Method of controlling the release of carbohydrates by encapsulation and composition therefor

A composition of carbohydrates having an edible coating is disclosed, whereby the coated carbohydrate, when orally ingested, causes a time delay release of the carbohydrate into the digestive system. The method of administering carbohydrates in this manner may be useful in the treatment of diseases such as diabetes and exercise programs calling for sustained effort.

BACKGROUND OF THE INVENTION 
The present invention relates to a method for preparing a delayed release 
encapsulated carbohydrate composition in solid or liquid particulate form 
for use in snacks, candies and confections, dessert mixes, granola bars, 
energy bars, various beverages, shelf stable powders, ready to eat foods 
such as puddings, frozen yogurts, ice creams, frozen novelties; cereals, 
snacks, meal replacements, baked goods, pasta products, confections, 
military rations, specially formulated foods for children, and specialized 
gastric enteral feeding formulations. In addition to human foods, the 
invention is also useful in pet foods and animal feeds. 
In the preparation of various foodstuffs and other ingested items, such as 
vitamins, drugs and the like, such foodstuffs having been encapsulated to 
provide a delayed release flavor, medicinal action or the like. As stated 
above, the subject invention relates to an encapsulated and coated 
metabolizable carbohydrate composition which has a controlled release upon 
ingestion whereby the carbohydrates are slowly released into the body's 
digestive tract. This delayed release action can be very helpful in 
counteracting the effects of diseases, such as diabetes which is 
characterized by a raised glucose concentration in the blood due to a 
deficiency or diminished effectiveness of insulin. The disease is chronic 
and also affects the metabolism of fat and protein. In general, some cases 
can be controlled by diet alone while others require diet and insulin, and 
for still others control with drugs is needed. 
When controlling the effects of diabetes in humans and other mammals with 
diet, the diabetic is advised to control the timing of meals and snacks, 
control the composition of the food, and monitor the caloric content of 
the food. The diabetic who eats a high-calorie, high-carbohydrate meal 
will experience elevated blood glucose levels one-half to one hour after 
ingestion. To minimize this effect, a physician normally counsels his 
patient to distribute the carbohydrate load over several spaced snacks and 
meal occasions. A non-diabetic person could eat a high 
carbohydrate/caloric meal and the carefully modulated insulin response of 
his body will maintain the blood glucose levels within normal ranges of 
70-120 mg/dl. A diabetic who has impaired insulin metabolic controls has 
to rely on external control mechanisms, i.e., the timing of meals, the 
composition of the meals, and the caloric density of the meals. For the 
more severe cases of diabetes, drugs have been developed which modulate 
the blood glucose response by interfering with the enzymes which break 
down starch or sugar in the upper G.I. tract. The effect is to prolong the 
digestion and absorption of glucose as food traverses the G.I. tract. 
Other reasons exist for modulating the blood glucose response, such as the 
demands of exercise, nutrition, weight control, strenuous working 
conditions, and the like. 
SUMMARY OF THE INVENTION 
Therefore, an object of the subject invention is an encapsulated 
carbohydrate composition which causes a timed delay release of the 
carbohydrates in the digestive tract of the human body. 
Another object of the subject invention is a shelf-stable powder, 
granulation or agglomeration, capable of being stabilized and suspended in 
a liquid medium for easier dispersion and a timed release into the 
digestive tract of the human body. 
Another object of the subject invention is a preparation of an 
encapsulated, insoluble carbohydrate which is stable in a liquid 
environment and is released by the conditions in the digestive system--pH, 
moisture, enzymes. 
A further object of the subject invention is a method of encapsulating 
metabolizable carbohydrates as a time-delay mechanism for ingestion and 
digestion by a subject in a controlled manner. 
These and other objects are obtained by the subject invention wherein the 
release of carbohydrates to the absorption sites in a G.I. tract of a 
human or animal, is controlled by encapsulating the desired metabolizable 
solid or liquid carbohydrate (starch, glucose, sucrose, fructose, etc.) in 
a food or pharmaceutical grade coating. As the encapsulated particle, 
granulation, or agglomerate moves down the digestive tract, the coating 
degrades and slowly releases the carbohydrate. Thus, by coating the food 
particle, absorption in the upper G.I. tract could be experienced over a 
one-half to four-hour time period which would help modulate the blood 
glucose levels and possibly eliminate or reduce the need for a diabetic to 
snack between meals. 
