate nutritional embodiments of the present
disclosure,
the ingredients of which are listed in the following table. All ingredient
amounts are
listed as kg per 1000 kg batch of product, unless otherwise specified. The
formulations are shelf stable, aqueous emulsions that are prepared and
packaged in
accordance with the process described in Examples 1-4.
Ingredient Example 17 Exam le 18 Example 19 Example 20
Water QS QS QS QS
Fibersol 2 52.6 52.6 52.6 52.6
Milk protein concentrate 38.5 38.5 38.5 38.5
Sucromalt 30 35 40 50
Glycerin 22.0 22.0 22.0 22.0
Enova'm Oil 18.6 18.6 18.6 18.6
Soy protein concentrate 18 18 18 18
Maltrin M 100 10.6 10.6 10.6 10.6
Canola oil 7.8 7.8 7.8 7.8
Fructooligosaccharide 5.0 5.0 5.0 5.0
Plant sterol esters 3.2 3.2 3.2 3.2
High Oleic Safflower Oil 3.1 3.1 3.1 3.1
Magnesium Phosphate 2.4 2.4 2.4 2.4
Flavor 3.3 3.3 3.3 3.3
Potassium citrate 2.0 2.0 2.0 2.0
Sodium citrate 2.0 2.0 2.0 2.0
Soy lecithin (5%OB) in 1 6 1.6 1.6 1.6
Soybean oil
Potassium Chloride 0.900 0.900 0.900 0.900
Calcium Phosphate 0.670 0.670 0.670 0.670
Choline Chloride 0.65 5 0.6515 0.6515 0.6515
Sodium Chloride 0.650 0.650 0.650 0.650
Ascorbic Acid 0.5841 0.5841 0.5841 0.5841
Magnesium Chloride 0.5000 0.5000 0.5000 0.5000
Viscarin SA-359 0.4500 0.4500 0.4500 0.4500
45% KOH Solution 0.4181 0.4181 0.4181 0.4181
UTM/TM!WSV 0.2717 0.2717 0.2717 0.2717
Liquid Sucralose (25%) 0.1600 0.1600 0.1600 0.1600
Acesulfame Potassium 0.0940 0.0940 0.0940 0.0940
Turmeric concentrate 0.0750 0.0750 0.0750 0.0750
Vitamin DEK premix 0.0651 0.0651 0.0651 0.0651
Vit A Palm. (54% oil) 0.0091 0.0091 0.0091 0.0091
Potassium iodide 220 mg 220 mg 220 mg 220 mg
Vitamin B12 16mg 16 mg 16 mg 16 mg
Total Fiber 2.3% 2.3% 2.3% 2.3%
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Study I
(0091) In this study, an embodiment of the present invention (Al) is evaluated
for
insulin sensitivity benefits relative to separate controls (A2 and A3)_ Al is
a balanced
nutritional formulation of the present invention and is compared to
formulations A2
(Carb-Chromium) and A3 (carb-protein-chromium) which contain only selected
components of Al and do not contain the requisite balanced formulation
required of
the present invention-
Ingredient Formula Al Formula A2 Formula A3
g/100 g diet g/100 g diet g/100 g diet
Protein (milk protein conc., soy 5.5 - 5.4
protein conc.)
Carbohydrate blend (sucromalt, 12.7 11.1 11.1
glycerol, Fibersol II) with total
fiber of - 2.6-5.2
Chromium picolinate 0.7 mg/1 00 g 0.7 m g/100 0.7 m g/100 g
DAG Oil 0.197
Canola oil 0.82
Ascorbic acid 0.028
Maltrin M100 1.059
Mg Chloride 0.075
Sodium Chloride 0.05
Potassium chloride 0.09
Potassium citrate 0.2
Potassium hydroxide 45% 0.041
Sodium citrate 0.2
Choline chloride 0.065
Tricalcium phosphate 0.1
Mg Phosphate dibasic 0.25
High oleic safflower oil 0.329
Carrageenan Viscarin SA 359 0.04
Vitamin D, E. K 0.006
FOS powder 0.5
UTMITM/WSV Premix 0.027
Fluid Lecithin 0.164
Caloric density 0.837 0.3121 0.5
(0092) In preparation for this example, 32 male Zucker faffa rats (9 wks, 5
days old),
0.423 kg body weights at the start of the study) are sorted into three groups
(n=1 0-
11) matched for body weight. The rats are given ad libitum access to a semi-
purified
pelleted diet (Study Diet") meant to mimic a poor-quality Standard American
Diet, in
that it is rich in saturated fat and high glycemic carbohydrates. In addition,
the rats
are given access to one of the three liquid supplements Al, A2, or A3. Al is a
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balanced nutritional embodiment of the present invention. A2 is a solution
comprising the functional carbohydrates and chromium picolinate of Al. A3 is a
solution comprising the functional carbohydrates, chromium and proteins of Al.
Both
of the A2 and A3 solutions are prepared so the rats consume the levels of
functional
carbohydrates (Fibersol, Sucromalt and Glycerol) (2.83kcals/gram) and proteins
(milk
protein concentrate and soy protein concentrate) (3.46 kcals/gram) found in
the Al
formulation.
