Nutritional liquid supplement beverage and method of making same

A protein containing nutritional supplement that contains from 1 to 10% by weight of whey protein isolate, at least one source of carbohydrate, vitamins, trace minerals and ultra trace minerals and ultra trace minerals. The pH of the liquid nutritional supplement is from about 2.8 to about 3.3 and is essentially devoid of added macro-nutrients and fat. A supplement which is clear and low in viscosity, is produced by preparing (1) an acidified aqueous solution of whey protein isolate having a pH of about 2.8 to about 3.3 and (2) an aqueous solution of carbohydrate; and thereafter combining the two solutions.

TECHNICAL FIELD 
The present invention is in the field of oral liquid nutritional supplement 
beverages. More specially, this invention provides a clear nutritional 
supplement that possesses a thin texture and a highly acceptable mouth 
feel. This invention also relates to a specific process for the 
manufacture of a clear nutritional supplement that contains up to 10% whey 
protein isolate by weight and has a caloric density of at least 1.0 
kcal/ml. 
BACKGROUND 
Nutritional supplements differ generally from nutritionally complete foods 
in that they are not intended to provide all the human nutritional 
requirements, but instead are intended to supplement other nutrition 
sources. 
Taste fatigue is a common problem in patients who require nutritional 
supplements on a regular basis. In addition, some patients, particularly 
the elderly and those with cancer, have taste aberrations and aversions to 
"milky" supplements. The beverage of this invention is a non-milk tasting 
alternative to the mostly milk-based supplements currently available. It 
represents an acceptable and refreshing means of supplementing energy, 
protein, vitamin and mineral intake in those patients who are fired of the 
milk based alternatives. 
The present invention is intended to solve a number of concomitant problems 
attendant to producing a nutritional supplement drink which provides a 
substantially complete source of protein and a substantially complete 
source of carbohydrate at a high caloric density. The beverage of this 
invention also contains vitamins, trace minerals and ultratrace minerals. 
The beverage of this invention has a pleasing appearance (clear) and 
appealing organoleptic properties (a thin texture and good taste). 
In providing a desirable level of protein (such as in the form of proteins, 
peptides and/or amino acids), one of the principal obstacles to be 
overcome is the poor taste of protein hydrolysates commonly used in such 
prior art products as Fortjuice, commercially available from Nutricia, and 
Provide.TM. protein rich drink commercially available from Fresenius. 
While easily incorporated into a nutritional supplement beverage, protein 
hydrolysates have a very objectionable taste that is impossible to mask 
completely with flavorings. These shortcomings make it difficult to obtain 
good patient compliance. As an alternative, intact whey protein, generally 
in the form of isolates or concentrates, can be used to formulate the 
nutritional supplement beverage. Whey protein isolates, due to their 
unique functionality, are the preferred source of protein over whey 
protein concentrates and other protein sources. Although not having the 
poor taste disadvantage of hydrolyzates, intact whey proteins can be 
difficult to incorporate into a nutritional supplement beverage so as to 
provide protein at a most desirable level while also allowing the 
nutritional supplement beverage to bear the most desirable physical and 
textural properties. Whey protein isolates are also viewed as 
nutritionally superior to hydrolyzed vegetable proteins and casein. 
U.S. Pat. No. 4,992,282 discloses a vitamin and mineral fortified beverage 
or beverage concentrate. These beverages may be juice or cola beverages 
that may be carbonated. More specially this patent teaches the use of 
vitamin C in sugar to enhance the body's uptake of nutritionally 
supplemental amounts of iron compounds and calcium compounds. This patent 
does not suggest the use of whey protein nor the critical need for the 
final product pH to be in the range of 2.8 to 3.3 so as to achieve a clear 
product that possesses excellent mouth feel. 
EP Patent 486,425 discloses a liquid oral nutritional formulation 
comprising, based on the total formulation calories, from 40-90% of the 
calories as carbohydrates, from 2 to 30% of the calories as protein, from 
0 to 35% of the calories as fat and from 0 to 17% of the calories as 
fiber, whereby the protein source is at least 60% by weight whey protein 
concentrate and the pH of the formulation is from 3.5 to 3.9. The product 
CitriSource.RTM.-clear liquid nutritional supplement from Sandoz Nutrition 
is believed to be the commercial embodiment of this patent. This patent 
does not suggest the critical need for the use of a whey protein isolate 
and a pH of 2.8 to 3.3 to achieve the unexpected and highly desirable 
results of the present invention. 