In the method of the subject invention, the carbohydrate may be 
spray-coated in a coating pan or in a fluidized bed, or coated directly on 
a rotating disc, all in a manner which provides a substantially equal 
distribution of the coating on the carbohydrate. It is not necessary that 
the coating film be equally distributed on the particle, but will depend 
on the particle itself and the use. Both liquid and solid carbohydrates 
may be coated by use of appropriate coating techniques. The coated 
particle is then administered.

DESCRIPTION OF THE PREFERRED EMBODIMENTS 
In the method of the subject invention, metabolizable carbohydrates such as 
sucrose, glucose, lactose, dextrins, raw starches, modified starches, 
pregelatinized starches, fructose, maltose and other mono, di, oligo, and 
polysaccharides which are normally absorbed and metabolized in the 
digestive tract may be coated with a food or pharmaceutical grade coating 
such as stearic acid, hydrogenated or partially hydrogenated oils, such as 
cottonseed, soybean or rape seed oil, calcium stearate, stearyl alcohol, 
candelilla wax, food grade shellac, hydrocolloids such as CMC, gum arabic, 
carrageen, gellan, alginates, gelatin, xanthan, pectins, methyl cellulose 
and the like. The coating may be from any of various processes, including 
coating in a coating pan, spraying, fluidized bed, or utilizing the 
rotating disc method such as disclosed in U.S. Pat. Nos. 5,100,592 and 
4,675,140. Other methods such as edible film formation, multi-layer 
emulsions, co-extrusion emulsions, dispersions, granulation/drying, 
coacervation, and forming/cooling may be used to form the particle. 
In the method of the subject invention, the carbohydrate is coated so as to 
experience controlled, delayed absorption when ingested into the human 
body. The coated product should result in a shelf-stable powder with 
particle size range of 30 to 1,000 .mu.m. The actual size of the particle 
would depend both on dissolution rates desired and organoleptic 
characteristics of the food system in which it is administered. The 
particle could also be prepared as an agglomerate of individual particles 
to improve dispersion. In general, where a smoother textured food is 
required, such as beverages, a finer particle size range (75-150 .mu.m) 
would be utilized. For food systems where the food is masticated, larger 
sized particles could be used (+150 .mu.m). Because the active component 
is encapsulated by the method of the subject invention, the resulting 
coated particles would be relatively inert and bland in both aroma and 
taste. This would allow the coated particle of the subject invention to be 
incorporated in a variety of foods without affecting the characteristic 
properties and flavors of the food. 
The coating set forth above could be selected to be compatible with the 
components and preparation of the food. For instance, ethyl cellulose, a 
non-food ingredient, could be selected for foods containing free fats or 
oils and elevated preparation temperatures of up to 100.degree. C. 
Hydrogenated tallow and stearic acid coatings would be suitable where 
temperatures do not exceed 60.degree. C. and significant quantities of 
free lipids are not present. 
In the following example, several methods of coating carbohydrates are set 
forth where the in vitro release rates of some of the products which have 
been obtained by such coating, are shown. 
EXAMPLE 1 
Coating of Glucose with Stearic Acid in a Coating Pan 
D-glucose was sieved to obtain 250 g of a fraction which passed through a 
300 .mu.m sieve but was retained by a 177 .mu.m sieve. This was placed 
into the coating pan such as is commonly used in the pharmaceutical 
industry to coat tablets. In order to have a sufficient amount of material 
in the pan for proper mixing and coating, it was found necessary to add 
another solid which was of a larger size so that after coating, it could 
be separated from the glucose. Approximately 500 g table salt of about 420 
to 500 .mu.m was used for this purpose. Stearic acid, 375 g, was dissolved 
in 1875 ml of hot (75.degree. C.) ethanol. 
The pan was set to rotate 50 to 55 RPM. A two-fluid nozzle was connected to 
a hot air supply which was regulated between 15 to 22 psi. The ethanol 
solution was supplied to the liquid side of the nozzle at a rate of about 
10 ml/min. Room temperature air was blown into the pan to help evaporate 
the ethanol. Samples were removed from the pan after 20, 30, 40 and 50 
parts of stearic acid had been sprayed per 100 parts of solids being 
coated in the pan. 
After 50 parts were sprayed, the solids were separated by sieving. The 
fraction 75 to 420 .mu.m was tested except for the highest level of 
coating where the fraction of 180 to 300 .mu.m was also tested. To test 
the release, 2 g of the coated sample was shaken in 100 ml of water in a 
250 ml plastic bottle (approximately 1 inch travel 60 cycles/min). 
