Abstract: The present disclosure is directed to a nutritional powder , a translucent reconstitutable beverage formed therefrom, and methods relating thereto. The nutritional powder and beverage are adapted to include the proper balance of proteins , lipids , carbohydrates, vitamins and minerals appropriate for a pregnant woman. The nutritional compositions further stem the glycemic response and improve glycemia and insulinemia during gestational and lactating periods for preventing or reduce the incidence of glucose intolerance later in life.
Field of the Invention
The present invention relates generally to a nutritional composition, and more specifically
a nutritional powder, a substantially translucent reconstitutable beverage, and various
methods relating thereto.
Description of the Background of the Invention
A variety of nutritional supplements are available today and typically contain a mixture of
proteins, carbohydrates, lipids, vitamins, and minerals tailored to the nutritional needs of
the intended user. The nutritional supplements are provided in various product forms
including ready-to-drink liquids, reconstitutable powders, capsules and pills, and the like.
Among the many nutritional supplements available today, supplements tailored to
pregnant women have become particularly well known and are commonly used to provide
specialized nutritional supplements that are beneficial for both the mother and the unborn
child.
Supplements are known to provide advantages to an embryo in utero. For example,
docosahexaenoic acid (DHA) is commonly found in breast milk and is well-known for its
health benefits. DHA is a long-chain omega-3 fatty acid that is necessary for brain and
eye development of both children and adults and is related to growth, learning ability, and
neurological and visual development in children. Humans synthesize only small
quantities of DHA so it is often desirable to obtain DHA from nutritional supplements.
Pregnant women face numerous obstacles in obtaining DHA and other critical nutrients in
a way that does not negatively impact their diet or lifestyle. There are very few nutritional
beverages available for pregnant women, and the beverages that have previously been
available have been limited by consistency and flavor. Nutritional beverages for pregnant
women typically have been provided in the form of a thick, shake-like product.
Therefore, forming a liquid product that includes an appropriate amount of protein,
carbohydrates, vitamins and minerals suitable for pregnant women has previously
required that the nutritional beverage be provided as a viscous, shake-type product.
Shake products are substantially opaque and have a viscosities typically greater than about
25 centipoise (cps). Translucency of shake products may be characterized using the
Agtron color scale (from 0-100) by a score of greater than about 30. More often, shake
products have a score of greater than 40 on the Agtron color scale. In comparison,
purified water may be characterized by a score of about 0 on the Agtron color scale.
Viscous shake products suffer from numerous drawbacks however. In particular,
pregnant women have heightened taste sensory during pregnancy so the chalky taste and
appearance of shake products may be distasteful or unpleasant. Further, the shake
products are typically lower in protein, higher in fat, contain an undesirable amount of
calories, and are generally displeasing because of their thick appearance. Further, shakes
are limited in the types of flavoring that can be employed, which limits the variety of
flavors available to a pregnant woman. Still further, shake products are displeasing and
inconvenient to drink in warmer climates. Finally, many nutritional supplements that are
available for pregnant women are milk-based, which is a problem for women who suffer
with lactose intolerance.
In contrast, reconstitutable powders have become popular to try to overcome the
aforementioned drawbacks of shake products. In particular, powder products are formed
using methods known in the art and are adapted to be mixed with an aqueous liquid such
as water prior to consumption to form a nutritional beverage. However, reconstitutable
powders known in the art suffer from numerous drawbacks as well. For example, clarity
issues with the nutritional beverage product have previously prevented powder
manufacturers from being able to provide sufficient amounts of protein, carbohydrates,
vitamins, and minerals that pregnant women need. Thus, some powder manufacturers of
the prior art sacrifice quantity and include an insufficient amount of proteins, lipids, and
nutrients in the reconstitutable powder products to form a substantially translucent product
that pregnant women find appealing. There is a correlation between the quantity and
types of components in the nutritional supplement, and the visual appearance of the
nutritional supplement. In particular, the higher the level of protein, DHA, nutrients and
other sources in the nutritional supplement, the more opaque, cloudy, and viscous the
supplement.
A further obstacle pregnant women face is gestational diabetes, which is defined as any
degree of glucose intolerance with onset or recognition during pregnancy. According to
the World Health Organization, over 346 million people worldwide suffer from diabetes.
Diabetes can be caused by resistance to insulin (a hormone produced to control blood
sugar), too little insulin, or both. Carbohydrates contain carbon, oxygen, and hydrogen
and are responsible for many processes in the human body. Carbohydrates are contained
in many foods and beverages, the consumption of which directly impact blood glucose
levels. In particular, carbohydrates make blood glucose levels rise after consumption.
The prevalence of obesity and glucose intolerance in adolescents and adults has increased
rapidly over the past 20 years in the United States and globally and continues to rise.
Obesity is classically defined based on the percentage of body fat or, more recently, the
body mass index or BMI. The BMI is defined as the ratio of weight in kilograms divided
by the height in meters, squared. As obesity becomes more prevalent in all age groups, it
is inevitable that the number of women giving birth who are also overweight and/or
diabetic will also increase. It is known that overweight and obese women who become
pregnant have a greater risk of developing gestational diabetes. Maternal hyperglycemia
may lead to infants with increased body size and fat mass and such infants are themselves
prone to develop obesity and diabetes later in life, including during adolescence and
adulthood. Additionally, research has suggested that obese women who themselves have
normal glucose tolerance give birth to infants with a higher fat mass than those born to
women who are not obese.
It would therefore be desirable to provide nutritional compositions and methods that could
reduce the incidence or risk of multiple diseases or conditions, such as obesity, glucose
intolerance, and related co-morbidities associated to metabolic syndrome (cardiovascular
disease and hypertension). It would be further beneficial is such compositions were
provided in a form that were appealing to pregnant women. Namely, it would be
beneficial if the nutritional compositions were provided in a substantially translucent,
substantially non-viscous form in flavors that are appealing to pregnant women.
The nutritional compositions and associated methods provided herein are specifically
contemplated for use by pregnant women. It would therefore be desirable to formulate a
reconstitutable nutritional powder and associated beverage that includes the proper
balance of proteins, lipids, carbohydrates, vitamins and minerals appropriate for a
pregnant woman. It is further desirable to provide a nutritional composition in the form of
a powder adapted to be reconstituted, which forms a substantially transparent non-viscous
beverage that is refreshing. The compositions further stem the glycemic response and
improve glycemia and insulinemia during gestational and lactating periods for preventing
or reducing the incidence of glucose intolerance later in life. The present disclosure is
further directed to methods of preparing the nutritional compositions described herein.
SUMMARY OF THE INVENTION
In one embodiment of the invention, a nutritional powder comprises a protein source in an
amount between about 2 grams/ 100 kcal to about 15 grams/ 100 kcal of the nutritional
powder. The nutritional powder further comprises a carbohydrate system in an amount
between about 12 grams/ 100 kcal to about 20 grams/ 100 kcal of the nutritional powder.
The carbohydrate system is provided as a carbohydrate blend that includes from about 60%
to about 70% by weight slow rate of digestion simple carbohydrate, from about 6%> to
about 10% by weight complex carbohydrate, from about 5% to about 20%> by weight
nonabsorbent carbohydrate, and from about 2% to about 15% by weight indigestible
carbohydrate. A lipid source is included in an amount between about 0.2 grams/100 kcal
to about 0.8 grams/100 kcal of the nutritional powder. The lipid source further includes
about 50 milligrams/ 100 kcal to about 100 milligrams/ 100 kcal of docosahexaenoic acid
(DHA).
In a different embodiment of the invention, a translucent nutritional beverage comprises a
protein source in an amount between about 6 grams/100 kcal to about 10 grams/100 kcal
of the beverage and a carbohydrate system in an amount between about 12 grams/100 kcal
to about 20 grams/100 kcal of the beverage. The carbohydrate system is provided as a
carbohydrate blend that includes from about 60%> to about 70%> by weight slow rate of
digestion simple carbohydrate, from about 6%> to about 10%> by weight complex
carbohydrate, from about 5% to about 20% by weight nonabsorbent carbohydrate, and
from about 2% to about 15% by weight indigestible carbohydrate. The translucent
nutritional beverage further includes a lipid source in an amount between about 0.2
grams/100 kcal to about 0.8 grams/100 kcal of the beverage.
