Drug – bio-affecting and body treating compositions – Enzyme or coenzyme containing – Multienzyme complexes or mixtures of enzymes
Reexamination Certificate
2002-04-03
2003-05-06
Henley, III, Raymond (Department: 1614)
Drug, bio-affecting and body treating compositions
Enzyme or coenzyme containing
Multienzyme complexes or mixtures of enzymes
C514S188000
Reexamination Certificate
active
06558666
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to endurance improving carbohydrase enzyme food supplements. In particular, the invention relates to an endurance improving carbohydrase enzyme food supplements comprising a unique combination of at least one cellulase fungal enzyme, at least one alpha amylase fungal enzyme, at least one hemicellulase fungal enzyme, and at least one chromium(III) compound.
2. Related Prior Art
Many athletes rely upon various carbohydrate-containing foods and carbohydrate-containing food supplements in order to provide an ample supply of nutrients for energy production. Many popular food supplements used by athletes today are based on glucose polymers rather than starch. The glucose polymers used in such supplements are typically known collectively as maltodextrins and oligosaccharides, and are considered more desirable because they yield their energy more slowly than does simple sugar or starch. This provides a smoother rise in blood glucose that, in turn, results in a slower and more sustained energy boost.
U.S. Pat. No. 5,817,350 to Rhode, Jr., et al. discloses carbohydrase fungal enzyme food supplement compositions intended to replace food supplements containing glucose polymers by using the human stomach as a reaction vessel in which ingested insoluble dietary starches and other complex carbohydrates are converted into soluble dextrins and oligosaccharides, which are then used by the body as a primary source of energy over a prolonged period of time. When taken in the form of a tablet, capsule, powder, or liquid food supplement with carbohydrate-containing foods or carbohydrate-containing food supplements, the carbohydrase fungal enzyme food supplement compositions convert ingested insoluble dietary starches and other complex carbohydrates into soluble dextrins and oligosaccharides, which can then be used by the body as a primary source of energy.
The carbohydrase fungal enzyme food supplement compositions disclosed in U.S. Pat. No. 5,817,350 are of value to athletes, such as, e.g., joggers, cyclers, distance runners, and other endurance athletes, seeking to prolong the blood glucose elevation that follows ingestion of assimilable carbohydrates in that the carbohydrase fungal enzyme food supplement compositions hydrolyze starches and other carbohydrates in the stomach to produce glucose polymers, thereby freeing the athlete from reliance upon expensive and inconvenient supplements. The combination of carbohydrase fungal enzymes effectively converts insoluble dietary starches in the gastrointestinal tract into soluble energy-rich maltodextrins and oligosaccharides, which mediates the release of glucose from starches in a sustained release manner.
Chromium(III) is known to be an essential trace mineral, such that small quantities must be ingested on a regular basis to maintain the health of an individual. For example, Clarkson et al.,
International Journal of Sport Nutrition,
1991, 1, 289-293, report that the National Research Council has established a recommended dietary allowance (“RDA”) of from 50 to 200 &mgr;g of chromium as a safe and adequate daily dietary intake, and that chromium serves as a cofactor to insulin action. Clarkson et al. studied the effect of chromium supplementation of 200 &mgr;g daily on lean body mass, and found that male college athletes participating in weight-lifting programs taking a chromium supplement showed a significant increase in lean-body mass when compared to others in the program taking a placebo. However, Clarkson et al. recommend taking a chromium supplement only when chromium intake is suboptimal.
Anderson,
Nutrition Reviews,
1998, 56, 266-270, reports that human studies on the effects of chromium on lean body mass failed to show an effect of a 200 &mgr;g chromium supplement on body composition, but that positive results were obtained after 24 weeks when a 400 &mgr;g chromium supplement was taken.
Lefavi et al.,
International Journal of Sport Nutrition,
1992, 2, 111-122, report that athletes may have an increased requirement for chromium due to excessive chromium loss and marginal chromium intake resulting from exercise. Lefavi et al. also report that, as chromium is a nutrient and not a drug, anabolic steroid-like muscle mass increases following dietary supplementation of any chromium compound in normal, healthy athletes should not be expected.
Davis et al.,
International Journal of Sport Nutrition and Metabolism,
2000, 10, 476-485, report that acute chromium supplementation prior to exercise does not improve performance and resistance to fatigue. Test results indicate that ingestion of a carbohydrate electrolyte drink prior to and during exercise did provide a benefit, but the addition of chromium did not enhance the effect provided by the carbohydrate-electrolyte drink.
It has been unexpectedly found that the addition of at least one chromium(III) compound to a carbohydrase fungal enzyme food supplement composition, such as those disclosed in U.S. Pat. No. 5,817,350 to Rhode, Jr., et al., the contents of which are incorporated herein in their entirety by reference, enhances endurance and fatigue resistance when compared to other endurance enhancing food supplements, including the compositions disclosed by Rhode, Jr. et al.
SUMMARY OF THE INVENTION
The present invention is directed to a chromium(III)-containing enzyme food supplement composition comprising effective amounts of at least one cellulase fungal enzyme, at least one alpha amylase fungal enzyme, at least one hemicellulase fungal enzyme, at least one chromium(III) compound, and, optionally, at least one acceptable carrier. Preferably, the cellulase fungal enzyme is present in an amount of at least 1,000 CA per gram of composition, the alpha amylase fungal enzyme is present in an amount of at least 1,000 DU per gram of composition, and the hemicellulase fungal enzyme is present in an amount of at least 50 HCU per gram of composition. The chromium(III) compound is preferably present in an amount equivalent to up to about 475 &mgr;g of elemental chromium, more preferably in an amount of from about 50 &mgr;g to about 400 &mgr;g of elemental chromium, most preferably an amount of from about 200 &mgr;g to about 400 &mgr;g of elemental chromium, and may be an ionic chromium(III) compound or a chelated chromium(III), such as, e.g., an amino acid chelate of chromium(III), an organically bound chromium(III), chromium nicotinate, chromium polynicotinate, or chromium picolinate.
The invention is further directed to a method of improving endurance and fatigue resistance in a mammal, including humans. The method comprises administering a chromium(III)-containing enzyme food supplement composition of the invention to a mammal prior to or during exercise by the mammal, thereby improving endurance and fatigue resistance.
DETAILED DESCRIPTION OF THE INVENTION
As used herein, a Cellulase Activity Unit (CA unit) is defined as that quantity of enzyme required, under the conditions of the assay stated in the Food Chemicals Codex, Third Edition, General Tests and Apparatus, Cellulase Activity, pp 483-484, to reduce the viscosity of 200 grams of a 5% solution of the specified sodium carboxymethylcellulose substrate from 400 to 300 cps at 35° C. and pH 5.0 in one hour. An Alpha-Amylase Dextrinizing Unit (DU unit) is defined as the quantity of alpha-amylase that will, under the conditions of the assay stated in the above-referenced text, section Alpha Amylase Activity (Non-Bacterial), pp 479-482, dextrinize soluble starch in the presence of an excess of beta-amylase at the rate of one gram per hour at 30° C. A Hemicellulase Unit (HCU unit) is defined as that activity that will produce a relative fluidity change of 1 over a period of five minutes in a locust bean gum substrate under the conditions specified in the assay stated in the above-referenced texts, section Hemicellulase Activity, pp 490-491.
Also, as used herein, the term chromium(III) compound includes organic and inorganic chromium (III) compounds and che
Fitzpatrick ,Cella, Harper & Scinto
Henley III Raymond
Triarco Industries, Inc.
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