Compositions containing creatine and aloe vera extract

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical

Utility Patent

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Details

C424S195110, C424S489000, C514S937000, C514S970000, C514S773000, C514S777000

Utility Patent

active

06168802

ABSTRACT:

FIELD OF THE INVENTION
This invention relates to compositions for human consumption comprising creatine and Aloe Vera extract and to a method of providing stable creatine containing compositions.
BACKGROUND OF THE INVENTION
In the last few years there has been considerable interest among athletes in creatine, which occurs abundantly in skeletal muscle. Creatine plays a pivotal role in the regulation and homeostasis of skeletal muscle energy metabolism and it is now generally accepted that the maintenance of phospho-creatine availability is important to the continuation of muscle force production. Although creatine synthesis occurs in the liver, kidney and pancreas it has been known for sometime that the oral ingestion of creatine will add to the whole body creatine pool, and it has been shown that the ingestion of 20 to 30 g creatine per day for several days can lead to a greater than 20% increase in human skeletal muscle total creatine content. Thus, WO94/02127 discloses the administration of creatine in amounts of at least 15 g (or 0.2-0.4 g/kg body weight) per day, for at least 2 days, for increasing muscular strength.
In fact, it was subsequently found that after several days of supplementation (20 g per day) with creatine it takes no more than 2 to 3 g per day to maintain the saturation of body stores. Creatine supplementation in an appropriate dose can provide improvements to athletes involved in explosive events, which include all events lasting from a few seconds to a few minutes (such as sprinting, swimming, weight-lifting etc). Endurance performance in events lasting longer than about 30 minutes appears to be unaffected by creatine supplementation. Creatine is a normal food component and is not a drug and its use is not contrary to official regulations. The biggest benefits of supplementation can be experienced by the elderly, vegetarians or those who eat no meat or fish since these people tend to have low muscle creatine content.
Aloe Vera (
Aloe barbadensis
) is a member of the lily family and is a cactus like succulent plant that grows in warm frost free climates. Central American Mexican Indians used Aloe Vera for centuries as a remedy for burns, to prevent blisters, peptic and duodenal ulcers and all types of stomach and intestinal disorders, kidney infections, topical and gastric ulcers as well as to promote longevity. Today Aloe Vera is becoming very popular and its benefits are scientifically recognized.
For the sake of clarity, the term Aloe Vera is used to refer to the plant and Aloe Vera extract to refer to compositions prepared by processing Aloe Vera (e.g. mashing, pulping, cutting, juicing and the like). Aloe Vera juice refers to the watery gel-like substances contained within Aloe Vera plants. Thus, Aloe Vera juice is one particular example of an Aloe Vera extract.
The main use of Aloe Vera in the past has been to prevent inflammation, particularly to the skin, especially after burns. But there are many other uses. Experiments and research studies have shown that after using Aloe Vera juice, the output of the digestive enzymes and the bacterial population of the intestines are improved. Thus there has been an increasing interest in Aloe Vera extract as a medicament to be taken orally as people become more acquainted with its medicinal properties Among the several methods of presentation, there is a growing use of Aloe Vera juice in soft drinks which are fruit flavored, and these are quite palatable. The inclusion of creatine in such a soft drink would be highly desirable because the Aloe Vera drink would be much more beneficial to health than an unsupplemented ordinary fruit drink.
Aloe Vera juice is acidic (commonly about pH3). Likewise, popular fruit drinks are in the region of pH 3-4 because the acidity gives the drink a pleasant ‘bite’ to the palate. It is well known that creatine is unstable in aqueous solutions at acid or neutral pH, and is converted into the related compound creatinine. This is highly significant as creatinine has no muscle performance-enhancing effect and is excreted from the human body as a waste product in urine. In view of the foregoing, EP 0 669 083 teaches that aqueous drinks for human consumption comprising creatine must be weakly alkaline, in order to prevent the conversion of creatine into creatinine, and this has become the generally accepted opinion.
Furthermore, creatine has been used in the past only for the preparation of products with a meaty or savory flavor. For instance, Tonsbeek (U.S. Pat. No. 3,615,600) discloses and is concerned with artificial flavoring mixtures which can impart a meaty flavor to foods. Similarly de Rooji (U.S. Pat. No. 4,464,409) is concerned with meat flavoring. Yamazak (JP-A-59035663) prepares a meat flavor by heating a mixture comprising creatine at pH 5.0-7.0 at temperature of 80-130° C. for 30-120 minutes. Under these conditions most of the creatine would be converted to creatinine.
It would be a great advantage to present a fruit flavored drink containing Aloe Vera extract, in which the creatine therein was substantially stable.
SUMMARY OF THE INVENTION
It is therefore a first object of the present invention to provide an acidic composition for human consumption, comprising creatine and Aloe Vera extract.
It is a second object of the present invention to provide a method of storing acidic liquid or semi-liquid compositions comprising creatine, for human consumption, at below ambient temperature.
Another object of the present invention to provide a method of supplying a creatine and Aloe Vera extract containing composition for human consumption, the method including providing a creatine and Aloe Vera extract containing acidic composition as a dry, stable powder which, when mixed with water or a suitable aqueous solution gives an acidic drink comprising physiologically effective quantities of creatine and in which the creatine is substantially stable.
Another object of the present invention is to provide a composition comprising creatine in substantially stable form, wherein the composition is suitable for human consumption and comprises solid creatine suspended in an edible matrix.
DETAILED DESCRIPTION OF THE INVENTION
In a first aspect the invention provides an acidic composition for human consumption, comprising creatine and Aloe Vera extract. The term acidic is intended to mean that the composition has a pH below 7.0. In particular the composition desirably has a pH between 2.5 and 6.5, preferably between 3.0 and 6.0. Typically the composition has a pH in the range 3.5-5.5 which, to the human palate, has a refreshingly sharp taste without being too acidic.
The creatine content of the composition may be present as any active form of creatine, (e.g. creatine phosphate) but creatine monohydrate is found particularly convenient as a source of creatine.
The Aloe Vera extract content of the composition may be present as an extract of the Aloe Vera plant, Aloe Vera juice, gel or lyophilized product such as those supplied commercially. Aloe Vera juice is 99.5% water and 0.5% solids. When the lyophilized form is used it is important to rehydrate with an appropriate amount of water.
The composition may be in the form of a dry powder or may be provided in liquid or semi-liquid form (e.g. as a drink or yogurt, respectively). In preferred embodiments the composition is a drink.
Surprisingly, the present inventors have found that the conversation of creatine to creatinine at acidic pH is actually sufficiently slow as to allow physiologically useful amounts of creatine to remain in the composition after considerable periods of time, such that creatine may be presented in acidic formulations, contrary to the teaching of the art. In particular, the conversion of creatine to creatinine can be greatly inhibited by storage of the compositions at lower than ambient temperatures (e.g. in commercial chiller cabinets at 0-8° C.).
Thus, in a second aspect the invention provides a method of storing an acidic liquid or semi-liquid compositions comprising creatine, for human consumption, the method, comprisi

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