In another embodiment of the invention, a method of reconstituting a powder to form a
substantially translucent nutritional beverage comprises the step of dissolving a nutritional
powder in an aqueous liquid. The powder includes a protein source in an amount between
about 6 grams/100 kcal to about 10 grams/100 kcal of the nutritional powder, a
carbohydrate source in an amount between about 12 grams/100 kcal to about 20
grams/100 kcal of the nutritional powder, and a lipid component in an amount between
about 0.2 grams/100 kcal to about 0.8 grams/100 kcal of the nutritional powder. The
translucent nutritional beverage that is yielded has between about 423.3 to about 846.6
total kcal/kg (about 12 to about 24 kcal/ounce).
These and other aspects of the invention will become apparent in light of the following
detailed description.
BRIEF DESCRIPTION OF THE DRAWING
FIG. 1 illustrates the clumping propensity of a control nutritional formula having
hygroscopic components in comparison to the non-clumping nutritional formula of the
present disclosure that utilizes at least one non-hygroscopic ingredient.
DETAILED DESCRIPTION
The term "adult" as used herein refers to adults and children about 1 years and older.
The term "nutritional powder" as used herein, unless otherwise specified, refers to a
powdered nutritional composition that is designed for pregnant adults, obese adults, or
combinations thereof, that contains sufficient nutrients such as proteins, carbohydrates,
lipids, vitamins, and minerals to serve as a supplement, primary, or sole source of
nutrition.
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 components 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.
Numerical ranges as used herein are intended to include every number and subset of
numbers 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.
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.
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.
The nutritional powders and corresponding manufacturing methods of the present
disclosure can comprise, consist of, or consist essentially of the essential elements and
limitations of the disclosure as described herein, as well as any additional or optional
components, sources, or limitations described herein or otherwise useful in nutritional
powdered applications.
GENERAL
The nutritional powder of the present disclosure includes at least one protein source, at
least one lipid source such as DHA, at least one carbohydrate, vitamins, minerals, and
optionally includes additives such as flavoring and stabilizers. The nutritional powder is
adapted to be reconstituted using an aqueous liquid. The quantities of the individual
sources are selected to provide sufficient amounts of nutrients to a pregnant woman as
well as providing preferred characteristics of translucency, pH, viscosity, and cake
strength, as discussed herein. The amounts are further selected to assist in controlling
post-consumption glucose levels.
PROTEIN SOURCE
The nutritional powder preferably includes at least one protein source. The protein source
comprises at least one protein and optionally includes a mixture of protein sources.
Proteins useful in the powder described herein include milk, soy, rice, meat, vegetable,
egg, gelatin, and fish. Suitable proteins include, but are not limited to, soy based, milk
based, casein protein, whey protein, rice protein, vegetable protein (i.e., potato protein,
pea protein, canola protein) and mixtures thereof. The protein source may be provided in
concentrate form, hydrolysate form, or isolate form, however the isolate form is
particularly preferred for the reasons discussed herein.
The protein source of the nutritional powder preferably comprises whey protein. Whey is
a natural dairy protein that stems from the cheese making process, which is a byproduct
from cow's milk. Whey protein provides significant advantages over other types of
protein because it contains all of the essential amino acids required in the daily diet, is
more soluble than other proteins, is easily and rapidly digestible, and typically includes
bioactive proteins such as lactoglobulins, immunoglobulins, alpha-lacatlbumin, bovine
serum albumin, lactoperoxidase, and lactoferrins. Whey protein further includes branched
chain amino acids (BCAAs), which are known to assist with protein synthesis.
Many proteins, including whey, are provided in either the isolate form or the concentrate
form. Whey protein concentrates include significant amounts of whey proteins, but
further include lactose and fat, which may be undesirable. Whey protein concentrate is a
mixture in which the amount of the whey proteins is between about 25% and less than
about 80%. In contrast, whey protein isolate is a mixture in which at least about 80% of
the solids are whey proteins. Whey protein isolates are preferred because they can be
purified to remove lactose, fat, cholesterol, carbohydrates, and any other undesirable
components prior to inclusion in the nutritional powder of the present disclosure.
Therefore, whey protein isolates typically include whey protein with minimal amounts of
lactose and fat.
One advantage of whey proteins over other types of proteins is the stability that whey
proteins demonstrate in a variety of processing conditions. For example, whey proteins
are soluble and have an isoelectric point of about 4.5. The isoelectric point being the pH
in which the net charge of the protein is 0. Whey proteins are known to remain soluble
over a wide range of pH's, including at their isoelectric points, which make them
preferred for use in the nutritional powder of the present disclosure over numerous other
proteins. Therefore, any protein that remains substantially clear when utilized in a low pH
solution (i.e., between about 1 pH to about 6 pH) is preferable for use in the powder and
beverage disclosed herein as opposed to any protein that precipitates in a low pH solution.
Whey protein isolates useful in the present disclosure preferably remain soluble at their
isoelectric points such that the beverage remains substantially clear when the protein is
dissolved therein. The whey protein isolate should also be heat stable during
pasteurization and have excellent stability and solubility properties in an acidic solution.
The whey protein isolate further should be easily digestible and provide a good source of
proteins and amino acids, as described above. Any proteins meetings such requirements
would be useful for use in the nutritional powders disclosed herein.
Suitable proteins for use in the nutritional powder of the present disclosure are, for
example, any of the 9000 series whey protein isolates, such as Hilmar™ 9420 whey
protein isolate supplied from Hilmar Ingredients (Hilmar, California, United States). The
whey protein isolate preferably includes at least about 80% protein by dry weight, less
than about 5% lactose, and less than about 1% fat. The moisture content of the whey
protein isolate is typically about 4% and includes a protein efficiency ratio of about 3. A
typical amino acid profile of a preferred whey protein isolate is shown in Table 1.
Various other proteins may be useful for use in the powder and beverage disclosed herein.
For example, a soy protein isolate sold under the trade name Clarisoy™ supplied by
Archer Daniels Midland (Decatur, Illinois) may be useful in the powder and beverage of
the present disclosure.
TABLE 1
A typical amino acid profile of a whey protein isolate useful as the
protein source in the nutritional powder of the present disclosure.
Amino Acid Amount represented as g/lOOg of product
Alanine 3-5
Arginine 2-4
Aspartic Acid 8-12
Cystine/Cysteine 1-3
Glutamic Acid 16-19
Glycine 1-3
Histidine 1-3
Hydroxyproline 0-2
Isoleucine 4-7
Leucine 8-12
Methionine 2-5
Phenylalanine 1-4
Proline 4-7
Serine 3-6
Threonine 5-8
Tryptophan 1-3
Tyrosine 1-4
Valine 4-7
*A11 numbers in the chart are proceeded by the term "about."
The protein source additionally comprises a fatty acid source. One suitable fatty acid
profile of the protein source as represented by g/100 g of the protein source includes
between about 0.08 and about 0.14 saturated fatty acids, between about 0.01 and about
0.06 monosaturated fatty acids, between about 0.04 and about 0.08 polyunsaturated fatty
acids, and less than about 0.01 trans fatty acids. Further, the ratio of saturated fatty acids
to monosaturated fatty acids is about 8:1, or about 7:1, or about 6:1, or about 5 :1, or about
4:1, or about 3:1, or about 2:1. The ratio of monosaturated fatty acids to polyunsaturated
fatty acids is about 1:4, or about 1:5, or about 1:6, or about 1:7, or about 1:8, or about 3:4,
or about 3:1, or about 3:2.
As disclosed herein, the protein source may be provided as a single protein source or may
be a combination of various protein sources. In one embodiment, the protein source is
provided as whey protein isolate. In a different embodiment, the protein source is
provided as a mixture of a vegetable protein and a whey protein. In a further
embodiment, the protein source is provided as a soy protein isolate. In still a further
embodiment, the protein source is provided as a mixture of a soy protein isolate and a
whey protein isolate. In another embodiment, the protein source is provided as a
vegetable protein and a soy protein isolate. In a further embodiment, the protein source is
provided as a vegetable protein.