Unlike the prior art which produces "milk tasting products" the present 
invention provides a clear oral nutritional supplement which has a juice 
like consistency and flavor. 
All of the shortcomings of the prior art are overcome by the present 
invention along with providing a nutritional supplement beverage which is 
appetizing in appearance by being substantially clear, and is of a thin 
texture and body which gives a pleasing, refreshing mouth feel while at 
the same time containing a significantly high caloric density. As used 
herein the term "thin texture" and "mouth feel" relate to viscosity of the 
product. The product of this invention must have a viscosity of less than 
15 centipoise as determined by a Brookfield viscometer at 72.degree. 
(22.degree. C.) using a #1 spindle at 60 RPM. 
In view of the present disclosure or through practice of the present 
invention, other advantages or the solutions to other problems may become 
apparent. 
SUMMARY OF THE INVENTION 
The present invention includes a nutritional supplement beverage and a 
method of making same. The present invention also includes a nutritional 
supplement beverage prepared by the method of the present invention. 
The nutritional supplement beverage of the present invention, in broadest 
terms, comprises (1) water; (2) from about 1% to about 10% by weight whey 
protein isolate; and (3) at least one source of carbohydrate, with a 
preferred majority of the carbohydrate source being a complex 
carbohydrate. Complex carbohydrates are viewed as nutritionally superior 
to simple sugars such as sucrose. The beverage also includes vitamins, 
trace minerals and ultra-trace minerals, and is essentially free of added 
macro-nutrients. The pH of the nutritional supplement beverage is in the 
range of from about 2.8 to about 3.3, and the caloric density of the 
nutritional supplement beverage is at least 1.00 kcal/milliliter. 
As used herein, the term "comprising" or "comprises" means various 
components can be conjointly employed in the beverages and concentrates of 
the present invention. Accordingly, the terms "comprising essentially of" 
and "consisting of" are embodied in the term comprising. 
The whey protein can be supplied by commercially available sources. 
Preferably the whey protein is a whey protein isolate. Whey protein 
isolate is greater than 90% protein by weight and contains very low levels 
of fat and lactose. Commercially available sources of whey protein isolate 
that are useful in the present invention are BiPRO.RTM. from Le Sueur 
Isolates of Le Sueur, Minnesota; Provon--190 from Avonmore Ingredients, 
Inc. of Monroe, Wis. and Lacprodan 9212 from Royal Proteins, Inc. of 
Rosemont, Ill. Preferably, the nutritional supplement beverage has whey 
protein isolate present in the range of from about 3% to about 5% by 
weight of the formulation. 
The carbohydrate source(s) may be from any carbohydrate source appropriate 
for use in nutritional beverages. The carbohydrate of the formulation may 
be any nutritionally acceptable carbohydrate source or blend of 
carbohydrate sources providing the desired amount of calories. Suitable 
carbohydrate sources include sucrose, glucose, fructose, corn syrup solids 
and maltodextrin. The DE (dextrose equivalent) of the carbohydrate 
component should be at least 10, preferably 20 or greater. It is preferred 
that the nutritional supplement beverage comprise about 15-35% sucrose and 
65-85% maltodextrin based on total carbohydrate. Most preferably 25% 
sucrose and 75% maltodextrin. Artificial sweeteners such as saccharin and 
aspartame may also be used to enhance the organoleptic quality of the 
formulation. 
With respect to the mineral content or macro-nutrient content of the 
instant invention it is one aspect of the invention that no 
macro-nutrients be added to the formulation; other than those that are 
inherent to the raw materials used in the preparation of the formulation. 
Minerals such as sodium, potassium, magnesium, calcium, phosphorous and 
chloride are inherently present in the whey protein isolate, the 
carbohydrate, the water, the vitamins, trace and ultra-trace minerals used 
to produce the product. For example, an inherent concentration level for 
potassium can be in the range of from about 10-30 mg/100 ml, most 
preferably no more than 20 mg/100 ml; while an inherent level for sodium 
can be in the range of from about 20-40 mg/100 ml, most preferably at 
least 30 mg/100 ml. These levels are inherent from the beverage 
components. Although it may be considered of higher nutritional value to 
have the nutritional beverage contain the foregoing minerals or 
macro-nutrients, the presence of these minerals reduces the clarity and 
textural properties of the inventive beverage. Thus, it is one aspect of 
the present invention that the beverage not be supplemented with, or 
essentially devoided of added macro-nutrients. 
