Food or edible material: processes – compositions – and products – Products per se – or processes of preparing or treating... – Protein – amino acid – or yeast containing
Reexamination Certificate
1998-11-30
2001-06-12
Hendricks, Keith (Department: 1761)
Food or edible material: processes, compositions, and products
Products per se, or processes of preparing or treating...
Protein, amino acid, or yeast containing
C426S800000, C426S806000, C426S072000, C426S439000, C424S439000
Reexamination Certificate
active
06245378
ABSTRACT:
This application is a 371 application of PCT/IT98/00069 filed on Mar. 27, 1998.
The present invention relates to a nutritional supplement comprising a combination of “carnitines” as the basic active ingredients, where what is meant by “carnitines” are L-carnitine and the first terms of the series of lower (short-chain) acyl L-carnitines, or their pharmacologically acceptable salts.
This nutritional supplement is particularly suitable both for modulating the adaptation of skeletal muscle and of the liver in individuals who engage in intense, prolonged physical activity and for combating the sensation of muscular fatigue and weariness presented by asthenic subjects even in the absence of any type of more or less intense physical activity.
Anyone who engages in sporting activity, whether as a professional or as an amateur, wishes to achieve the maximum degree of adapation of the -skeletal muscles to the ability to support prolonged periods of intense physical effort in a short space of time and then maintain it for as long as possible. The quest for this optimal degree of physical fitness may make for the abuse of drugs, particularly steroids. It is well known that such drugs can increase protein synthesis and consequently enhance the growth of muscle mass to a greater extent than could be achieved by training and diet. The use of such drugs, however, is unquestionably harmful as well as being illegal when practised in the sphere of professional sport.
It is therefore clear that the only way to achieve the above-mentioned objective correctly consists in undergoing appropriate training schedules in combination with suitable diets, enhanced with suitable nutritional supplements. What is meant by asthenia is that diffuse set of a specific symptoms typical of the present-day stressful conditions of life particularly prevalent in the large urban conurbations and affecting a vast population, largely regardless of factors related to age and social condition, and characterised by a lack of loss of muscular strength, weariness, with easy fatigability and an inadequate reaction to stimuli.
The object of the present invention is to provide a nutritional supplement which is useful for both the above-mentioned categories of consumers.
Over the decades which have now elapsed since the fundamental discovery (Fritz I. B.: The metabolic consequences of the effects of carnitine on long-chain fatty acid oxidation. In Cellular Compartmentalization and Control of Fatty Acid Metabolism. Edited by F. C. Gran, New York, Academic Press, 1968, pp. 39-63) that L-carnitine is unique in performing a vital physiological role as the carrier of long-chain fatty acid across the internal mitochondrial membrane into the mitochondrial matrix, the sit of their oxidation, and since it was first established (Engel and Angelini, Science, 1973, 179: 899-902) that a primary deficiency of L-carnitine is the cause of a severe and sometimes fatal, though rare, form of myopathy (lipid storage myopathy), our knowledge of the pathological consequences of primary and secondary L-carnitine deficiencies and, conversely, of the therapeutic and nutritional value of an exogenous supply of carnitine has increased enormously.
Carnitine is present in all biological tissues in relatively high concentrations as free carnitine and in lower concentrations in the form of acyl carnitines which are metabolic products of the reversible reactions:
acyl CoA+carnitine&rlarr2;acyl carnitine+CoASH catalysed by three groups of enzymes, the transferases, which distinguish themselves mainly by their specificity for reactive substrates: the group of carnitine acetyl transferase (CAT) which have as their substrate the short-chain acyl groups (such as acetyl and propionyl), the group of carnitine octanoyl transferases (COT) which have as their substrate the medium-chain acyl groups and the group of carnitine palmitoyl transferases (CPT) which have as their substrate the long-chain acyl groups.