Periodically, approximately 3 ml of the solution was withdrawn and the 
concentration determined by measuring the refractive index of the solution 
relative to that of pure water (differential refractive index). After the 
measurement, the solution was returned to the bottle. After 1 day, the 
particles were filtered out of the solution and crushed with a mortar and 
pestle. The crushed particles were combined with the solution and 
concentration was measured again. This represents the concentration 
corresponding to 100% of the glucose released. To obtain the percent 
glucose release, the glucose concentration in the solution at any time was 
divided by the concentration corresponding to 100% released. The loading 
was calculated by dividing the concentration corresponding to the 100% of 
the glucose released by the concentration corresponding to 2 g uncoated 
glucose in 100 ml. 
FIG. 1 shows the percentage of glucose released from the particles of 
Example 1 versus time. It may be seen that when the amount of coating 
increases, the rate of release is decreased. And that the time scale may 
be adjusted to release the glucose in a time corresponding to the 
residence time in the gastro-intestinal tract by suitable adjustments in 
the process. 
EXAMPLE 2 
Coating on a Rotating Disc With Solutions of Polymers 
The rotating disc allows rapid coating of particles. Approximately 100 g 
glucose passing a 125 .mu.m 8 sieve but being retained by a 75 .mu.m sieve 
were slurried into 200 ml solution of acetone 4 parts to 1 part of ethanol 
containing 7.5% w/v ethyl cellulose and immediately poured into the 
central opening of a rotating vaned disc (8 inches in diameter with 24 
vanes) rotating at 10,000 RPM. The particles were dry and were immediately 
collected. When tested for release, the 75 to 300 .mu.m fraction which had 
a payload of 89% (11% coating) corresponding to an average wall thickness 
of 9.6 .mu.m released 82% of its glucose concentration in 5 minutes and 
97% in 20 minutes. This coating thus shows only slight protection and 
would not be sufficient on its own but may serve as a prime coat. A second 
coat is a hot melt coat containing tristearin, which is applied by 
spraying from solution. Other fats and fat-like substances, including 
triglycerides such as tristearin, tripalmitin, trilaurin or glyceryl 
behenate or mixtures thereof, diglycerides and monoglycerides as well as 
free paraffin wax, bees wax, carnauba wax, and microcrystalline waxes 
allowed as part of food or drug components. Proteins may also be utilized 
as a second coating and may be egg albumin, casein, zein, or soy proteins. 
Semi-synthetic polymers may also be used and include ethyl cellulose, 
cellulose acetate phthalate, hydroxypropyl methyl cellulose phthalate. 
Synthetic polymers also are possible for use as a second coating and 
include acrylate copolymers approved for coating of medical forms for oral 
ingestion. Application of these materials may generally be accomplished by 
spraying from solution, dispersion or emulsion, as appropriate. 
EXAMPLE 3 
Coating on the Rotating Disc With an Edible Hot Melt 
A hot melt was prepared as follows: 26 g stearic acid was melted and heated 
to 150.degree. C. 10.5 g ethyl cellulose (7 cps) was dissolved in it. 103 
g hydrogenated tallow was added and the liquid brought to about 85.degree. 
C. 70 g of the product from Example 2 passing a 150 .mu.m sieve but being 
retained by a 75 .mu.m sieve was added to the melt and stirred in to make 
a homogeneous mixture. The rotating disc used in Example 2 was heated to 
80.degree. C. and turned on to rotate at 10,000 RPM and the slurry poured 
into the opening of the disc at the rate of about 300 ml/min. Two 
fractions which represented together 83% of the product were tested 75 to 
150 .mu.m and 150 to 300 .mu.m. The payload was 34 and 44% respectively. 
In 5 minutes, the release rate was 51.4 and 20.5%, in 20 minutes 61.2 and 
34.7% was released, in 80 minutes, 74.3 and 65.6% was released. After 5 
hours, 81% of both fractions were released. 