The macro-nutrients are generally recognized as sodium, calcium, magnesium, 
phosphorus, chlorine or chloride and potassium. The beverage of this 
invention should not have these elements added unless as a micro-nutrient, 
such as potassium iodide. An aspect of the present invention resides in 
the discovery that intentional addition of substantial amounts of Na, Ca, 
Mg, P, Cl and K will prevent the desired properties of a clear, thin 
texture product having a juice-like mouth feel and a high caloric content. 
High caloric content is important since many patients which usually consume 
a milk-based product like Ensure.RTM. complete nutrition, from Ross 
Products Division of Abbott Laboratories often desire another flavor or 
taste but still need the necessary calories to maintain an appropriate 
level of nutrition. The beverage of this invention provides an adequate 
level of caloric intake in an attractive and palatable form. 
There is no fat component to this invention other than the fat content 
inherent to the raw materials such as the whey protein. Thus, the product 
of the invention is essentially devoid of added fat. 
The final pH of the nutritional supplement beverage of this invention and 
the protein pre-mixed are critical and should be adjusted by addition of 
food grade HCl, malic acid, citric acid, phosphoric acid; or mixtures 
thereof. The preferred acids to modify the pH of the formulation are 
hydrochloric acid (HCl), citric acid and malic acid. A mixture of these 
acids provides the best balance of flavor, clarity and texture (mouth 
feel) in a formulation that contains up to 10% protein by weight and a 
significantly high caloric density (greater than 1.00 kcal/ml). Of the 
total acid system about 20-40 wt. % of 37% hydrochloric, 100% citric and 
100% malic acid is preferred in this invention. 
One aspect of the present invention relates to simultaneously achieving a 
clear, thin, high caloric content beverage that contains trace, 
ultra-trace minerals and vitamins. Those skilled in the nutritional arts 
will readily appreciate what materials would provide the trace and 
ultra-trace minerals. Representative of the ultra-trace minerals useful in 
the present invention are: selenium, chromium and molybdenum. 
Representative of the trace minerals useful in the present invention are: 
iron, zinc, iodine, copper and manganese. 
An additional aspect of the present invention relates to simultaneously 
achieving a clear, thin, high caloric content beverage that contains 
vitamins. Those skilled in the nutritional arts will readily appreciate 
what materials can be used to accomplish the vitamin addition. 
Representative of the vitamins useful in the present invention are: 
pantothenic acid, biotin, vitamin B.sub.12, folic acid, vitamin B.sub.6, 
niacin, ribofiavin, thiamine and vitamin C. 
The product of this invention may also be carbonated using conventional 
technology to produce a beverage having a distinctive flavor. 
The method of the present invention contains the critical feature of the 
addition of acid to an aqueous solution of whey protein isolate so as to 
adjust the pH prior to addition of the carbohydrate portion. It has been 
found by the inventors that acidification of a protein/carbohydrate blend 
results in a finished product which has unacceptably high viscosity and a 
cloudy appearance. The order of addition is also critical to the instant 
invention. Accordingly, the method of the present invention involves 
producing a nutritional supplement beverage through the following steps: 
(1) preparing (a) an aqueous solution of whey protein isolate and (b) an 
aqueous solution of at least one source of carbohydrate; (2) adding acid 
to said aqueous solution of whey protein so as to bring the pH of said 
solution to within the range of from about 2.8 to about 3.3 (to prevent 
denaturation of the whey proteins so they are more completely soluble). 
Acidification of the whey protein isolate slurry to a pH of 3.5 and above 
results in a finished product with an unacceptably high viscosity and a 
cloudy appearance. Therefore, for the beverage of this invention to 
possess the desirable textural and visual attributes and contain a 
significantly high caloric density (greater than 1.00 kcal/ml) a pH of 
below 3.5 is required, preferably a pH of 2.8-3.3; (3) combining the 
aqueous solution of acidified whey protein isolate and the aqueous 
solution of carbohydrate(s) so as to produce a combined solution; and (4) 
subjecting the combined solutions to a high temperature short time process 
(HTST), followed by homogenization (if required) to produce a beverage 
that is clear and possesses a thin texture. The protein solution/slurry 
may be homogenized prior to the pH adjustment. 