The important role of carnitine in intermediate metabolism, particularly in terms of its limited biosynthesis, serves to explain how a carnitine deficiency can occur as a secondary event in various pathological functions, involving different organs and apparatuses. The broadening of the clinical spectrum has been accompanied by a growing number of therapeutic opportunities related to the efficacy of this naturally occurring compound: efficacy which has revealed itself in all its potential with the observation that replacement therapy with L-carnitine reverses the dramatic clinical picture in patients suffering from lipid storage myopathy. The US Food and Drug Administration (FDA) has not only accorded L-carnitine the status of an orphan drug, but has also included it in the list of life-saving drugs.
Parallel to our deeper insight into the pathological implications related to primary and secondary carnitine deficiency there has been an impressive build-up of scientific and patent publications focusing mainly on L-carnitine and, to a substantially lesser extent, on a number of acyl carnitines.
Confining ourselves to a partial review of the picture, the use of L-carnitine has been proposed in the cardiovascular field for the treatment of cardiac arrhythmias and congestive heart failure (U.S. Pat. No. 4,656,191), of myocardial ischaemia and anoxia (U.S. Pat. No. 4,649,159); in the field of lipid metabolism disorders, for the treatment of hyperlipidaemia and hyperlipoproteinaemias (U.S. Pat. No. 4,315,944) and for normalising an abnormal ratio of HDL to LDL+VLDL (U.S. Pat. No. 4.255,449); in the field of total parenteral nutrition (U.S. Pat. Nos. 4,254,147 and 4,320,145); in nephrology, for combating myasthenia and the onset of muscle cramps caused by the loss of carnitine in dialysis fluid in chronic uraemic patients under regular haemodialysis treatment (U.S. Pat. No. 4,272,549); for counteracting the toxic effects induced by anticancer agents such as Adriamycin (U.S. Pat. Nos. 4,400,371 and 4,713,379) and by halogen-containing anaesthetics such as halotane (U.S. Pat. No. 4,780,308); in the treatment of venous stasis (U.S. Pat. No. 4,415,589); for counteracting the deterioration of a number of biochemical and behavioural parameters in elderly subjects (U.S. Pat. No. 4,474,812); for normalising triglyceride and Tumor Necrosis Factor (TNF) levels in patients suffering from AIDS and asymptomatic HIV-seropositive patients (U.S. Pat. No. 5,631,288).
The use of L-carnitine has also been proposed in combination with other active ingredients, as in the combination of L-carnitine plus coenzyme Q10 with a broad spectrum of metabolic/antiatherosclerotic activity (U.S. Pat. No. 4,599,232).
As regards the acyl carnitines, the use of acetyl L-carnitine is well known for the treatment of diseases of the central nervous system, particularly Alzheimer disease (U.S. Pat. No. 4,346,107), and for the treatment of diabetic neuropathy (U.S. Pat. No. 4,751,242), while propionyl L-carnitine has been proposed for the treatment of peripheral vascular disease (U.S. Pat. No. 4,343,816) and congestive heart failure (U.S. Pat. No. 4,194,006).
One thing which clearly emerges from the patent picture outlined here above, albeit in a concise and partial manner, is the distinctly greater weight and importance of L-carnitine compared to its acyl derivatives.
An analysis of the patent literature reveals that, in certain circumstances, mention is made of an equivalence of behaviour between L-carnitine and some of the lower acyl carnitines with regard to a given indication, an equivalence which, on closer inspection, is found to stem more from patent motivations aimed at obtaining the broadest protection possible than from the results of appropriate pharmacological/clinical research. This “equivalence” of behaviour is probably also suggested by the above-mentioned reversible equilibrium reaction between carnitine and the acyl carnitines.
From an examination of the scientific and patent literature it also emerges tat the attention of researchers has been constantly focused specifically on t
DuBois Philip
Hendricks Keith
Oblon & Spivak, McClelland, Maier & Neustadt P.C.
Sigma-Tau HealthScience S.p.A.
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