EXAMPLE 4 
Coating of Glucose in a Fluidized Bed With a Solution of Ethyl Cellulose 
750 g anhydrous glucose, passing a 300 .mu.m screen but being retained by a 
177 .mu.m screen was placed in a fluidized bed (6 inch diameter) where it 
was fluidized with air from below. Ethyl cellulose was dissolved in 
acetone ethanol 4/1 by volume to make a 3% w/v solution. The solution was 
sprayed with a two-fluid nozzle using air at an air pressure of 25 psi and 
a liquid rate of about 8 ml/min. It was sprayed on until 5.4% of coating 
was deposited. The 75 to 300 .mu.m fraction was tested. 46.8% was released 
in 5 minutes, 72.6% was released in 20 minutes, 91% was released in 80 
minutes. 
EXAMPLE 5 
Coating of Fructose in a Coating Pan with Stearic Acid 
Fructose was sieved to remove particles smaller than 420 .mu.m. 650 g of 
this was placed in the apparatus described in Example 1 and coated with 
stearic acid by spraying a 20% w/v solution in ethanol as in Example 1. A 
sample removed from the run had a payload or glucose content of 75.9%. In 
the standard release test, it released 45.1% in 10 minutes, 48.2% in 1 
hour, 64% in 3 hours, 91% in 19 hours. 
EXAMPLE 6 
Coating Corn Starch With Hydrogenated Tallow on the Rotating Disc 
40 g stearic acid (Witco Hystrene 9718) was melted and heated to 
135.degree. C. 20 g ethyl cellulose (Dow, Ethocel of 7) was dissolved in 
it. Then 140 g of hydrogenated tallow (Kraft) was added and dissolved. 100 
g corn starch Mira-Gel 463 (Staley) was dispersed in the melt and sprayed 
with an 8-inch diameter vaned disc at 10,000 RPM. 245 g of product was 
collected. 
The particles of product ranged from about 30 to 300 .mu.m in size. The 
original starch granules are about 15 .mu.m; therefore, several of the 
granules make up a product particle glued together by the hot melt. 
To determine the active content, the product was ground with a mortar and 
pestle and 1 g placed into cellophane tubing with a, 6000 molecular weight 
cut-off. Also into the tube was placed 30 ml water 0.05 ml BAN 120L 
amylase, 6 units (Novo Nordisk) and 2 ml AGM 200 L amyloglucosidase 400 
units (Novo Nordisk). 1 unit of amylase breaks down 5.25 g of soluble 
starch per hour at 37.degree. C. and Ph 5.6. 1 unit of amyloglucosidases 
hydrolyses 1 micromole of maltose per minute at 25.degree. C. and Ph 4.3. 
The ends of the cellophane were tied, and formed into a U-shape and 
immersed into 300 ml of acetate buffer of Ph 4.5. The buffer was stirred 
with a magnetic stirrer and thermostatted at 37.degree. C. 5 ml samples 
were taken from the buffer after 12, 24, and 48 hours, frozen and analyzed 
with the Hitachi 747 glucose hexokinase method. A calibration with glucose 
in the presence of the enzyme is necessary. The amount of glucose 
liberated from this sample was 49% of that of the uncoated Mira-Gel and 
did not change appreciably after 12 hours. 
To determine the rate of available glucose in a simple simulated digestion, 
we proceeded as above, except 821 mg of unground product containing 403 mg 
of starch was used. The buffer was sampled at 20 minutes, 1 hour, 4 hours 
and 8 hours after the start of the experiment. The samples were frozen and 
later analyzed. The coated Mira-Gel starch showed the following release: 
______________________________________ 
Time Coated Starch 
______________________________________ 
20 minutes 14% 
1 hour 32% 
4 hours 72% 
______________________________________ 
Controlled release of carbohydrates from raw, modified or pre-gelatinized 
starch granules derived from other starchy foods would also be achievable 
by the above encapsulation methods. 
This would include starches obtained from cereals, such as wheat and rice, 
and from starches obtained from root crops, such as potato and tapioca. 
Diabetes patients who are taking insulin or oral hypoglycemic drugs are 
prone to low blood sugar reactions especially during or after exercise or 
increased activity. Low blood sugar or hypoglycemia is defined as a blood 
glucose level below 50 mg/dl and is potentially a very serious, acute 
complication of diabetes. A normal blood sugar range is generally 70 to 
120 mg/dl. Symptoms of hypoglycemia range from shakiness, light-headedness 
and tachycardia to headache, blurred vision, poor coordination and 
eventually to loss of consciousness and death. There are two main 
counter-regulatory hormones that help the body recover from hypoglycemia: 
glucagon and epinephrine. Decreased hormone secretion in people who have 
had diabetes for several years can cause more frequent low blood sugar 
reactions and more difficulty in noticing that blood sugar is low. 