The beverage of this invention should be supplemented with trace minerals, 
ultratrace minerals and vitamins (preferably as a water dispersible 
vitamin A, B, E and K premix and oil soluble vitamins). The water 
dispersible vitamin premix are preferably added during the initial step of 
forming the protein solution and prior to the acid addition. The source of 
vitamin A may be vitamin A palmitate, acetate or beta-carotene. 
An additional aspect of the present invention relates to the beverage's 
thin texture. It has been determined that to achieve the goals of thin 
texture and good mouth feel the viscosity of the product should be less 
than 15 centipoise as determined by a Brookfield viscometer at 72.degree. 
(22.degree. C.) using a number one spindle at 60 RPM. 
The invention also includes a nutritional supplement beverage produced in 
accordance with the method described herein. 
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
In accordance with the foregoing summary of the invention, the following 
Example I is one embodiment of the beverage of the present invention and a 
method of its production. Examples II, III and IV are comparative 
experiments outside the scope of this invention and illustrate a few of 
the critical elements of this invention. 
For making a large quantity of the nutritional supplement beverage in 
accordance with the present invention, the whey protein isolate is first 
dissolved in water at approximately 125.degree. F. (52.degree. C.). The 
resultant protein slurry is then adjusted into a pH range of from 2.8 to 
3.3 through the use of an appropriate acid system (i.e. hydrochloric, 
malic and citric acids). The carbohydrate portion of the beverage is 
prepared by dissolving the desired carbohydrate in water at approximately 
175.degree. F. (79.degree. C.). The resulting carbohydrate slurry is then 
added to the pH-adjusted protein slurry. This mixture is then subjected to 
a high temperature-short time (HTST) process at about 165.degree. F. 
(74.degree. C.) for 16 seconds; followed by homogenization at 2500 psig 
(17,237 kPa). 
It is preferred that the major portion of the carbohydrate component be a 
complex carbohydrate, preferably a high maltodextrin content mixture of 
75% maltodextrin with a DE of between 10 and 20, preferably 20, and 25% 
sucrose. 
Following the HTST process, the mixture is then cooled to approximately 
40.degree. F. (4.degree. C.). To this mixture is then added trace mineral, 
ultratrace mineral and vitamin premixes. Such minerals may include 
potassium iodide and/or sodium selenite which are not considered as 
additional macro-nutrients. A premix of vitamins, folic acid and 
niacinamide may also be added. Colorings and flavorings also may be added, 
as may vitamin C. The following example shows how the nutritional 
supplement beverage may be batch processed.

EXAMPLE I--THE INVENTION 
Batching/Processing (Lemon-Lime): 
1. 7026 kg water was placed in a blend tank. The water was heated to 
125.degree. F. (51.degree. C.) and 1080 kg of whey protein isolate was 
added and mixed until clear. 
2. The protein slurry was acidified by adding the selected acid system: 
a) 69 kg malic acid and 69 kg citric acid was dissolved in 300L water 
heated to 100.degree. F. (38.degree. C.). This solution was added to the 
protein slurry. 
b) 75 kg of 37% hydrochloric acid (HCl) was diluted in 150L of cold water 
and added to the protein slurry with good mixing. 
3. The protein/acid slurry was mixed until clear and then the pH 
(specification range 2.8-3.3) was adjusted (if required). 
4. The carbohydrate mixture was prepared by placing 11280 kg of water in a 
blend tank and heating to 175.degree. F. (80.degree. C.): 
a) 1565 kg sucrose and 4903 kg maltodextrin with a DE of 20 was added and 
mixed until clear. 
b) 5.732 kg of minerals and ultra trace mineral premix was added to 950L 
water at 150.degree. F. (66.degree. C.). 1.7 g sodium selenite and 5.3 g 
potassium iodide was added and mixed until clear. This solution was added 
to the carbohydrate blend. 
