WO2003024403A2

WO2003024403A2 - Carbohydrate supplementation and rehydration composition

Info

Publication number: WO2003024403A2
Application number: PCT/US2002/029594
Authority: WO
Inventors: Stephen J. Turner; Michael Patrick Hite; Catherine Federici
Original assignee: Nutraceutix Inc
Current assignee: Scolr Pharma Inc
Priority date: 2001-09-17
Filing date: 2002-09-17
Publication date: 2003-03-27
Anticipated expiration: 2004-03-17
Also published as: WO2003024403A3; AU2002336596A1

Abstract

A rehydration fluid comprising long chain glucose polymers having at least 5 repeating glucose units, simple sugars and electrolytes, and having an osmolality of less than about 250 mOSm/kg.

Description

CARBOHYDRATE SUPPLEMENTATION AND REHYDRATION COMPOSITION

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation in part of prior copending application Serial Number 60/323,192, filed September 17, 2001, the benefit of the filing date of which is hereby claimed under 35 USC 119.

FIELD OF THE INVENTION The present invention relates to a rehydration fluid, and more particularly to a rehydration fluid having improved osmolality and caloric properties. BACKGROUND OF THE INVENTION

Carbohydrate delivery and fluid replacement have become important issues for all athletes in sports, especially in endurance sports and also to others interested in recovery and rehydration such as patients recovering from illness, diarrhea, or surgery. In the case of athletes, carbohydrates are needed for pre-event loading, during-event supplementation, and post-event recovery. Fluid replacement is also a primary concern for any endurance athlete during athletic events. During an event, a large amount of water is lost through sweat and respiration. If this water is not replaced, the core body temperature will rise and performance will decrease. Fluids are also needed pre-event and post-event to help with carbohydrate assimilation and storage. Thus, a carbohydrate source used during an event should provide sufficient energy to enhance performance or replace expended energy without retarding fluid replacement or causing gastrointestinal distress.

Gastric transit time is the main concern for delivering water, beneficial electrolytes, supplements and carbohydrates to the athlete during an event. Solutions with high osmolalities can retard gastric transit time and therefore reduce or retard absorption of fluids, carbohydrates and electrolytes. Carbohydrates and electrolytes are better utilized in the intestinal tract versus the stomach. Shorter gastric transit times allow substances to quickly pass through the stomach and to be absorbed through the intestinal tract. Therefore, the effect of the osmolality of a fluid on the gastric transit time of the user impacts the absorption of carbohydrates, supplements and fluids before, during and after prolonged strenuous activity. Osmolality is a measurement of the number of particles, whether molecular or macroscopic, in a solvent. The total number of particles completely in solution dictates the osmolality of that solution. The levels of carbohydrate and other beneficial materials incorporated into a rehydration fluid directly impact the osmolality of the rehydration fluid, and thus affect the gastric transit time. Solutions with high osmolality retard the gastric transit time and thereby retard fluid absorption and carbohydrate utilization. Slower gastric emptying also leads to larger gastric residues, which can cause gastrointestinal distress. When residues exist within the stomach, cramping and gastric upset are common. In general, the higher the levels of carbohydrate in the rehydration fluid, the higher the osmolality, the greater the retardation of the gastric transit time, and the greater the retardation of fluid absorption. However, lowering the levels of carbohydrate may result in undesirable taste and/or insufficient energy supplies being delivered to the individual.

The osmolality of a solution is inversely proportional to the chemical potential (energy) of that solution. The difference in chemical potential (energy) between two solutions separated by a semipermeable membrane is called the osmotic pressure. Osmosis is the term used to explain the fact that solutions with a higher potential energy flow towards the solutions of lower potential energy when separated by a semipermeable membrane. Pure deionized water has an osmolality of zero and a chemical potential of 1 by definition. Water with dissolved particles has an osmolality greater than zero and a chemical potential less than 1. If a semi-permeable membrane, such as the lining in a digestive tract, separated these two solutions, there would be an osmotic pressure pushing towards the solution with the dissolved particles. This pressure differential is caused by the fact that the pure water has a higher chemical potential (energy) than the solution with dissolved particles. Osmotic pressure drives water from areas of low osmolality to areas of high osmolality or from areas of high to low potential energy. A solution with a large amount of material in it (high osmolality) has diluted the energy (chemical potential). The more particulate you add, the higher the osmolality, and the more dilute the energy, the lower the chemical potential. Recovery is the consumption of carbohydrate and liquids to replace glycogen and fluids lost during exercise or stress. Fructose is important for recovery in that it primarily replenishes liver glycogen stores whereas glucose polymers primarily replace muscle glycogen. Glycogen is the main source of energy for athletes competing in endurance events. Muscle glycogen is used to support muscle activity whereas liver glycogen is used to maintain blood glucose levels. Blood glucose supports brain function and also supplements the energy muscle glycogen provides to the muscles. Fructose is a beneficial carbohydrate due to its ability to provide carbohydrate to the liver for liver glycogen building. Liver glycogen is the main endogenous source of glucose used to maintain blood glucose levels. If blood glucose levels drop, hypoglycemic symptoms, including nausea, dizziness and confusion, may occur. These symptoms can cause decreased athletic performance.