Generally, the protein source is included in the nutritional powder in an amount (by
weight of the nutritional powder) of from about 5% to about 40%, or from about 5% to
about 35%, or from about 5% to about 33%, or from about 15% to about 35%, or from
about 10% to about 40%, or from about 10% to about 35%, or from about 10% to about
33%, or from about 10% to about 30%, or from about 20% to about 40%, or from about
2 0% to about 35%, or from about 20% to about 30%, or from about 25% to about 35%, or
from about 25% to about 30%, or from about 25% to about 32%, or from about 28% to
about 32%, or from about 29% to about 33%, or about 31% to about 33%. In some
embodiments, the protein may be included in the nutritional powder in a specific amount
of about 5%, about 10%, about 15%, about 20%, about 25%, about 28%, about 29%,
about 30%, about 31%, about 32%, about 33%, about 34%, or about 35%, or about 36%,
or about 37%, or about 38%, or about 39% (by weight of the nutritional powder).
Preferably, the protein source does not comprise more than about 41% of the nutritional
powder because the reconstituted beverage formed by the nutritional powder may become
excessively cloudy and the beverage flavor may be compromised, which are both
undesirable characteristics with respect to the reconstituted beverage of the present
disclosure. Without being bound by theory, it is thought that the higher the protein
content of the nutritional powder (i.e., greater than about 50% by weight of the nutritional
powder), typically the more obstacles that are presented with respect to maintaining a
substantially translucent beverage that has been formed from reconstituting the nutritional
powder. However, it is possible that a larger amount of the protein source could be
present in the nutritional beverage so long as the greater than about 50% amount of
protein source does not negatively impact the translucency of the nutritional beverage.
A further way of characterizing the protein source is through the amount of protein
present in relation to the calories of the reconstituted beverage. In particular, the protein
source of the present disclosure is included in an amount between about 2 grams/ 100 kcal
to about 15 grams/ 100 kcal, or about 5 grams/ 100 kcal to about 12 grams/ 100 kcal, or
about 6 grams/ 100 kcal to about 10 grams/ 100 kcal of the nutritional powder. In some
embodiments, the protein source is provided in the nutritional powder in an amount of
about 6 grams/ 100 kcal, or about 7 grams/ 100 kcal, or about 8 grams/ 100 kcal, or about 9
grams/100 kcal, or about 10 grams/100 kcal.
The protein source may be prepared in manners known in the nutritional art. For
example, the protein source may be supplied in powder form after undergoing a spray-dry
process, which is a method of producing a powder by rapidly drying a slurry or liquid
with a hot gas. In its final, powder form, the protein source preferably is homogenous,
substantially non-caking, substantially non-clumping, and free flowing.
LIPID SOURCE
The nutritional powder of the present disclosure further includes at least one lipid source.
Suitable lipid sources include, but are not limited to, coconut oil, soy oil, corn oil, olive
oil, safflower oil, high oleic safflower oil, MCT oil (medium chain triglycerides),
sunflower oil, oleic sunflower oil, palm oil, palm olein, and canola oil. A preferred lipid
source of the nutritional powder comprises at least one fatty acid, and more particularly,
comprises at least one omega-3 fatty acid. Other types of essential and fatty acids may be
used alone or in combination with omega-3 fatty acids such as, for example, omega-6 and
omega 9 fatty acids. Types of fatty acids useful for inclusion in the nutritional powder
include, for example, docosahexaenoic acid (DHA), docosapentaenoic acid (DPA),
arachidonic acid (ARA), alpha-linolenic acid (ALA), eicosapentaenoic acid (EPA),
eicosatetraenoic acid (ETA), stearidonic acid (SDA) and heneicosapentenoic acid.
A particularly useful fatty acid useful for the nutritional powder of the present disclosure
is DHA. DHA is a long-chain omega-3 fatty known for its nutritional benefits to adults,
embryos, and children as described herein. Lipid sources of DHA include, but are not
limited to, marine/fish oil, egg yolk oil, squid oil, and plant oils including echium oil,
flaxseed oil, and fungal oil.
Marine/fish oils are oils that are obtained from aquatic animals, plants or organisms, either
directly or indirectly, particularly from oily fish. Marine oils include, for example,
herring oil, cod oil, anchovy oil, tuna oil, sardine oil, menhaden oil and algae oil.
Although omega-3 fatty acids can be obtained from other sources, such as plant oils, fish
have a unique ability to provide high levels of the omega-3 fatty acids DHA and EPA.
Although DHA and other optionally included fatty acids may be supplied in any form,
DHA and other optional fatty acids are preferably supplied as a microencapsulated fish oil
powder. The microencapsulation assists in preventing an unpleasant fishy-odor in the
nutritional powder and the resulting beverage formed by reconstituting the nutritional
powder. A suitable microencapsulated fish oil powder is, for example, MEG-3® powder
supplied by Ocean Nutrition Canada (Nova Scotia, Canada). Although DHA is
specifically contemplated, other fatty acids providing nutritional benefits consistent with
the disclosure herein may be useful for inclusion in the nutritional powder disclosed
herein.
In one embodiment, the lipid source comprises a fatty acid. In a different embodiment,
the lipid source comprises DHA. In yet a different embodiment, the lipid source
comprises DHA and EPA. In another embodiment, the lipid source comprises DHA in
conjunction with any other fatty acid. In embodiments having DHA and EPA, the lipid
source includes DHA in an amount of at least about 132 mg/g, in conjunction with EPA in
an amount of about 36 mg/g to about 72 mg/g.
Generally, the lipid source is included in the nutritional powder in an amount (by weight
of the nutritional powder) of from about 0.01% to about 3%, or from about 0.01% to 2%,
or from about 0.05% to about 1%, or from about 0.025% to about 2%, or from about
0.0150% to about 0.0175%, or from about 0.0150% to about 0.0190 %, or from about
0.01% to about 0.02%, or from about 0.015 % to about 0.02%, or from about 0.0170% to
about 0.0180%, or from about 0.015% to about 0.02%, or from about 0.001% to about
0.02%, or from about 0% to about 0.02%, or from about 0.01% to about 0.02%. In some
embodiments, the lipid source is included in the nutritional powder in a specific amount of
about 0.01%, about 0.015%, about 0.016%, about 0.017%, about 0.0175%, about 0.018%,
about 0.0185%, about 0.019%, about 0.2%, about 0.3%, about 0.4%, or about 0.5%, or
greater than 0.5%> (by weight of the nutritional powder). Preferably, the lipid source does
not constitute more than about 4% by weight of the nutritional powder because a greater
quantity of lipids increase the turbidity of the beverage.
The lipid source of the present disclosure is included in an amount between about 0.1
grams/100 kcal to about 1 grams/100 kcal, or about 0.2 grams/100 kcal to about 0.8
grams/100 kcal, or about 0.3 grams/100 kcal to about 0.6 grams/100 kcal of the nutritional
powder. In some embodiments, the lipid source is provided in the nutritional powder in
an amount of about 0.2 grams/100 kcal, or about 0.3 grams/100 kcal, or about 0.4
grams/100 kcal, or about 0.5 grams/100 kcal, or about 0.6 grams/100 kcal, or about 0.7
grams/100 kcal.
CARBOHYDRATE SOURCE
The nutritional powders of the present disclosure further include at least one carbohydrate
source, and more preferably include a carbohydrate system chosen to control post-meal
glucose and insulin response. Suitable carbohydrate systems typically include one or
more of slow digesting simple carbohydrates, complex carbohydrates, non-absorbing
carbohydrates, and indigestible carbohydrates. The carbohydrate system may include all
of the carbohydrate sources present in the nutritional composition such that the nutritional
composition does not contain any other carbohydrates sources, or may include only a
portion of the carbohydrate sources present in the nutritional composition; that is, in some
embodiments there are additional carbohydrate sources present in the nutritional
composition in addition to the carbohydrate system as described herein such as, for
example, lactose.
Suitable carbohydrates for use in the nutritional powder include simple or complex,
lactose-containing or lactose-free, or combinations thereof. Non-limiting examples
include hydrolyzed, intact, naturally and/or chemically modified cornstarch, maltodextrin,
maltose, glucose polymers, sucrose, corn syrup solids, rice or potato derived
carbohydrate, glucose, fructose, lactose, and oligosaccharides such as
fructooligosaccharides (FOS) and galacto-oligosaccharides (GOS), insulin, polydextrose,
resistant starches, dextrin, and gums (i.e., Arabic), and combinations thereof. The
carbohydrate source may be either organic or non-organic in nature.
The carbohydrate systems as described herein comprise specific combinations of
individual carbohydrates that have a low glycemic index, generally less than 55.