5. The carbohydrate/mineral slurry was added to the protein/acid slurry and 
blended for 5 minutes. 
6. The combined slurries were processed as follows: HTST at 165.degree. F. 
(74.degree. C.) with hold time of 16 seconds, cool to 40.degree. F. 
(4.4.degree. C.) and homogenize at 2500 psig (17,237 kPa). 
7. Pump finished product to storage tank. 
8. Standardize the processed batch as follows: 
a) Add 850 L water to a tank and heat to 100.degree. F. (38.degree. C.). 
Add 985 g water soluble premix, 341 g niacinamide and 25 g folic acid and 
mix. Add this water soluble premix to the finished product tank. 
b) Dilute 28.3 kg Lemon-Lime liquid color with 200L cold water and add to 
the finished product tank. 
c) Dilute 50.8 kg Lemon-Lime liquid flavor with 200L cold water and add to 
the finished product tank. 
9. Test completed blend for required parameters prior to release to-fill 
testing. 
10. Dissolve 4737 g ascorbic acid in cold water and add to finished product 
just prior to aseptic filling. 
Aseptic Processing and Filling: 
1. Transfer product from finished product storage tank to the balance tank. 
2. Homogenize at 400 psig (2758 kPa). 
3. Heat to 220.degree. F. (104.degree. C.) and hold for an average time of 
20 seconds. 
4. Cool to 70.degree. F. (21.1.degree. C.). 
5. Transfer to aseptic surge tank and aseptically fill a suitable container 
with the beverage. 
The nutritional supplement beverage produced in accordance with the present 
invention results in a clear, thin beverage which gives a refreshing mouth 
feel and is useful as a protein/carbohydrate nutritional supplement. These 
beverages also have the advantage of having relatively high caloric 
density (typically above 1.00 kcal/ml) and relatively high protein content 
(typically about 4.0 grams per liter). 
Table I presents a nutrient profile typical of those achieved in accordance 
with Example I. 
TABLE I 
______________________________________ 
Nutrient per 100 ml Range 
______________________________________ 
Protein (g) 3-5 
Carbohydrate (g) 20.0-30.0 
Energy Density (Kcal) 92-140 
Sodium (mg) 22.5-37.5 
Potassium (mg) 16.5-27.5 
Chloride (mg) 75-175 
Calcium (mg) 24-40 
Phosphorous (mg) 5-15 
Magnesium (mg) 4-10 
Iron (mg) 1.2-2.0 
Zinc (mg) 1.5-2.5 
Copper (mg) 0.14-0.23 
Manganese (mg) .30-.60 
Iodine (ug) 18-30 
Molybdenum (ug) 13-23 
Chromium (ug) 9-15 
Selenium (ug) 8-15 
Vitamin A (IU) 1000-2000 
Vitamin D (IU) 20-40 
Vitamin E (IU) .5-2.5 
Vitamin K (umg) 7.5-12.5 
Vitamin C (mg) 5-30 
Vitamin B1 (mg) 0.15-0.25 
Vitamin B2 (mg) 0.13-0.21 
Vitamin B6 (mg) 0.14-0.24 
Vitamin B12 (ug) 0.38-0.63 
Niacin (mg) 2.1-3.5 
Folic Acid (ug) 30-50 
Biotin (ug) 22.5-37.5 
Pantothenic Acid (mg) 0.3-0.5 
______________________________________ 
EXAMPLE II--COMATIVE 
The experiment was conducted to demonstrate that the use of a whey protein 
isolate is critical for attaining the goals of this invention. 3396 g of 
water was heated to 80.degree. F. (27.degree. C.) and 223 g of whey 
protein concentrate from New Zealand Milk Products, Inc. was added and 
mixed to form a slurry. Phosphoric acid was added to the slurry to reduce 
the pH to 3.6 and the mixture was heated to 175.degree. F. (80.degree. 
C.). 213 g of sucrose and 674 g of maltodextrin with a DE of 20 was then 
added and the mixture was stirred. The product was further processed in a 
usual manner. The resulting finished product was cloudy and yellow in 
color. The experiment demonstrates that use of a whey protein concentrate 
which contains fat and lactose is not suitable for the production of a 
clear beverage. 
