Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
2000-02-10
2003-02-18
Seidel, Marianne C. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S023000, C514S054000, C514S060000, C514S574000, C514S578000, C514S634000, C514S665000, C424S439000, C530S380000, C530S360000, C530S399000, C530S832000, C530S829000, C530S833000
Reexamination Certificate
active
06521591
ABSTRACT:
FIELD OF THE INVENTION
The invention is concerned with pharmaceutical or nutritional compositions suitable for increasing muscular mass (“lean body mass”), e.g., for athletes, and for preventing loss of lean body mass that may occur in periods of rest and during recovery from disease.
BACKGROUND
Products intended for increasing muscle mass are commercially available, such as the product PHOSPHAGAIN (a creatine containing supplement). A review of nutritional supplements for increasing muscle mass has been presented by Clarkson and Rawson in
Crit. Rev. Food Sci. Nutr.
39 (1999) 317—328. They conclude that many claims of this effect are unsupported, and that the weight gain following of creatine ingestion is most likely water retention but that it could also be due to some new muscle protein. From this review, we learn that very little evidence exists that ergogenic components indeed improve athletic performance.
According to U.S. Pat. No. 5,726,146, lean body mass can be increased without increase body fat by administration of a supplement containing creatine, taurine, and ribonucleic acid, optionally with carbohydrate for enhancing cellular uptake of these ingredients.
WO 98/43617 discloses a dietary supplement comprising L-carnitine, coenzyme Q10 and taurine useful in the correction of the abnormality in mitochondrial energetics occurring in cardiac failure and certain other diseases. It further discloses a high protein, high calorie nutritional feeding supplement comprising these three nutrients together with cysteine, vitamin E, vitamin C, selenium, and thiamin. The protein fraction can comprise of normal (i.e. denatured) whey proteins, 1:1 with casein.
WO 95/10192 discloses a nutritional drink containing colostrum, for the purpose of improving physical performance and recovery. The colostrum is defatted and decaseinated, and sterilized by filtration.
WO 99/56758 describes a food composition for use in changing body composition (increased lean tissue) and/or physical work capacity, which contains undenatured colostrum, in particular colostrum derived growth factors and colostrum-derived casein. The composition may further contain vitamins minerals, amino acids, and carbohydrates.
There is a need for a nutritional and/or pharmaceutical preparation that indeed helps to increase muscle strength during training. During periods when training efforts have to be stopped, e.g. because of injuries or holidays, it is frequently observed that muscle mass that was built up during exercise rapidly decreases, and a lot of time is normally required to regain the level that was previously present. Losses in lean body mass are also observed frequently in persons that have to be inactive for quite a while, e.g. because they have to stay in bed to injury, disease or other disorders. Thus, there is also a need for effective formulations, and especially nutritional formulations, that help prevent losses of body mass during these periods.
Muscle consists of proteins, like myosine and actin, lipids and carbohydrates. Skeletal muscle tissue is continuously broken off and replaced in a dynamic process that depends on mechanical damage, exercise and feeding status at a particular point in time.
DESCRIPTION OF THE INVENTION
It has now been found that the simultaneously or sequential administration of
1-component that triggers anabolism (initiators),
2-components that provide building blocks (substrates) for biosynthesis of muscle tissue, and
3-components that facilitate biosynthetic processes (facilitators) increases, for a certain period of time, lean body mass and/or can prevent catabolism in periods of rest.
Sequential use means that the different components can be administered separately during the day, but they must be consumed during the same day. In this way, for example a product with one or more facilitators is consumed first, followed by consumption, e.g. 2 hours after consumption of the first product, of an effective amount of substrate and initiator in the same product. However, preferably all three types of components are consumed simultaneously in one product.
The invention pertains to pharmaceutical and/or nutritional compositions suitable for enhancing muscular anabolism, i.e. production of muscle tissue or reduction of loss of muscle tissue. The compositions according to the invention comprise an initiator for muscular tissue production, a facilitator for biosynthesis, and a substrate. They furthermore comprise a facilitator, including creatine or a functional equivalent, and optionally further components facilitating tissue production, and also a substrate comprising e.g. carbohydrates, amino acids etc.
The products can have a powdered structure, packed in sachets or cans or similar reservoirs. Other dry forms that are equally suitable are cereals and bars. The product can also have the form of a drink, e.g., based on a dairy drink (mil, whey) or fruit juice (orange, apple, grape). For liquid products it is advantageous to let it have a pH below 4.2 in order to stabilize some of the active components. The product can also have the form of a paste or spread or sauce.
Initiators
The initiators (also referred to as triggering substances or triggers) to be used in the compositions of the invention are components that start up the anabolic processes. Examples are anabolic growth factors like Insulin-Like Growth Factor (IGF-1). These must be present as part of an extract of a protein-rich food ingredient, in particular in an extract from a proteinaceous material of animal origin, like mil, blood or egg. Undenatured whey and especially undenatured colostrum in particular bovine colostrum comprises a variety of anabolic trigger substances. The high effectivity of whey and colostrum that was found may also be explained by the presence of components that increase the bioavailability of the initiator components. In case of anabolic growth factors, such components are binding proteins.
Specific extracts of animal origin may be used as a source of triggers for anabolism, providing that the extraction procedures do not affect the trigger components. The F
0
value, defined in the Manual of Common Methods, defines decimal reductions of germs as a result of heat treatment of food products. Thus an F
0
value of 3.0 defines a thousand-fold reduction of germs and is achieved by treatment at 121° C. with a Z value of 10. A heat treatment above F
0
=3.0 normally destroys most of these trigger components. Thus the extracts should not have been subjected to a heat treatment with an F
0
of 3.0 or higher, and preferably any heat treatment should have an F
0
of less than 2.4. Most preferably, a heat treatment, if any, should not have a F
0
of more than 0.2.
Suitable methods for obtaining such products avoiding substantial heat treatment are described in the art and include filtration and centrifugal techniques. The amount of extract can be as low as 5 mg per daily dose, if a high degree of purification of the triggering substances from the proteinaceous material is obtained. However, when bovine colostrum is used as sole source for triggering substances, at least 5 g of the product, that is obtained by using the method disclosed in WO 97/16977, should be included in a daily dose according to the invention.
The inclusion of insulinotrohic components like digestible carbohydrates and arginine and lysine can further enhance the triggering activity of extracts of animal proteins. Arginine and lysine should be included in amounts of more than 1.0 g and preferably more than 1.5 g per daily dose. Carbohydrates are preferably glucose polymers like maltodextrines and should be present in an amount of more than 4 g and preferably more than 8 g.
Substrates
In order to allow an adequate rate of biosynthesis of muscle tissue, the presence of sufficient amounts of substrate in the form of a variety of amino acids is required. It appears that requirements for protein in athletes are higher than in non-athletes. Daily requirements in strength athletes are above 120 g protein and in endurance athletes above 100
Hageman Robert Johan Joseph
Smeets Rudolf Leonardus Lodewijk
Delacroix-Muirheid C.
N.V. Nutricia
Seidel Marianne C.
Young & Thompson
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