To exercise safely, diabetics often have to increase food intake either 
before, during or after exercise. Exercise of moderate intensity (doubles 
tennis, leisurely biking, golfing) requires about 10 to 15 grams of 
carbohydrates per hour of exercise. One to two hours of strenuous activity 
may require 25 to 50 grams of additional carbohydrates. A beverage or 
snack bar with controlled release carbohydrates lends itself to preventing 
low blood sugar during and after exercise. 
Controlled release carbohydrates (CRC) may be described as a shelf-stable 
powder with a particle size range of 30-1000 .mu.m. Products in which a 
smooth, non-gritty texture was desired would utilize the finer particle 
size range. Products which are granular or have large particles could 
utilize the larger particle size range. 
When the active components are encapsulated according to the subject 
invention, CRC powders are relatively inert and bland in both aroma and 
taste. This will allow CRC to be incorporated in a variety of foods 
without affecting the characteristic properties and flavor of food. 
Alternatively, colorants and flavors can be added to coatings to improve 
consumer acceptance. Emulsifiers can be incorporated as part of coating to 
aid in dispersion in the food system. 
CRC powders in which the carbohydrate is readily water soluble releases its 
load by a diffusion process as it transits the digestive system. 
Therefore, these products would have to be prepared by mixing in a liquid 
system or a viscous food system, e.g., yogurt, and consumed 5-15 minutes 
after preparation. 
CRC powders may be prepared in which the carbohydrate is a raw, 
pre-gelatinized, or modified starch. The carbohydrate load would be 
released by hydration, swelling and reaction with the digestive amylases. 
Hence, CRC powders based on starch granules would have extended stability 
in liquid systems. This would extend the food application to RTE foods 
(puddings, yogurts, frozen novelties) and ready to drink beverages. 
CRC powders may be added to food products which are low in water 
activity--dry beverages, nutritional beverage powders, dessert mixes. 
Product would be prepared according to recipe and consumed. 
CRC powders may be used as a sole source of carbohydrates in the food or in 
combination with uncoated rapidly absorbed carbohydrates. 
CRC powders are designed to release the bulk of their carbohydrate payload 
within approximately four hours after ingesting. Release times 
significantly longer than four hours would incur the release of excessive 
carbohydrates in to the large intestine. This would affect the osmotic 
water balance and increase the risk of bacterial fermentation leading to 
increased gas formation and laxation. 
Calculation of Caloric Delivery for CRC Materials 
CRC products may be produced by coating glucose granules with stearic acid 
as in Example 1. Glucose payload should be approximately 75% and coating 
thickness should be adjusted to give 80% release within 1-4 hours after 
ingestion. 
Based on the above parameters, each 100 kcal of energy from glucose 
released would require 41.7 g of material. 
Calculation 
100 Kcal/4 Kcal per gram glucose =25.0 g glucose 
25 g/0.75 payload delivery =33.3 g CRC at 100% release 
33.3 g/0.80 release factor =41.7 g CRC at 80% release 
The carbohydrate load and release rate can be adjusted to individual 
nutritional needs and product application. 
Examples of different caloric deliveries using the above example are listed 
below: 
Product Applications for Controlled Release Carbohydrates (CHO) 
1. 25.0 g CRC delivers 15 g CHO and 60 kcal energy. 
2. 41.7 g CRC delivers 25 g CHO and 100 kcal energy. 
3. 50.0 g CRC delivers 30 g CHO and 120 kcal energy. 
Nine ounces of prepared beverage is formulated to provide 22 g of readily 
absorbable, uncoated carbohydrates plus 30 g of controlled release 
carbohydrates. The CRC material is encapsulated to release as follows: 
______________________________________ 
Time CHO Released Calories Total Calories 
______________________________________ 
Start exercise 
22 g 88 88 
60 minutes 
15 g 60 148 
120 minutes 
15 g 60 208 
______________________________________ 
This controlled release beverage would support two hours of strenuous 
exercise. If a diabetic wants to support three hours of moderate exercise, 
such as a round of golf, he or she would only drink 6 ounces of beverage. 