EXAMPLE III--COMATIVE 
This experiment was conducted to demonstrate that a pH of 2.8 to 3.3 is 
critical for obtaining the goals of this invention. 3117 g of water was 
heated to 125.degree. F. (52.degree. C.) and 184 g of whey protein isolate 
(Proyon) was added and mixed until clear. The pH of the protein solution 
was adjusted by (1) adding 50% phosphoric acid to reduce the pH to 4.5 and 
then (2) 50% malic/citric acid was added to reduce the pH to 4.0. The 
mixture was heated to 165.degree. F. (74.degree. C.) and 178 g of sucrose 
and 878 g of maltodextrin was added and stirred. Vitamins, trace minerals 
and ultra-trace minerals were then added and the mixture was then 
processed in a usual manner. The resulting product was milky white in 
appearance and possessed a very thick texture or mouth feel. This 
experiment demonstrates that a pH of less than 4.0 is required to achieve 
the goals of this invention. 
EXAMPLE IV--COMATIVE 
This experiment was conducted to demonstrate that acidification of the 
protein slurry prior to mixing with the carbohydrate slurry is critical to 
obtaining the goals of this invention. More specifically, this experiment 
shows that acidification of a protein/carbohydrate slurry results in an 
unacceptable product. 
1397 g of water was heated to 125.degree. F. (52.degree. C.) and 184 g of 
whey protein isolate (Provon) was added and stirred until clear. In a 
separate vessel 857 g of water was heated to 175.degree. F. (80.degree. 
C.) and 275 g of sucrose and 868 g of maltodextrin and trace minerals and 
ultra-trace minerals were added and stirred until clear. The protein and 
carbohydrate slurries were then combined and stirred for 5 minutes. 121 g 
of malic acid and 12 g of citric acid were added to 50 g of water. The 
acid solution was then added to the protein/carbohydrate slurry. 13 g of 
37% hydrochloric acid was then added to the protein/carbohydrate slurry. 
The mixture was then processed in a usual manner. The resulting product 
was cloudy and possessed a slightly thick texture. 
This experiment demonstrates that acidification of the protein slurry prior 
to combination with the carbohydrate slurry is required to achieve a clear 
beverage that possesses a thin texture. 
Although the products may be fortified with additional major minerals or 
macro-nutrients (Ca, Mg, Cl, P, K, Na), it has been found that the 
addition of these minerals has an adverse effect on the product's textural 
and appearance properties. Accordingly, the products in the preferred 
embodiment of the present invention contain only those amounts of major 
minerals inherent to the raw materials used, (such as through the protein, 
carbohydrate and ingredient water). The products of the present invention 
may be fortified with trace and/or ultratrace minerals and/or vitamins 
without detrimental impact to the textural and appearance properties of 
the product. 
The nutritional supplement beverage of the present invention can be made in 
ready to consume form, in the form of a concentrate, a frozen sorbet or 
powder form and may be flavored with natural and/or artificial flavors 
and/or fruit juice concentrates. The beverage of this invention may also 
be carbonated. The nutritional beverage of the present invention, due to 
its thinness and clarity, was found to produce a refreshing, tart 
juice-like mouth feel at a significantly high caloric density (greater 
than 1.00 kcal/ml at 3-5% protein by wt.). 
The nutritional supplement beverage of the present invention may be 
packaged in accordance with materials and methods used in the packaging 
art. 
Industrial Applicability 
Some patients in need of nutritional supplementation simply do not like or 
cannot tolerate milky supplements. These patients may also suffer from 
taste fatigue which can hinder compliance. The product of this invention 
will offer malnourished patients a new variety of supplement that will 
improve intake and thereby improve nutritional status. The product of this 
invention provides a high level of energy and protein in a clear, 
juice-type supplement which will be found useful in the medical community. 
The product of this invention is intended to be used as a necessary 
nutritional supplement for patients with the following conditions: disease 
related malnutrition, short bowel syndrome; proven inflammatory bowel 
disease; bowel fistulae; pre-operative preparation of patients who are 
malnourished; treatment following total gastrectomy; dysphagia; and 
intractable malabsorption. 
In accordance with the foregoing disclosure, it will be within the ability 
of one skilled in the relevant arts to make modifications to the present 
invention, such as through the substitution of equivalent materials and/or 
their amounts, without departing from the spirit of the invention as 
reflected in the appended claims.