The carbohydrate systems of the present disclosure include a simple carbohydrate that has
a slow rate of digestion. Simple carbohydrates include those carbohydrates that are
comprised of monosaccharide sugars or disaccharide sugars. Carbohydrates that have a
slow rate of digestion are those carbohydrates that are low glycemic and low insulinemic
and are carbohydrates that generally provide a gradual, relatively low rise in blood
glucose over time. Suitable simple carbohydrates that have a slow rate of digestion that
are suitable for use in the carbohydrate system include isomaltulose, sucromalt, and
combinations thereof. Sucromalt may be made from the enzymatic conversion of sucrose
and maltose into a fructose and oligosaccharide liquid syrup. The oligosaccharide is
comprised of glucoses linked together by alternating 1,3 and 1,6 linkages.
The simple carbohydrate that has a slow rate of digestion may be present in the
carbohydrate system in an amount of from about 30% to about 90% by weight, including
from about 40%> to about 80%> by weight, including from about 50%> to about 75%> by
weight, including from about 45% > to about 75% > by weight, including from about 55%> to
about 75% by weight, including from about 55%> to about 80%> by weight, including from
about 60% to about 80%> by weight, including from about 65%> to about 75%> by weight.
In some specific embodiments, the simple carbohydrate that has a slow rate of digestion
may be present in the carbohydrate system in an amount of about 65% by weight, or even
about 70% by weight, or even about 71%> by weight, or even about 72%> by weight, or
even about 73% >by weight, or even about 75% >by weight.
In addition to the simple carbohydrate that has a slow rate of digestion, the carbohydrate
system includes a complex carbohydrate. Complex carbohydrates include those
carbohydrates that are chains of three or more single sugar molecules linked together.
Suitable complex carbohydrates for use in the carbohydrate system include, for example,
maltodextrins. In some particularly desirable embodiments, the maltodextrins will have a
Dextrose Equivalent of from 9 to 16. Other suitable complex carbohydrates in some
embodiments include other sources of starches such as, for example, corn starch, rice
starch, wheat starch, and the like.
The complex carbohydrate may be present in the carbohydrate system in an amount of
from about 1% to about 15% by weight, including from about 2% to about 12% by
weight, including from about 2% to about 10%> by weight, including from about 3% to
about 10% by weight, including from about 4% to about 10% by weight, including from
about 5% to about 10% by weight, including from about 6% to about 10% by weight,
including from about 7% to about 10% by weight, and including from about 8% to about
10% by weight. In some particularly desirable embodiments, the complex carbohydrate is
present in the carbohydrate system in an amount of about 8% by weight, including about
9% by weight, including about 10% by weight.
In addition to the simple carbohydrate that has a slow rate of digestion and the complex
carbohydrate, the carbohydrate systems as described herein additionally include at least
one of: (1) a nonabsorbent carbohydrate; and (2) an indigestible oligosaccharide. In some
embodiments of the present disclosure, the carbohydrate system will comprise, consist
essentially of, or consist of a simple carbohydrate that has a slow rate of digestion, a
complex carbohydrate, and a nonabsorbent carbohydrate. In other embodiments of the
present disclosure, the carbohydrate system will comprise, consist essentially of, or
consist of a simple carbohydrate that has a slow rate of digestion, a complex carbohydrate,
and an indigestible oligosaccharide. In still other embodiments of the present disclosure,
the carbohydrate system will comprise, consist essentially of, or consist of a simple
carbohydrate that has a slow rate of digestion, a complex carbohydrate, a nonabsorbent
carbohydrate, and an indigestible carbohydrate. In some embodiments, as noted above,
one or more additional carbohydrates, such as lactose, may be present in addition to the
carbohydrate system.
The carbohydrate system further includes a nonabsorbent carbohydrate. Nonabsorbent
carbohydrates include fibers and other non-absorbable starches that are not substantially
absorbed in the upper intestinal tract so that they pass through to the colon where bacteria
ferment them into fatty acids that can be absorbed. These fatty acids may act to heal the
lining of the colon. Suitable nonabsorbent carbohydrates include inulin, and insoluble
dietary fibers, including Fibersol® fibers, including Fibersol® 2E (a digestion resistant
maltodextrin), Nutriose® (wheat and corn derived dietary fiber), amylose, or other
insoluble fibers, and combinations thereof.
The nonabsorbent carbohydrate may be present in the carbohydrate system in an amount
of from about 5% to about 25% by weight, including from about 5% to about 20%> by
weight, including from about 5% to about 19%> by weight, including from about 5% to
about 18%o by weight, including from about 5% to about 17% by weight, including from
about 5%o to about 16% by weight, including from about 7% to about 17% by weight,
including from about 10% to about 17% by weight. In some particularly desirable
embodiments, the nonabsorbent carbohydrate is present in the carbohydrate system in an
amount of about 12% by weight, including about 14% by weight, including about 16% by
weight, and including about 18% by weight.
The carbohydrate system also includes an indigestible carbohydrate. Indigestible
carbohydrates are carbohydrates, including some fibers that travel through the colon
undigested so as to promote digestion and a healthy bowel. Suitable indigestible
carbohydrates include fructooligosaccharides, galactooligosaccharides, transgalactooligosaccharides,
xylooligosaccharides, and combinations thereof.
The indigestible carbohydrate may be present in the carbohydrate system in an amount of
from about 1% to about 18% by weight, including from about 2% to about 17% by
weight, including from about 2% to about 15% by weight, including from about 3% to
about 15% by weight, including from about 3% to about 14% by weight, including from
about 3% to about 13% by weight, including from about 3% to about 12% by weight. In
one particularly desirable embodiment, the indigestible carbohydrate is present in the
carbohydrate system in an amount of about 3% by weight.
In a particularly desirable embodiment, the carbohydrate system comprises about 71% by
weight isomaltulose, about 9% by weight maltodextrin having a DE of 9 to 16, about 4%
by weight fructooligosaccharides, and about 16% by weight Fibersol 2E insoluble dietary
fiber.
Generally, the carbohydrate system is included in the nutritional powder in an amount (by
weight of the nutritional powder) of from about 5% to about 80%, or from about 10% to
about 70%, or from about 10%> to about 60%>, or from about 20%> to about 60%>, or from
about 2 0% to about 50%>, or from about 30%> to about 70%>, or from about 30%> to about
60%, or from about 40%> to about 70%> or from about 40%> to about 60%>, or from about
4 0% to about 55%, or from about 45% to about 55%, or from about 50% to about 55%, or
from about 50% to about 60%, or from about 51% to about 57%. In some embodiments,
the carbohydrate system may be included in the nutritional powder in a specific amount of
about 5%, about 10%, about 20%, about 30%, about 35%, about 40%, about 45%, about
50%, about 5 1%, about 52%, about 53%, about 54%, about 55%, or even about 60% (by
weight of the nutritional powder). The carbohydrate system may be included in the
nutritional powder in a higher amount (i.e., greater than about 60%), however such
inclusion increases the caloric content of the resulting beverage, which may be
undesirable for certain nutritional beverages.
The carbohydrate system of the present disclosure is included in an amount between about
6 grams/100 kcal to about 40 grams/100 kcal, or about 10 grams/100 kcal to about 30
grams/100 kcal, or about 12 grams/100 kcal to about 20 grams/100 kcal of the nutritional
powder. In some embodiments, the carbohydrate source is provided in the nutritional
powder in an amount of about 12 grams/100 kcal, or about 14 grams/ 100 kcal, or about 16
grams/100 kcal, or about 18 grams/100 kcal, or about 20 grams/100 kcal.
NUTRIENT SOURCE
The nutritional powders of the present disclosure comprise sufficient types and amounts
of nutrients to meet the targeted dietary needs of the intended user. These nutritional
powders therefore include a protein source, a carbohydrate source, and a lipid source (all
either organic or non-organic) in addition to vitamins, minerals, and/or other components
suitable for use in nutritional powders. Many different sources and types of
macronutrients and micronutrients are known and can be used in the nutritional powders
of the present disclosure, provided that such nutrients are compatible with the added
components in the selected formula, are safe for their intended use, and do not otherwise
unduly impair product performance.