SUMMARY OF THE INVENTION The present invention therefore provides an aqueous beverage comprising water, a long chain glucose polymer having at least five repeating glucose units , natural sugars, and electrolytes. It is preferred that the aqueous beverage have an osmolality of less than 250 mSOm/kg. The invention can also be supplied in the form of a mix containing the foregoing ingredients without water. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The present invention utilizes long chain glucose polymers to offer improvements over the prior art solutions for rehydration and carbohydrate supplementation. Glucose polymers allow a solution to have a lower osmolality than similar solutions containing the same amount of glucose units in simple, shorter chain sugars; i.e., there are fewer actual particles for the same caloric content. The longer chain glucose polymers break down in the plasma as they are metabolized into simple sugars, providing more energy to the body over a longer period of time. The present invention provides a rehydration fluid which has a combination of lower osmolality and higher calories per serving than provided for in the prior art. The present invention provides a rehydration fluid having low osmolality, which results in minimizing gastric transit times, thereby providing quicker fluid absorption, more efficient fluid utilization by the body, reducing gastric upset, and improving utilization of the available carbohydrates. The present invention also delivers sufficient carbohydrates to replenish the calories used from strenuous activity which either alleviates or prolongs the user's time to exhaustion. Thus, the rehydration fluid of the present invention provides a substantial amount of carbohydrate without increasing gastric transit time and provides a balance between osmolality and available energy stores. The carbohydrate component of the present invention is derived from both relatively high molecular weight (long chain) glucose polymers and simple sugars, e.g., fructose, glucose and others, to accelerate hydration and recovery after exercise. By selecting state of the art long chain glucose polymers and combining them with simple sugars like fructose, glucose or ribose the rehydration fluid of the present invention can achieve effective loading of muscles and liver with glycogen. The long chain glucose polymers preferably have repeating glucose units (n) from n=5 to n=20, more preferably n=10 to n=20. In a typical formulation at least 30 % by weight of the added glucose polymer will have glucose units n=10 or greater. Moreover it is preferred that the added glucose polymer and simple sugars comprise from about 50% by weight to 80% by weight of the total carbohydrates added to the formulation. While any of a variety of glucose polymers can be used for the present invention, high molecular weight glucose polymers derived from corn syrup are preferred. One such polymer is sold under the trademark Clintose CR-24 by Archer-Daniels-Midland Company of Decatur, Illinois. The total concentration of carbohydrates used depends upon the desired effect.

The concentration of carbohydrate used is dependent upon the degree of dehydration. If fluid replacement were paramount, a rehydration fluid containing 7% carbohydrates would be preferred. A rehydration fluid containing from 15-25% carbohydrates would be preferred for replacing lost glycogen when rehydration is not a significant factor. To primarily replace lost fluids, the present invention provides a rehydration fluid having a concentration of carbohydrates that results in an osmolality conducive for optimizing rehydration. Where it is desired to have a fluid designed to deliver high levels of carbohydrates, the rehydration fluid of the present invention provides the similar calories per serving with lower osmolality than products on the market, thereby enhancing fluid delivery. When rehydration is paramount, the rehydration fluid of the present invention provides an osmolality from 0 - 500 mOSm/kg in order to ensure shorter gastric transit times and rapid infusion of the available liquids. More preferably, the osmolality may range from 80 to 250, and most preferably from 120 to 180 mOSm/kg. In order to carbo- load before or after activity, when rehydration is not as paramount, the rehydration fluid of the present invention provides an osmolality range from 150 to 250 mOSm/kg to accommodate a higher volume of carbohydrates and thus increased caloric intake.

In addition to the carbohydrate sources, the rehydration fluid of the present invention can include beneficial electrolytes for replacement of excreted salts. By using a blend of glucose polymers, natural sugars and electrolytes, the present invention maintains an exceptionally low osmolality and offers rehydration and carbohydrate delivery performance that is superior to sports drinks in the market.