This would provide: 
______________________________________ 
Time CHO Released Calories Total Calories 
______________________________________ 
Start exercise 
15 g 60 60 
60 minutes 
10 g 40 100 
120 minutes 
10 g 40 140 
______________________________________ 
While there will always be individual differences between people, this 
product would generally enable the diabetic exerciser to maintain a blood 
sugar level between and 180 mg/dl, providing they start in this range. 
By incorporating CRC into a snack bar similar to an "energy bar" or 
"granola bar," similar release rates could be obtained. Although there may 
be a limited amount of CRC granules crushed through chewing, the bulk will 
be ingested intact as part of the swallowed bolus. The quantity of readily 
absorbable carbohydrate released by chewing would be factored into the 
requirements for the calories required at the start of exercise. 
The caloric load in a 9 oz. beverage sample could be incorporated in a 
single bar scored into 3 parts. For two hours of strenuous exercise, the 
subject eats the whole bar. For three hours of moderate exercise, the 
subject eats two of the three parts, with additional carbohydrate left for 
future consumption. Alternatively, the carbohydrate load might be 
delivered in 3 separate smaller bars. 
Hypoglycemia can be a serious problem for a diabetic during the 
night--usually around 3 a.m. A bedtime beverage which is taken 1/2 hour 
before sleep should be formulated to provide 15 g of uncoated 
carbohydrates for normal absorption and 15 grams of CRC for slow release. 
______________________________________ 
Time CHO Released Calories Total Calories 
______________________________________ 
Start sleep 
15 g 60 60 
60 minutes 
5 g 20 80 
120 minutes 
5 g 20 100 
180 minutes 
5 g 20 120 
______________________________________ 
The above regimen will prevent a significant fall in blood glucose during 
the night for those who have exercised vigorously during the day and are 
at risk of hypoglycemia for up to 30 hours after the exercise. If the 
blood sugar is well controlled, the overnight blood sugar will remain 
within the acceptable range of 70-140 mg/dl. Individual variations exist 
and release curves and levels would be adjusted based on individual 
medical needs. 
The product made with CRC may contain other nutrients, e.g., fiber, 
vitamins, and minerals to provide additional nutritional benefits. 
EXAMPLE 7 
Artificially sweetened powdered soft drink with 42 grams coated glucose in 
8 oz of beverage. 
______________________________________ 
Amount % 
______________________________________ 
Coated glucose from Example 1 
42.00 g* 
Guar gum .40 (.10-.60) 
Aspartame .04 (.02-.10) 
Citric acid .30 (.10-.60) 
Trisodium citrate .26 (.15-.40) 
Dried citrus flavor .24 (.05-4.0) 
Red #40 .01 (.005-.15) 
Polysorbate .01 (.005-.03) 
43.26 g 
______________________________________ 
*100 kcal from glucose 25 grams glucose 
Add powder to 8 fl. oz. of cold water and shake or stir thoroughly and 
drink. 
Using the above example, uncoated sugars such as fructose, glucose or 
sucrose could be added to deliver a portion (10-50%) of the caloric 
requirements and the level of coated glucose decreased correspondingly. 
EXAMPLE 
______________________________________ 
Amount % 
______________________________________ 
Coated glucose of Example 1 
21.00 g* 
Fine Granular Glucose 
22.00 (5.0-50.) 
Guar Gum .40 (.10-.60) 
Aspartame .04 (.02-.10) 
Citric acid .30 (.10-.60) 
Trisodium citrate .26 (.15-.40) 
Dried citrus flavor .24 (.05-4.0) 
Red #40 .01 (.005-.15) 
Polysorbate .01 (.005-0.3) 
44.26 g 
______________________________________ 
Formula delivers 12.6 g of carbohydrate from CRC and 22 g of carbohydrate 
from glucose. 
EXAMPLE 9 
______________________________________ 
Instant chocolate pudding 
Amount % 
______________________________________ 
Coated fructose of Example 5 
42.00 g 
Pregel. corn starch 18.35 (12-24) 
Monopotassium phosphate 
1.80 (1.4-2.2) 
Tetrapotassium pyrophosphate 
1.80 (1.4-2.2) 
Mono and diglycerides 
.70 (.4-1.0) 
Cocoa powder 12.00 (8.0-16.0) 
Aspartame .28 (.2-.4) 
Vanilla flavor .07 (.01-1.4) 
77.00 g 
______________________________________ 
Recipe 
Pour mix into bowl. Add 2 cups cold skim milk and blend for 2-3 minutes 
with beater. Pour into serving cups. Chill. Makes four 1/2 cup servings. 