(0093) Overnight fasting blood samples are taken for assay of glucose, insulin
glycated hemoglobin after 0, 14, and 28 days of feeding the Study Diet with or
without supplementation. Insulin tolerance is measured just before rats are
given
study diets and after 28 days of feeding. To measure insulin tolerance,
overnight
fasted rats are injected with regular insulin (1 U/kg body wt; Humulin , Eli
Lilly
Company). Blood samples are obtained from the tip of the tail before and at
30, 60,
90, and 120 minutes after insulin injection. Food is returned at the end of
the test.
(0094) Supplement compositions do not affect fasting blood glucose
concentration
over the 28 day feeding period. Surprisingly, A3 and A2 increase plasma
insulin
compared to Al (see Fig. 1; p<0.01 on day 14 for A2 vs. Al). A3 significantly
worsens insulin sensitivity compared to Al (see Fig. 2). A2 supplementation
magnifies the increase in glycated hemoglobin 0.9% from Day 0 to Day 28
compared
to 0.2% for Al (Fig. 3).
(0095) Based on the above assessment, it is surprisingly found that voluntary
consumption of the presumed functional ingredients of the Al formulation
(Fibersol,
Sucromalt, glycerol, chromium picolinate, milk protein concentrate, and soy
protein
concentrate) worsens insulin sensitivity and metabolic control compared to
voluntary
consumption of the complete Al formula. Thus, the beneficial effect of the Al
formula cannot be explained by any individual component and must reside in the
complete balanced formulation as disclosed herein.
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Study II
(0096) A study is conducted in which an embodiment of the present invention is
evaluated for insulin sensitivity and glycated hemoglobin.
(0097) In preparation for the study, twenty male Zucker faffa rats (9 wks old,
0.36 kg
body weight at the start of the study) are sorted into two groups of 10
matched for
body weight. The rats are fed "Study Diet", a semi-purified pelleted diet
meant to
mimic a poor-quality Standard American Diet, in that it is rich in saturated
fat and
high glycemic carbohydrates, including sucrose and maltodextrin. The rats are
either
fed the Study Diet alone (No Supplement") or are supplemented with Formula Al
described earlier.
(0098) Overnight fasted blood samples are taken for assay of glucose, insulin
glycated hemoglobin after 0, 14, and 28 days of feeding Study Diet with or
without
supplementation. Insulin tolerance is measured just before rats are given
study diets
and after 14 days of feeding. Rats are fasted overnight 16 hr and a fasting
blood
sample is collected from the tip of the tail at zero time. Immediately
afterwards, rats
are injected with regular insulin (1 U/kg body wt; Humulin , Eli Lilly
Company).
Blood samples are obtained from the tip of the tail at 30, 60, 90, and 120
minutes
after insulin injection. Food is returned at the end of the test.
(0099) Supplementation with the Al formulation does not affect blood glucose
concentrations. Surprisingly, voluntary consumption of Al reduced plasma
insulin
concentration (see Fig. 4) and improved insulin tolerance (see Fig. 5).
Glycated
hemoglobin concentration increases by 2.1 % over the duration of the study
(Fig. 6),
but surprisingly, voluntary consumption of Viking 2 for only four weeks limits
the
increase to only 0.6%. The rats in these experiments are not forced to consume
Viking 2. They are merely given access to the formula in addition to their
highly
palatable diet rich in fat and sugar. Surprisingly, these pre-diabetic rats
voluntarily
consume enough of the Al formulation to improve their insulin sensitivity as
measured by plasma insulin concentration and insulin tolerance test. In
addition, it
is surprising that voluntary consumption of the Al formulation for only four
weeks can
sharply limit the rise in glycated hemoglobin induced by high fat, high
sucrose Study
Diet in these prediabetic rats.
2s
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Study III
(0100) A study is conducted in which an embodiment of the present invention is
evaluated for satiety effects.
(0101) In preparation for the study, forty male Zucker faffa rats (9 wks old,
0.36 kg
body weight at the start of the study) are sorted into four groups of 10. The
groups
are matched for body weight. The rats are fed one of two solid diets. The
first is a
control chow Harlan 2018 (Harlan-Teklad, Madison, WI) and the second is a
"Study
Diet' which is a semi-purified pelleted diet meant to mimic a poor-quality
Standard
American Diet, in that it is rich in saturated fat and high glycemic
carbohydrates,
including sucrose and maltodextrin. The rats are either fed the unsupplemented
solid
diets (either control chow or the Study Diet alone or those same solid diets
are
supplemented with Formula Al (liquid) described earlier.
(0102) Experimental diets are provided for 28 days. Solid pelleted diets are
fed by
giving the rats approximately 50 grams of food on top of wire cage lid and
weighing
what remained daily. Spillage is taken into account. Liquid diet (Al formula)
is fed
by attaching a bottle to the front of the cage- Consumption is measured by
weighing
the bottles. Old diet is discarded and clean bottles and fresh liquid and
solid diet are
provided da9ily. All rats are fed solid and liquid diets ad libitum.
(0103) As expected, the study diet increased food intake and body weight
compared
to control chow (p<0.05, see Fig 7). This shows that the high fat, high
sucrose study
diet is preferred compared to the regular chow diet, suggesting that the rats
found it
highly palatable. When offered access to the Al formulation, however, rats
voluntarily consumed about 1000 kcal over the course of the study.
Surprisingly, rats
chose to decrease consumption of the palatable, preferred study diet to
compensate
for the calories they consumed as Al formulation (p<0.05; see Fig. 8)_ This
suggests
that the Al formulation is surprisingly palatable and satiating, causing rats
to reduce
intake of a preferred solid diet.
26
