Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2000-01-31
2003-04-08
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S400000, C424S464000, C424S489000, C424S450000, C424S484000, C424S499000
Reexamination Certificate
active
06544547
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a module of nutritional components which supports total methionine metabolism in man, for use in a universal medicinal food. The invention also relates to food products containing this module and to a method of producing food products by using selected amounts of the module.
BACKGROUND
Methionine is metabolised in man via a multi-step pathway, the transsulfuration pathway. Several intermediate products are formed in this pathway, which play a dominant role in other biochemical pathways as well. For example, the reaction product S-adenosyl methionine is extensively used in many methylation reactions; homocysteine is the main methyl acceptor in folate metabolism and also the conversion of betaine to dimethylglycine (via methylation of homocysteine) strongly influences folate metabolism.
Another intermediate in the transsulfuration pathway is cystathionine generated by reaction between homocysteine and serine, that may split into cysteine and 2-oxy-butyrate. The latter is involved in the metabolism of several other compounds (e.g. threonine). Cysteine is metabolised to various useful products such as taurine and sulphates. It is also an important precursor for glutathione in the liver and some other tissues. Glutathione that is produced in the liver has to be transported to cell compartments in some peripheral organs in order to exhibit its activity. Intracellular glutathione levels are in turn strongly influenced by the presence of reducing equivalents and amino acids in the cell.
Herein we define total methionine metabolism as those biochemical pathways which occur in mammals and in which metabolites of the methionine transsulfuration pathway (methionine, S-adenosyl methionine, S-adenosyl homocysteine, homocysteine, cystathionine and cysteine) and main metabolites thereof (taurine and glutathione) are involved (see scheme below).
Many diseases in man have been associated with impaired functioning of parts of total methionine metabolism. Lack of the body capacity for methylation (by shortages of available S-adenosyl methionine) has been related to diseases like cancer, improper wound healing, diabetes, neurological diseases like Alzheimer or Parkinson' disease (WO 96/33703). Shortages of folate have been associated with neural defects and several other problems.
Dysfunction of methionine metabolism may also lead to increased homocysteine plasma levels, which are associated with cardiovascular problems. Cysteine deficiencies may lead to low taurine levels, low sulphation capacity and low intracellular glutathione levels. Shortages of cysteine have been associated with diseases like diabetes, cardiovascular disease, cancer, rheumatoid arthritis, etc.
Glutathione can play many important roles in the cell. A substantial part of glutathione must be in the reduced form (having a specific redox potential) in order to allow it to be active. Deficiencies of glutathione have been associated with all kinds of radical-mediated diseases, such as chronic inflammations, rheumatoid arthritis, with the occurrence of cancer and impaired immune functions against infection.
EP-A-532369 (Bissbort) describes the pharmaceutical use of L-methionine for enhancing the methylation capacity in man, e.g. for improving the immune response, combating viral infections and increasing creatine production. Methionine may be combined with folic acid, pyridoxine (vitamin B
6
), cyanocobalamine (vitamin B
12
) and magnesium. A daily dose comprises 1.5-5 g (3 g) of L-methionine, 250-2500 mg (600 mg) of magnesium chloride, 30-120 mg (100 mg) of magnesium carbonate, 0.6-20 mg (8 mg) of folic acid, 1.5-25 mg (10 mg) of vitamin B
6
and 15-25 &mgr;g (20 &mgr;g) of vitamin B
12
.
WO 93/15738 (Waldthaler) discloses medicaments containing thymine or its equivalents in combination with methionine, pyridoxine and/or cyanocobalamine and optionally penicillin G for the treatment of disorders in the folate metabolism.
WO 96/02252 and WO 96/33727 (Knoll) disclose the use of S-adenosyl-L-methionine for the treatment of damage caused by temporary and permanent local ischaemias, respectively.
EP-A-347864 (Strydom) discloses an anti-atherogenic agent which lowers the plasma level of free sulphydryl groups of homocysteine and cysteine and which can contain oxidising agents and folic acid, pyridoxine (vitamin B
6
), cyanocobalamine (vitamin B
12
) and choline or betaine.
Likewise, EP-A-595005 and EP-A-595006 (Vesta) teach the use, for adults and infants respectively, of specific ratios of folic acid, pyridoxine and cyanocobalamine for suppressing high homocysteine and methionine levels in plasma, which are the cause of metabolic disturbances. According to the latter document, pyridoxine should at least partly be present in its accessible pyridoxal form. Riboflavin (vitamin B
2
), ascorbic acid (vitamin C), tocopherol (vitamin E), zinc and selenium may also be present.
EP-A-705542 discloses a complete dietary composition for adolescents and especially for children of 1 to 6 years having diseases such as intestinal disorders. The composition contains 50-65 (63) energy % of carbohydrates, 20-35 (25) en. % of fats and 10-20 (12) en. % of free amino acids with a specific amino acid content.
A multivitamin preparation supporting the immune system is disclosed in GB-A-2,292,522. It contains an amino acid blend, vitamins C, E, A, D and B complex, minerals and trace elements. Important amino acids are: methionine (90 mg), valine, leucine, threonine (70 mg), phenylalanine, lysine, isoleucine and tryptophane. Levels of B complex vitamins may be: B1 (50 mg), B2 (100 mg), B6 (100 mg), pantothenic acid (300 mg), nicotinamide (50 mg), B12 (2.5 &mgr;g), folic acid (150 &mgr;g) and biotin (50 &mgr;g). The preparation does not contain carbohydrates or full proteins. No recommended dosages are given.
U.S. Pat. No. 5,215,750 discloses a composition for inducing weight loss, containing glutamine as the major component, and further a broad range of vitamins and minerals, without further amino acids, proteins, carbohydrates or fats.
Despite these proposals, the diseases referred to above are still very common and therefore there exists a need for nutritional products that may support prevention and treatment of these diseases.
Many persons suffer from deficiencies in essential amino acids, such as methionine, essential fatty acids, vitamins, minerals, trace elements or other food components, as a result of bad eating habits, disorders in nutrient absorption, or increased nutrient demands. A minority of patients suffer from metabolic disorders in the transsulfuration pathway; some enzymes have low activity or do not function at all. Thus there is a need for a nutritional product which supports total methionine metabolism and at the same time compensates for the shortages in nutrients that may occur in patients in need of support of methionine metabolism.
Several intermediates of total methionine metabolism can be quite reactive in the human body, and the reactive forms (reduced homocysteine, cysteine, glutathione) are not easily transported over the cell membranes. It is therefore important to support the methionine metabolism in such a way that no undesired side effects occur and at the same time intracellular levels of useful intermediates are maintained, even in the diseased state.
The reactive species are also easily oxidised in aqueous solution, and it is therefore an object of the invention to provide a nutritional composition with a sufficient shelf stability. Some nutritional components that play an important part in the methionine metabolism have bad organoleptic properties. It is therefore an object of the invention to provide a nutritional product that is well acceptable to the consumer.
Many attempts have been made up to now to find solutions to these problems. All these prior attempts have concentrated on a part of the total methionine metabolism, relying on an adequate functioning of the rest of the biochemical pathways of total methionine metabolism in man to maintain homeostasis and
Joynes Robert M.
N. V. Nutricia
Page Thurman K.
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