EXAMPLE 10 
______________________________________ 
Snack Bar Amount % 
______________________________________ 
CRC Example 1 25.00 g (5.0-50.) 
Glucose 7.00 (4.0-10.) 
Granola cereal 8.75 (4.0-10.) 
Vegetable 2.00 (1.0-4.0) 
Glycerine 1.50 (0.5-3.0) 
Water 1.00 (0.5-3.0) 
Sweet whey 1.00 (0.2-2.0) 
Lecithin .15 (0.5-.30) 
Cinnamon .15 (0.5-.30) 
Flavoring .10 (.02-.20) 
46.65 g 
______________________________________ 
Formula delivers 15 g carbohydrate from CRC and 15 g untreated 
carbohydrates from glucose and the granola cereal blend (rolled oats, 
wheat, glucose syrup). 
EXAMPLE 
______________________________________ 
Amount % 
______________________________________ 
CRC (Ethyl cellulose coating 
25.00 g (5-40) 
15 g carbohydrate) 
Sucrose 25.00 (15-35) 
Chocolate liquor 28.20 (10-35) 
Cocoa butter 21.00 (10-35) 
Lecithin .50 (0.2-1.0) 
Natural Flavor .30 (0.1-0.6) 
100.00 g 
______________________________________ 
Formula delivers 15 g carbohydrate from CRC and 33 g carbohydrate from 
sucrose and chocolate liquor. 
EXAMPLE 12 
Breakfast Cereals--Instant Oat Meal 
Breakfast cereals provide a significant amount of carbohydrate per serving. 
A one ounce (28 g) serving of unsweetened corn flakes provides 24 grams of 
carbohydrate or 8% of the daily value. Sugar sweetened corn flakes would 
provide slightly more carbohydrates, 26 g, because of the added sugar. 
Clinical and psychological studies have indicated that mental and physical 
skills are enhanced if blood glucose levels can be optimized and mild or 
reactive hypoglycemia can be avoided. 
CRC incorporated into cereals provides sustained carbohydrate release which 
would maintain glucose levels over a 1-4 hour time period. In addition to 
improving performance skills, maintaining blood glucose levels between 
meals has an appetite suppressant effect which could be of value in weight 
loss and control regimens. 
Targeting 50% of total carbohydrate per serving derived from CRC, the 
following levels would be added to an oatmeal formulation. 
______________________________________ 
Total 
Ingredient percent per/28 g % CHO CHO 
______________________________________ 
Instant Rolled 
50% 13.9 g 72.30 10.1 
oats g 
CRC 50% 14.1 g 71.25 10.0 
Core CHO 75% 
Release 95% 
100% 28.0 g 20.1 
g 
______________________________________ 
The amount of carbohydrates delivered from CRC could be varied from 5-50% 
by changing the ratios of the oats and CRC. The composition can be 
flavored with salt, spices, and other flavorants. If additional sweetness 
is desired, intense sweeteners such as aspartame, ace-K, sucralose could 
be added. CRC could be added to the oat cereal by simply mixing CRC powder 
into the dried oat blend before packaging. 
Encapsulating materials such as methyl cellulose or food grade waxes would 
be preferred coatings for more soluble carbohydrate cores such as glucose, 
sucrose, lower weight maltodextrins, etc. To provide increased heat and 
moisture stability, less soluble carbohydrate cores, such as starch, 
higher molecular weight dextrins, carbohydrate polymers, etc., would be 
preferable. 
CRC technology can be adapted to a wide range of grain based hot 
cereals--oats, farina, wheat, rice and corn. For cereals which are 
consumed cold and which are formed by cooking extrusion, baking, puffing, 
or flaking processes, CRC would be added in a post processing and before 
packaging. This could be accomplished by spraying the formed cereal with 
an adhesive mixture of sugar syrup, adhesive edible gums or the like, and 
coating the CRC onto the surface in a coating reel or coating drum as is 
current industry practice to adhere particulates such as nuts, flavors or 
vitamins and minerals. 
In addition to grain based cereals, baked goods, such as breads, rolls, 
sweet doughs, biscuits, donuts, pies, pastries, cake, and cookies could be 
fortified with CRC to provide sustained energy. As with cereal 
applications, the selection of the core and coating or encapsulating 
material would be tailored to the processing conditions and consumption 
usage. 