Accordingly, the nutritional powders of the present disclosure may further comprise any
of a variety of vitamins and minerals in addition to the components described above. The
vitamins may be prepared as a premix or may be mixed into the nutritional powder
separately. Non-limiting examples of vitamins include vitamin A, vitamin D, vitamin E,
vitamin K, thiamine, riboflavin, pyridoxine, vitamin B 12, niacin, folic acid, pantothenic
acid, biotin, vitamin C, choline, chromium, carnitine, inositol, salts and derivatives
thereof, and combinations thereof. The nutritional powders may further comprise any of a
variety of minerals, non-limiting examples of which include calcium, phosphorus,
magnesium, iron, zinc, manganese, copper, iodine, sodium, potassium, chloride, and
combinations thereof. Alternatively, or in combination with other nutrients, a water
dispersible oil soluble vitamin premix could be added to the powder of the present
disclosure.
One suitable vitamin premix includes the components found in Table 2.
TABLE 2
A typical vitamin premix profile useful for use in the nutritional powder of the present
disclosure.
Vitamin Amount represented as kg/1000 kg of product *
Lactose 3-5
Zinc Sulfate Monohydrate 0-1
Ferrous Sulfate Monohydrate 0-1
Vitamin E Acetate 0-1
Niacinamide 0-0.1
Manganese Sulfate Monohydrate 0-0.1
d-calcium Pantothenate 0-0.1
Copper Sulfate Anhydrous 0-0.1
Pyridoxine Hydrochloride 0-0.1
Thiamine Hydrochloride 0-0.1
Riboflavin 0-0.1
Folic Acid 0-0.01
Vitamin A Palmitate 0-0.01
Chromium Chloride 0-0.01
Cholecalciferol 0-0.01
Sodium Selenate 0-0.01
d-Biotin 0-0.001
Phytonadione 0-0.001
Cyanocobalamin 0-0.0001
*A11 numbers in the chart are proceeded by the term "about."
FLAVOR SOURCE
The nutritional powder of the present disclosure further optionally includes one or more
flavoring sources to provide flavoring to the reconstituted beverage. In particular, the
flavoring sources preferably impart a palatable flavor to water. The flavoring sources
may comprise natural or artificial flavors including fruit, vegetable, botanical flavors and
the like. The flavors can be natural or synthetically prepared to simulate flavors derived
from natural sources. Further, the flavoring source may comprise one or more fiavors
either alone, or in combination with other flavor sources. The flavoring sources are
preferably supplied in dry form so as to easily b e incorporated into the nutritional powder
of the present disclosure. Examples of suitable flavoring sources include punch, berry,
orange, pineapple, peach, lemon, lime, banana, grape, and the like. Preferably, the
flavoring sources do not comprise chocolate or vanilla flavoring similar to those found in
prior art shake products due to the unfavorable flavor profile with respect to pregnant
women, and the solubility issues presented by chocolate and vanilla flavoring.
The flavoring sources are preferably incorporated into the nutritional powder in an
amount of about 0.01 wt % to about 0.1 wt %, or about 0.01 wt % to about 0.09 wt %, or
about 0.01 wt % to about 0.08 wt %, or about 0.01 wt % to about 0.07 wt %, or about 0.03
wt % to about 0.08 wt %.
The ratio of various sources in the nutritional powder is important to help realize the
advantages discussed herein. For example, the ratio of the protein source to carbohydrate
system in the nutritional powder is about 0.1:1, or about 0.2:1, or about 0.3:1, or about
0.4:1, or about 0.5:1, or about 0.55:1, or about 0.6:1, or about 0.65:1, or about 0.7:1, or
about 0.8:1, or about 0.9:1, or about 1:1. The ratio of the lipid source to the protein source
is about or about 0.01:1, or about 0.02:1, or about 0.03:1, or about 0.04:1, or about 0.05:1,
or about 0.06:1, or about 0.07:1, or about 0.08:1, or about 0.09:1, or about 0.1:1. The
ratio of the lipid source to the carbohydrate system is about 0.001:1, or about 0.002:1, or
about 0.003:1, or about 0.004:1, or about 0.05:1, or about 0.06:1, or about 0.07:1, or about
0.08:1, or about 0.09:1, or about 0.1:1.
The nutritional powder is typically formulated utilizing the components described herein
in the embodied ranges in the Table 3.
TABLE 3
Various embodiments of the nutritional powder described herein.
Source Embodiment 1 Embodiment 2 Embodiment 3
Protein 10-40 20-40 22-27
Carbohydrate 20-70 40-60 49-53
Lipid Less than 5 Less than 3 About 1
Amounts expressed as weight % of the total nutritional powder. All amounts are preceded
by the "about."
PRODUCT FORM
The nutritional powders of the present disclosure may have any caloric density suitable
for the targeted or intended patient population, or provide such a density upon
reconstitution of the nutritional powder. The nutritional powders of the present disclosure
are typically in the form of flowable or substantially flowable particulate compositions, or
at least particulate compositions that can be easily scooped and measured with a spoon or
similar other device, wherein the compositions can easily be reconstituted by the intended
user with a suitable aqueous fluid, typically water, to form a liquid nutritional supplement.
Powder embodiments include spray dried, dry mixed or other known or otherwise
effective particulate form. The quantity of a nutritional powder required to produce a
volume suitable for one serving may vary.
The nutritional powders of the present disclosure may be packaged and sealed in single or
multi-use containers, and then stored under ambient conditions for up to about 36 months
or longer, more typically from about 12 months to about 24 months. For multi-use
containers, these packages can be opened and then covered for repeated use by the
ultimate user, provided that the covered package is then stored under ambient conditions
(e.g., avoid extreme temperatures and moisture) and the contents used within about one
month or so. One particularly preferred packaging configuration is single-use, singleserve
packets. Each packet preferably contains a sufficient amount of nutritional powder
suitable for use in a single serving of a beverage. For example, depending on the desired
nutrient and energy profiles of the reconstituted beverage, the serving size for each packet
may include about 70 grams of powder, or about 60 grams, or about 50 grams, or about 40
grams, or about 30 grams, or about 20 grams, or about 15 grams, or about 10 grams, or
about 5 grams.
METHOD OF MANUFACTURE
The nutritional powders of the present disclosure may be prepared by any known or
otherwise effective technique suitable for making and formulating a nutritional powder or
similar other supplemental powder, variations of which may depend upon variables such
as the ingredient combination, packaging and container selection, and so forth, for the
desired nutritional powder. Such techniques and variations for any given supplemental
powder are easily determined and applied by one of ordinary skill in the nutritional
powder arts.
The nutritional powders of the present disclosure, including the exemplified powders
described hereinafter, can therefore be prepared by any of a variety of known or otherwise
effective formulation or manufacturing methods. One such method described
hereinbelow involves dry blending the powder components at specified mixing
conditions. Other methods may involve the initial formation of an aqueous slurry
containing carbohydrates, proteins, lipids, stabilizers or other formulation aids, vitamins,
minerals, or combinations thereof. The slurry is emulsified, pasteurized, homogenized,
and cooled. Various other solutions, mixtures, or other materials may be added to the
resulting emulsion before, during, or after further processing. This emulsion can then be
further diluted, heat-treated, and subsequently dried via spray-drying or the like to
produce a nutritional powder. Other suitable methods of producing a nutritional powder
are described, for example, in U.S. Pat. No. 6,365,218 (Borschel, et al), U.S. Pat. No.
6,589,576 (Borschel, et al), U.S. Pat. No. 6,306,908 (Carlson, et al), U.S. Patent
Application No. 200301 18703 (Nguyen, et al), all of which are hereby incorporated by
reference.
NON-HYGROSCOPIC COMPONENTS
The nutritional powder of the present disclosure preferably includes favorable solubility
properties and does not clump if exposed to the ambient atmosphere. Powders of the prior
art typically accomplish the aforementioned goals by using anti-caking agents because the
powders utilize hygroscopic materials, which tend to become damp and "cake" when
exposed to moisture. In contrast, the nutritional powders of the present disclosure
preferably include at least one non-hygroscopic component, which is a component that
does not readily absorb moisture. The hygroscopic nature of a material can be measured
by various properties relating to the moisture retention of the material. Examples of
suitable non-hygroscopic components suitable for use in the powder of the present
disclosure include magnesium phosphate (in lieu of magnesium chloride) and choline
bitartrate premix (in lieu of choline chloride), and citric acid anhydrous (in lieu of citric
acid).