With the advantage of the present invention's ability to deliver high levels of calories per serving at low osmolalities, additional supplemental materials can be added to the fluid of the present invention for further supplementation without grossly affecting the performance of the fluid. The osmolality and caloric properties of the rehydration fluid of the present invention allows further ingredients to be added to the rehydration fluid for the formulation for a variety of needs. For instance, various supplemental materials may be added to the rehydration fluid of the present invention for rapid rehydration during strenuous activity, pre- and post-activity carbohydrate delivery, a higher osmolality solution for lower stress activities, and kid friendly formulations. In addition to the sports and fitness categories, additional nutritional and therapeutic formulations are possible. For instance, the rehydration fluid of the present invention could be modified with supplemental materials for a formulation for recovery from stress or a medical event such as surgery. To use the rehydration fluid of the present invention for these various purposes, supplemental materials such as additional nutrients and/or sources of energy may be added to the rehydration fluid of the present invention while maintaining a low osmolality for improved absorption and utilization of the supplemental material in the digestive system of the user. Such supplemental materials may include, but are not limited to, simple sugars, soluble fibers, electrolytes, vitamins, minerals, amino acids, probiotics, iodine, glutamine sources, and caffeine or other stimulants.

By targeting the osmolality for rapid rehydration, or slightly higher to ensure beneficial delivery of available carbohydrates, or even adding additional nutrients for the preferred effect, the rehydration fluid of the present invention may be customized for a variety of specific and general needs.

The present invention can be formulated as a granulated powder for constitution in pure water, can be prepared as a liquid concentrate, or can be prepared as a ready-to- drink beverage. A typical liquid formulation will include high molecular weight glucose polymers in the amount of 5 to 25 g/500 ml and simple sugars from 5 to 15 g/500 ml. Other additives such as magnesium citrate, citric acid, dipotassium phosphate, vitamins such as vitamin C, sodium chloride, xanthenum gum and flavoring can be added in amounts ranging from 0 to 2 g/500 ml. EXAMPLES

The following examples are intended to be illustrative of the invention and are not intended in any way to limit the scope thereof. The procedure for raising the osmolality is set forth in Pesce, A., and Kaplan, L., Methods in Clinical Chemistry, First Edition, Bircher, S., Ed., pages 18-21, C.V. Mosby Co., St. Louis, Missouri (1987). EXAMPLE 1

A ready-to-drink solution of low osmolality, high carbohydrate ready-to-drink fluid was prepared by adding the following ingredients to 500 ml of distilled water.

The hydration liquid thus prepared has an osmolality on the order of 144 to 161. EXAMPLE 2

A second hydration fluid was prepared with the following ingredients.

This hydration fluid had an osmolality of 157. EXAMPLE 3

A third hydration fluid was prepared containing the following ingredients.

This fluid had an osmolality of 160. EXAMPLE 4

Another hydration fluid was prepared having the following ingredients.

This fluid had an osmolality of 168. EXAMPLE 5

This fluid had an osmolality of 183. EXAMPLE 6

Another hydration fluid was prepared containing the following ingredients.

This fluid had an osmolality of 172.

While the preferred embodiment of the invention has been illustrated and described, it will be appreciated that various changes can be made therein without departing from the spirit and scope of the invention.

Claims

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. An aqueous beverage comprising: water a long chain glucose polymer having at least 5 repeating glucose units.

2. The beverage of Claim 1 further comprising natural sugar and electrolytes.

3. The beverage of Claim 2 wherein said glucose polymer has from 5 to 20 repeating glucose units.

4. The aqueous beverage of Claim 3 wherein said glucose polymer has at least 10 repeating glucose units.

5. The aqueous beverage of Claim 1 wherein said aqueous beverage has an osmolality of from 0 to 250.

6. The aqueous beverage of the previous claim wherein said osmolality ranges from 80 to 250.

7. The aqueous beverage of the previous claim wherein said osmolality ranges from 120 to 180 mOSm/kg.

8. The aqueous beverage of Claim 1 wherein said glucose polymer is derived from corn syrup.

9. A mix for preparing an aqueous beverage comprising a long chain glucose polymer having at least 5 repeating glucose units, and a natural sugar.

10. The beverage mix of Claim 9 further comprising electrolytes.

11. The beverage mix of Claim 9 wherein said glucose polymer has at least 10 repeating glucose units.

12. The beverage mix of Claim 9 wherein said glucose polymer has from 5 to 20 repeating glucose units.

13. The beverage mix of Claim 9, when mixed with water having an osmolality of less than 250 mOSm/kg.

14. The beverage mix of Claim 12 wherein at least 30% by weight of the added sugars is glucose polymer having at least 10 repeating glucose units.

15. The beverage of Claim 14 wherein the total sugars added to the mix comprise from a bout 50% to about 80% of the total carbohydrates added to the mix.