CRC also lends itself to the development of enhanced energy military 
rations to extend physical performance. CRC could be incorporated into 
field and combat rations to provide sustained energy for military 
personnel under conditions of extreme physical exertion. 
CRC could be incorporated into food, snacks and candies designed for 
children. CRC could slow down or modulate the release of the sugar after 
ingestion, preventing a "sugar high". and also providing sustained energy 
for the child between meals, 
CRC would also be of benefit in meal replacements products such as instant 
breakfast powders and ready to drink breakfast meal replacements. A 
portion of the carbohydrates would be encapsulated to provide sustained 
energy release. 
Hospital patients often require supplemental enteral feedings (tube 
feedings) to obtain proper nutrition. The use of high concentrations of 
simple sugars in the liquid formula can lead to complications in diabetic 
patients. A high level of soluble sugars in the formula would have an 
irritating effect on the gastric lining of patients receiving the food due 
to its high osmolality. CRC incorporated as part of the feeding formula 
would release soluble sugars after the food or liquid has left the 
stomach. Adverse osmolality effects would be greatly reduced. The diabetic 
patient would also benefit from the extended release profiles (1-4 hours) 
which would help modulate blood glucose levels. 
In addition a pet food could utilize the coated carbohydrate of the subject 
invention. A suitable formula for dry dog food is as follows: 
EXAMPLE 
______________________________________ 
% Fat (White) 
Coated Glucose 
% Red Meat Colored % Total 
From Example 1 
Color Base Marbling Formula 
______________________________________ 
Coated Glucose From 
29.17 29.41 29.22 
Example 1 
Collagen 17.48 17.45 17.48 
Soy Protein 11.49 16.45 12.48 
Concentrate 
Meat By-Product 
6.99 6.98 6.99 
Sorbitol 5.99 5.98 5.99 
Propylene Glycol 
5.99 5.98 5.99 
Meat & Bone Meal 
5.00 -- 4.00 
Dicalcium Phosphate 
4.57 4.89 4.63 
Dihydrate 
Animal Fat 3.48 3.49 3.48 
Sodium Chloride 
1.00 1.00 .99 
Vitamin-Mineral Mix 
.60 -- .48 
Potassium Chloride 
.50 .50 .50 
Potassium Sorbate 
.10 -- .08 
FD&C Red No. 40 
.01 -- .01 
Titanium Dioxide 
-- .30 .06 
Water 7.62 7.58 7.61 
______________________________________ 
Two doughes are prepares with the above ingredients. 
Each dough is processed separately in the following manner. The dry 
ingredients are added to a 200-lb. Ribbon Mixer and mixed for 1 minute. A 
400-lb. Sigma Blade Mixer may be used as well. The wet ingredients are 
combined in a meat tub, hot water added and mixed by hand allowing for at 
least partial melting of the fat. This mixture is then poured onto the dry 
mix in the mixer with the mixer on and blended for three minutes. The mix 
was then hand-fed into a screw extruder. 
The red dough is extruded at a rate capable of producing 300-lbs./hour 
while the white dough is extruded at a rate capable of producing 150-200 
lbs./hour. The temperature is maintained at 240.degree.-245.degree. F. in 
both the extruder and the die. 
The combined dough is then discharged onto an air cooled conveyor. Any 
conveyor system such as water cooled conveyors, may be utilized within the 
scope of the present invention. The speed of the belt is adjusted so as to 
obtain a steady stream of extrudate on the belt. A speed setting of 12 
feet per minute is used to produce the product of the present example. 
The product is then cooled and cut into bite size pieces. The product has a 
soft, marbled meat appearance which is firm, non-sticky and temperature 
stable. 
The coated glucose made possible the controlled delayed release of glucose 
into the dog's digestive tract, which may be used to control the intake of 
sugars and other carbohydrates by the dog and other mammals in the 
treatment of a diabetic condition. 
While the invention has been described with reference to a preferred 
embodiment, it will be understood by those skilled in the art that various 
changes may be made and equivalents may be substituted for elements 
thereof without departing from the scope of the invention. In addition, 
many modifications may be made to adapt a particular situation or material 
to the teachings of the invention without departing from the essential 
scope thereof. Therefore, it is intended that the invention not be limited 
to the particular embodiment disclosed as the best mode contemplated for 
carrying out this invention, but that the invention will include all 
embodiments and equivalents falling within the scope of the appended 
claims. 
Various features of the invention are set forth in the following claims.