Nutritional powders disclosed herein that include one or more non-hygroscopic
components are typically characterized by lower mean cake strengths than nutritional
formulas of a similar composition using hygroscopic components. Cake strength is the
measure of powder compaction, which directly impacts the dissolution of the powder in
an aqueous liquid. The lower the cake strength value, the better the dissolution properties
of the nutritional powder. One way similar levels of cake strength are typically realized is
through the use of non-caking agents. Thus, the powder of the present disclosure provides
a desirable cake strength without the use of non-caking agents. Preferably, the mean cake
strength of the nutritional powders of the present disclosure is less than about 55 g, or less
than about 50 g, or less than about 45 g, or less than about 43 g, or less than about 40 g, or
less than about 35 g.
PROPERTIES OF THE NUTRITIONAL POWDERS
The nutritional powder of the present disclosure may be characterized using any number
of quantitative measurements. One such measurement is bulk density, which is defined as
the mass of the particles of the powder divided by the volume the particles occupy. The
(poured) bulk density of the powder is between about 0.2 g/cm3 to about 0.10 g/cm3, or
about 0.3 g/cm3 to about 0.9 g/cm3, or between about 0.4 g/cm3 and about 0.7 g/cm3 when
measured freely settled. The (tapped) bulk density of the powder is between about 0.6 g/
cm3 and about 0.10 g/cm3, or between about 0.7 g/cm3 to about 0.9 g/cm3, or about 0.8
g/cm when measured after compaction (i.e., vibration of the container that the powder is
contained within).
OPTIONAL COMPONENTS
The nutritional powders of the present disclosure may further comprise other optional
components that may modify the physical, chemical, aesthetic or processing
characteristics of the formulas or serve as pharmaceutical or additional nutritional sources
when used in the targeted population. Many such optional components are known or
other suitable for use in food and nutritional products and may also be used in the
nutritional powders of the present disclosure, provided that such optional materials are
compatible with the essential materials described herein, are safe for their intended use,
and do not otherwise unduly impair product performance. Non-limiting examples of such
optional components include preservatives, anti-oxidants, emulsifying agents, buffers,
colorants, flavors, nucleotides, and nucleosides, probiotics, prebiotics, lactoferrin, and
related derivatives, thickening agents and stabilizers, and so forth.
A further optional component includes beta-hydro xy-beta-methylbutyrate (HMB). HMB
is a metabolite of the essential amino acid leucine and has the IUPAC name 3-hydroxy-3-
methylbutanoic acid. A preferred form of HMB is the calcium salt of HMB, also
designated as Ca-HMB, which is most typically the monohydrate calcium salt. The HMB
used can come from any source. Calcium HMB monohydrate is commercially available
from Technical Sourcing International (TSI) of Salt Lake City, Utah. Although calcium
monohydrate is the preferred form of HMB for use herein, other suitable sources include
HMB as a free acid, a salt, an anhydrous salt, an ester, a lactone, or other product forms
that provide a bioavailable form of HMB suitable for administration. Nonlimiting
examples of suitable salts of HMB for use herein include HMB salts, hydrated or
anhydrous, of sodium, potassium, chromium, calcium, or other non-toxic salt forms.
RECONSTITUTED BEVERAGE
The nutritional powder of the present disclosure is adapted to be reconstituted using an
aqueous liquid. Preferably, the aqueous liquid is water. However, it is contemplated that
other types of liquids may be used such as, for example, juice, tea, coffee, and the like.
The aqueous liquid may contain flavoring or may be flavorless. The nutritional powder
may be added into a container having the liquid previously disposed therein or may be
added to an empty container, with the liquid being added after the powder. The beverage
is preferably prepared by mixing, stirring, shaking, or any other method that assists in
dissolving the powder into the liquid. Once the powder is dissolved, the reconstituted
beverage exhibits the desirable characteristics described herein.
The reconstituted beverage comprises the various components discussed herein according
to the following embodiment shown in Table 4, which comprises 47.5 g of nutritional
powder dissolved in 226.8 grams (8 ounces) of water.
TABLE 4
An embodiment of a reconstituted beverage formed from the nutritional powder
described herein.
Component Amount Amount Per 28.3 grams ( 1 ounce)
Energy 148.5 kcal 18.6 kcal
Protein g 1.5 g
Lipids 0.5 g 0.0625 g
DHA 100 mg 12.5 mg
Carbohydrate 24 g 3 g
Sugar 16.3 g 2 g
Fiber 1.6 g 0.2 g
All amounts are preceded by "about."
The reconstituted beverage includes a favorable solubility profile. The time that the
powder dissolves in the liquid is dependent on multiple factors including serving size,
liquid size, amount of powder, temperature of the liquid, and such. In particular, the
powder preferably dissolves such that the liquid is substantially homogenous after mixing
over a time period of less than about 500 seconds.
The reconstituted beverage is preferably translucent, meaning that the liquid at least
allows light to pass through the beverage. A standard color scale of 0-100 and Agtron
Color Analyzer M-45 is used to determine the relative translucency of the reconstituted
beverage and is known to those in the art. Translucent products are characterized by
lower number on the color scale (i.e., closer to 0). More opaque products are
characterized by larger number on the color scale (i.e., closer to 100). Beverages of the
present disclosure are preferably characterized by a number of less than about 40 on the
color scale, or less than about 30 on the color scale, or less than about 20 on the color
scale, or less than about 15 on the color scale, or less than about 10 on the color scale. In
one embodiment, the beverage is substantially translucent and is characterized by a
number on the color scale of about 10.
The reconstituted beverage preferably includes a balanced pH profile suitable for pregnant
women or other intended consumers of the reconstituted beverage. For example, the
beverage is preferably acidic and is defined by a pH between about 2 and about 6, or
about 2 to about 5, or about 2 to about 4, or about 3 to about 6, or about 3 to about 5, or
about 3 to about 4, or about 4 to about 5, as measured at about typical room conditions
(i.e., about 20 °C to about 25 °C).
The reconstituted beverage further includes a favorable viscosity in accordance with the
advantages described herein. The viscosity of the reconstituted beverage is preferably less
than about 20 cps, or less than about 1 cps, or less than about 15 cps, or less than about
12 cps, or less than about 10 cps, or less than about 9 cps, or less than about 8 cps, or less
than about 7 cps, or less than about 6 cps, or less than about 5 cps. In one embodiment,
the viscosity of the reconstituted liquid is about 6 cps.
The translucent reconstituted beverage of the present disclosure provides a unique
advantage over prior art nutritional supplements by being able to provide sufficient
amounts of protein, carbohydrates, vitamins, and minerals, while at the same time having
a low fat content (less than about 1%) and having a low calorie content (less than about
200). The caloric profile is closely regulated due to the unique mixture of sources in the
nutritional powder and the corresponding reconstituted beverage. The reconstituted
beverage preferably includes less than about 200 calories per 236.6 ml serving (where
236.6 ml is about 8 f oz), or less than about 190 calories per 236.6 ml serving, or less
than about 180 calories per 236.6 ml serving, or less than about 170 calories per 236.6 ml
serving, or less than about 160 calories per 236.6 ml serving, or less than about 150
calories per 236.6 ml serving. In one embodiment, the nutritional beverage includes
between about 100 and about 170 calories per 236.6 ml serving, or between about 120 and
about 150 calories per 236.6 ml serving, or between about 140 and about 150 calories per
236.6 ml serving. The translucent nutritional beverage preferably comprises between
about 282.2 to about 987.7 total kcal/kg (about 8 to about 28 total kcal/ounce), or about
352.7 to about 917.1 total kcal/kg (about 10 to about 26 total kcal/ounce), or about 423.3
to about 846.6 total kcal/kg (about 12 to about 24 total kcal/ounce).
EXAMPLES
The following examples further describe and demonstrate specific embodiments within
the scope of the present disclosure. The examples are given solely for the purpose of
illustration and are not to be construed as limitations of the present disclosure, as many
variations thereof are possible without departing from the spirit and scope of the
disclosure. All exemplified amounts are weight percentages based upon the total weight of
the composition, unless otherwise specified.
Example 1
The following examples illustrate powdered nutritional supplements of the present
disclosure, including methods of making and using the powdered nutritional supplements.
Formula components for the batch are listed in Table 5.
TABLE 5
An exemplary embodiment of the nutritional powder described herein.
Component Amount represented as kg/1000 kg of product
Isomaltulose 372
Whey Protein Isolate (Hilmar 9420) 301
Fibersol 2 84.3
Citric Acid 49.5
Maltrin M200 (maltodextrin) 45.1
Potassium Phosphate Monobasic 27.1
Calcium Carbonate 26.7
Fructooligosaccharides 19.3
Omega-3 Powder 17.5
Magnesium Phosphate 16.6
Sodium Citrate 8.84
Choline Bitartrate Premix 6.95
Potassium Chloride 6.39
Lactose 7.02
Zinc Sulfate Monohydrate 0.683
Ferrous Sulfate Monohydrate 0.435
Vitamin E Acetate 0.430
Niacinamide 0.0628
Manganese Sulfate Monohydrate 0.0586
d-calcium Pantothenate 0.0561
Copper Sulfate Anhydrous 0.0307
Pyridoxine Hydrochloride 0.0294
Thiamine Hydrochloride 0.0191
Riboflavin 0.0111
Folic Acid 0.00867
Vitamin A Palmitate 0.00606
Chromium Chloride 0.00343
Cholecalciferol 0.00291
Sodium Selenate 0.00199
d-Biotin 0.000862
Phytonadione 0.000443
Cyanocobalamin 0.0000467
Punch Flavor 4.63
Ascorbic Acid 2.51
Orange Flavor 2
Anthocyanin Powder Color 0.670
Pineapple Flavor 0.499
Acesulfame Potassium 0.469
Sucralose Powder 0.362
Natural Carotene Powder Color 0.206
Potassium Iodide 0.00100
The exemplified powder of Table 5 is prepared by making at least two separate blends
that are blended together and packaged.
A vitamin premix is prepared and includes lactose, zinc sulfate monohydrate, ferrous
sulfate monohydrate, vitamin E acetate, niacinamide, manganese sulfate monohydrate,
manganese sulfate monohydrate, d-calcium pantothenate, copper sulfate anhydrous,
pyridoxine hydrochloride, thiamine hydrochloride, riboflavin, folic acid, vitamin A
palmitate, chromium chloride, cholecalciferol, sodium selenate, d-Biotin, phytonadione,
and cyanocobalamin. The isomaltulose, choline bitartrate premix, potassium phosphate
monobasic, and vitamin premix are added to a blender and mixed for at least 2 minutes at
a rotational speed of about 18 rpm to form the initial mix. Additionally, the Maltrin M200
is divided into two portions. A first portion comprises about 17.7% of the total and a
second portion comprises about 82.3% of the total amount of Maltrin M200.
A secondary premix is formed by adding the first portion of Maltrin M200, potassium
iodide, pineapple flavor, acesulfame potassium, sucralose powder, natural carotene
powder color, and anthocyanin powder color. The secondary premix is added to a
separate container and mixed. It should be noted that a natural high intensity sweetener
such as Stevia® or Monk fruit powder could be substituted for the sucralose powder.
The secondary premix is added to the blender in addition to the second portion of Maltrin
200, orange flavor, sodium citrate, ascorbic acid, potassium chloride, calcium carbonate,
magnesium phosphate, fructooligosaccharides, Fibersol 2, citric acid, and punch flavor.
These components were added to the blender on top of the initial mix in the order listed
herein. The calcium carbonate and magnesium phosphate dibasic were filtered through a
sieve to remove clumps. After all of the secondary premix and additional components are
added to the blender, the mixture is blended for at least 2 minutes at a rotational speed of
about 18 rpm.
Finally, the Omega-3 powder and whey protein isolate (Hilmar 9420) are added evenly to
the top of the blender onto the other blended components. The mixture is blended for at
least 4 minutes at a rotational speed of about 18 rpm. The resulting nutritional powder is
then packaged in manners known in the art.
The resulting powdered nutritional formula is then used to provide a supplemental,
primary, or sole source of nutrition to pregnant women or other appropriate individuals.
RECONSTITUTED BEVERAGE
The nutritional powder disclosed in Table 5 herein was reconstituted according to the
following method. In particular, 47.5 g of the nutritional powder was added to about
236.6 ml (about 8 f oz) of purified water. The powder was stirred until substantially
dissolved (for about 450 seconds) and until the liquid is homogenous. The homogenous
liquid containing the dissolved powder forms the reconstituted beverage having the
characteristics described herein.
Example 2
A study was conducted to evaluate and compare the physical appearance (i.e.,
translucency) of reconstituted beverages formed from the powdered nutritional
supplements containing a protein source, a lipid source, a carbohydrate system, and
additives as described herein. The nutritional supplement of Table 5 was reconstituted in
236.6 ml (about 8 f oz) of water pursuant to the method described above and was
compared to a typical conventional shake-type protein supplement, Ensure Vanilla (liquid
form) made by Abbott Nutrition (Columbus, Ohio).
One of the preferred ways to measure translucency of a product is to measure the spectral
distribution of light. Changes in any of the gloss, transparency, haziness, and/or turbidity
will affect the manner in which the light is reflected or transmitted through the product.
Any changes of the physical or chemical properties of a product that comprises a
substantially uniform consistency may be measured. A preferred device used to measure
reflectance is a reflectance spectrophotometer. The reflectance spectrophotometer
measures reflective spectral characteristics in monochromatic spectral frequencies.
Standard reflection disks are used to calibrate the reflectance spectrophotometer and the
numerical reading taken on each sample is quantitatively comparable to the calibration
standards. Adjustments may be provided to calibrate the zero and one hundred (100)
points of the spectrophotometer at any desired reflectance level.
The spectrometer provides a measurement when a sample cup containing a homogeneous
product is placed over the viewing port. At that point, light is reflected from the bottom of the
sample cup and passes through a narrow band pass filter, one of the interference filters, and is
focused onto the photodiode sensor. The photodiode provides a current signal which is
proportional to the amount of reflected light from the sample.
The spectrophotometer apparatus is used to measure the distribution of light and includes an
optical viewer and a control console. The spectrophotometer apparatus comprises
monochromatic light sources, interference filters, a photodiode and power supply. The
spectral modes and monochromatic wavelengths employed are: blue (436 nm), green (546
nm), yellow (585 nm), and red (640 nm). Light reflectance at the selected wavelength is read
from the digital display. The spectrophotometer apparatus includes a control console and
viewer (an Autocal Control Console and Viewer, Model M-45), Calibration Disks 00 and 90
(daily operation), sample cups, a transmission disk, a transmission ring, a bolt and wingnut,
and reference calibration disks 00, 90, 10 and 44, supplied by Agtron Inc., (Reno, Nevada,
United States).
Prior to testing, the spectrophotometer apparatus was prepared and calibrated in manners
known in the art. In particular, the spectrophotometer was turned on prior to use and was
positioned in the on position for at least 30 to 60 minutes for the apparatus to warm up.
All parts of the apparatus, disks, rings, and sample cups were cleaned prior to use and free
from scratches, dirt, dust, fingerprints, marks, or other surface irregularities.
The samples were prepared and tested according to the following methodology. First, a
powder having the components of Table 5 was prepared in accordance with the
methodology described herein above. Approximately 47.5 g of the powder was added to
approximately 236.6 ml (about 8 fl oz) of distilled deionized water. The sample was
stirred until the powder was dissolved in the liquid and the sample was substantially
homogeneous. A transmission ring was placed into a sample cup and the sample was
poured into the sample cup over the transmission ring in an amount sufficient to cover the
transmission ring. The transmission disk was added to the sample cup and held in place
with a bolt and wingnut. The sample was then analyzed by the spectrophotometer. A
comparison sample of the laboratory water sample was also tested in a manner consistent
with the testing described herein.
The sample that was compared to the nutritional powder of the present disclosure was
Ensure Vanilla ready-to-drink shake available from Abbott Nutrition. A container having
the sample was opened and the sample was stirred until homogenous. The sample was
poured into the sample cup until the sample cup was about 50% full. The sample was
analyzed in accordance with the above.
In addition to translucency, various characteristics were measured to define the
reconstituted beverage as compared to other beverages for the sake of comparison. For
example, the pHs of the beverages in Table 6 were measured at about room temperature
(about 20° C to about 25° C) using a Mettler S20 pH meter. Additionally, the viscosities
of the beverages in Table 6 were measured at room temperature with a viscometer (Model
DV-II+ PRO supplied by Brookfield Engineering Laboratories).
TABLE 6
Results of translucency test, pH test, and viscosity test between a reconstituted
beverage of the present disclosure, a nutritional drink known in the art, and water.
Sample Agtron Scale (1- pH Viscosity (cps)
100)
Nutritional Powder of Present 10.2 4.24 6
Disclosure
Water 0 7 1
Ensure Vanilla Shake (Liquid Form) 46 6.76 24.8
The data as set forth herein shows that a beverage formed from the nutritional powder of
the present disclosure is substantially more translucent than a thicker nutritional beverage.
In particular, the nutritional powder measured approximately 10.2 on the Agtron color
scale as opposed to the Ensure Vanilla shake product, which measured 46 on the Agtron
color scale. Further, the reconstituted beverage includes an acidic pH as compared to the
Ensure product. Still further, the viscosity of the reconstituted beverage is significantly
lower than that of the prior art nutritional product.
Example 3
A further study was conducted to evaluate and compare the cake strength of powdered
nutritional supplements containing a protein source, a lipid source, a carbohydrate source,
and non-hygroscopic components as discussed herein. This nutritional supplement using
non-hygroscopic components was compared to a similar formulation that substituted
hygroscopic components for various components. In particular, the formulation from
Table 5 was used and compared to a control formulation similar to Table 5, except the
non-hygroscopic components magnesium phosphate and choline bitartrate premix were
used in lieu of magnesium chloride and choline chloride, respectively.
Approximately 100 g of the nutritional formula shown in Table 5 and the control formula
were formulated in accordance with the method described hereinabove. The formulas
were prepared and placed separately into two conventional bowls. The bowls were
exposed to the same atmospheric conditions in the laboratory. For example, the
temperature was during the test was approximately room temperature and the laboratory
was under standard laboratory conditions typical of those in Columbus, Ohio. The
nutritional formula samples were exposed for 3 days.
As shown in FIG. 1, the data as set forth herein shows that the control nutritional powder
having hygroscopic components showed a propensity to clump significantly more than the
nutritional formula of the present invention. In particular, after numerous days exposed to
standard laboratory conditions, clumping was plainly visible in the control nutritional
powder having hygroscopic components. Further, the mean cake strength was measured
for each of the nutritional formulas using a texture analyzer with a powder module
attachment manufactured by Stable Microsystems (Surrey, United Kingdom). The cake
strength was found to be about 41.1 g for the formula of the present disclosure versus
about 64.5 g for the control formula.
CLAIMS
1. A translucent nutritional beverage, comprising:
(a) a protein source in an amount between about 6 grams/ 100 kcal to about 10
grams/100 kcal of the beverage;
(b) a carbohydrate system in an amount between about 1 grams/ 100 kcal to about
20 grams/ 100 kcal of the beverage, wherein the carbohydrate system provided as a
carbohydrate blend that includes from about 60% to about 70%> by weight slow rate of
digestion simple carbohydrate, from about 6%> to about 10%> by weight complex
carbohydrate, from about 5% to about 20% by weight nonabsorbent carbohydrate, and
from about 2% to about 15% by weight indigestible carbohydrate; and
(c) a lipid source in an amount between about 0.2 grams/100 kcal to about 0.8
grams/100 kcal of the beverage.
2. The translucent nutritional beverage of claim 1, wherein the beverage
includes about 1.5 grams of the protein source per 28.3 grams of beverage.
3. The translucent nutritional beverage of claim 1, wherein the beverage is
characterized by a number on the Agron color scale of about 10.
4. The translucent nutritional beverage of claim 1, wherein the beverage is
characterized by a pH of between about 2 and about 6.
5. The translucent nutritional beverage of claim 1, wherein the viscosity of
the beverage is less than about 10 cps.
6. A nutritional powder, comprising:
(a) a protein source in an amount between about 2 grams/100 kcal to about 15
grams/ 100 kcal of the nutritional powder;
(b) a carbohydrate system in an amount between about 12 grams/100 kcal to about
20 grams/100 kcal of the nutritional powder, the carbohydrate system provided as a
carbohydrate blend that includes from about 60% to about 70%> by weight slow rate of
digestion simple carbohydrate, from about 6%> to about 10%> by weight complex
carbohydrate, from about 5% to about 20% by weight nonabsorbent carbohydrate, and
from about 2% to about 15% by weight indigestible carbohydrate; and
(c) a lipid source in an amount between about 0.2 grams/100 kcal to about 0.8
grams/ 100 kcal of the nutritional powder, wherein the lipid source further includes from
about 50 milligrams/ 100 kcal to about 100 milligrams/ 100 kcal of docosahexaenoic acid
(DHA).
7. The nutritional powder of claim 6, wherein the protein source comprises at
least one of whey protein isolate, soy protein, potato protein, and combinations thereof.
8. The nutritional powder of claim 6, wherein the protein source comprises at
least 80% protein by dry weight, less than about 5% lactose, and less than about 1% fat.
9. The nutritional powder of claim 6, wherein the protein source is present in
the nutritional powder in an amount of about 5% to about 40% by weight of the
nutritional powder.
10. The nutritional powder of claim 6, wherein the lipid source is present in the
nutritional powder in an amount of no more than 4% by dry weight of the nutritional
powder.
11. The nutritional powder of claim 6, wherein the carbohydrate blend
comprises isomaltulose, maltodextrin, fructooligosaccharides, and insoluble dietary fiber.
12. The nutritional powder of claim 6 further including a flavoring source
including at least one flavoring of punch, berry, orange, pineapple, peach, lemon, lime,
banana, grape, and combinations thereof.
13. The nutritional powder of claim 6, wherein the nutritional powder is
characterized by a cake strength of between about 35 grams to about 45 grams.
14. The nutritional powder of claim 6, wherein the ratio of the protein source
to the carbohydrate system is about 3:5.
15. The nutritional powder of claim 6, wherein the powder includes at least
one non-hygroscopic component.
16. The nutritional powder of claim 6, where the (poured) bulk density of the
powder is between about 0.2 g/cm3 and about 0.10 g/cm3, or between about 0.3 g/cm3 to
about 0.9 g/cm3, or between about 0.4 g/cm3 to about 0.7 g/cm3 when measured freely
settled.
17. A method of reconstituting a powder to form a substantially translucent
nutritional beverage, comprising the step of:
dissolving a nutritional powder in an aqueous liquid, wherein the powder
includes a protein source in an amount between about 6 grams/100 kcal to about
10 grams/100 kcal of the nutritional powder, a carbohydrate system in an amount
between about 12 grams/100 kcal to about 20 grams/100 kcal of the nutritional
powder, and a lipid component in an amount between about 0.2 grams/100 kcal to
about 0.8 grams/100 kcal of the nutritional powder to yield the translucent
nutritional beverage that has between about 423.3 total kcal/kg to about 846.6 total
kcal/kg.
18. The method of claim 17, wherein the aqueous liquid is water.
19. The method of claim 17, wherein the substantially translucent nutritional
beverage includes about 1.5 grams of the protein source per 28.3 grams of
beverage.
20. The method of claim 17, wherein the substantially translucent nutritional
beverage is characterized by a pH of less than about 5 and a viscosity of less than
about 6 cps.
| # | Name | Date |
|---|---|---|
| 1 | PD015675IN-NP SPEC FOR E-FILING.pdf | 2015-04-20 |
| 2 | PD015675IN-NP FORM 5.pdf | 2015-04-20 |
| 3 | PD015675IN-NP FORM 3.pdf | 2015-04-20 |
| 4 | PD015675IN-NP Abbott Laboratories_ GPOA.pdf | 2015-04-20 |
| 5 | 3236-DELNP-2015.pdf | 2015-05-20 |
| 6 | 3236-delnp-2015-Form-3-(22-05-2015).pdf | 2015-05-22 |
| 7 | 3236-delnp-2015-Correspondence Others-(22-05-2015).pdf | 2015-05-22 |
| 8 | 3236-delnp-2015-Correspondence Others-(29-05-2015).pdf | 2015-05-29 |
| 9 | 3236-delnp-2015-Assignment-(29-05-2015).pdf | 2015-05-29 |
| 10 | 3236-delnp-2015-Form-3-(07-09-2015).pdf | 2015-09-07 |
| 11 | 3236-delnp-2015-Correspondence Others-(07-09-2015).pdf | 2015-09-07 |