Nutritional supplement for increased energy and stamina

Details Nutritional supplement for increased energy and stamina Nutritional supplement for increased energy and stamina

2000-09-08

2002-11-12

Padmanabhan, Sreeni (Department: 1617)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Food or edible as carrier for pharmaceutical

C514S558000, C514S560000

Reexamination Certificate

active

06479069

ABSTRACT:

TECHNICAL FIELD
The present invention is generally directed to dietary supplements and nutritional beverages. More specifically, the present invention relates to the addition of the combination of lipoic acid and carnitine to these compositions.
BACKGROUND OF THE INVENTION
Liquid diet supplements or nutritional drinks have been used for years to provide needed calories, protein, vitamins and minerals to people too sick or frail to eat sufficient amounts of solid food. Now these products are being marketed as energy boosters to people who want to remain energetic, particularly those aged 50 and older. The oldest and by far the best selling nutritional drink is made by the Ross Products Division of Abbott Laboratories (Columbus, Ohio). For 1997, its sales exceeded $170 million, which does not even include the higher-calorie Ensure Plus® or the lower calorie Ensure Light® beverages. Another competitor for active older consumers include Sandoz Nutrition (Minneapolis, Minn.) which sells ReSource®, the official nutritional drink of the senior Professional Golf Association tour. Mead Johnson Nutritionals (Evansville, Ind.) also has been marketing its Boost® drink to seniors.
Nutritional drinks are sold in a variety of flavors and supply approximately the following:
Calories: 180-350
Total Fat: 0-13 grams
Sodium 130-220 mg
Sugars: 12-26 grams
Protein: 9-25 grams
Registered dietitians state that these nutritional drinks are better than a snack such as a bag of cheese curls and a soda. Although the nutritional drinks are being marketed as meal replacements, dietitians warn that the drinks are an inadequate substitute for three balanced meals. Each 8-ounce can or carton has about 20-25% of the Recommended Daily Allowance of an assortment of vitamins and minerals but lacks fiber and other nutrients found in nature.
These drinks were developed for a variety of conditions, including persons with increased nutritional needs (e.g., athletes and pregnant women), inactive geriatric patients, patients recovering from illness or surgery (who cannot otherwise attend to their needs), malnourished cancer patients. None have been specially formulated to meet the needs of active seniors and take into account the recent research on micronutrients.
Recent research has suggested that taking sufficient quantities of certain substances rejuvenates aged mitochondria, the failing powerhouses of cell metabolism. Numerous lines of evidence suggest that the organelles of cellular respiration, the mitochondria, degenerate with cellular aging (Shigenaga et al. 1994, PNAS 91, 10771). Unfortunately, the study of mitochondrial aging has been hampered because mitochondria isolated from older cells and host animals are fragile and heterogeneous. Hence the interpretation of any results is suspect as about half the mitochondria lyse during isolation. Recently a new method was developed for studying mitochondria in hepatocytes from old animals that avoids this problem (Hagen et al. 1997, PNAS 94, 3064-3069). Mitochondria from older animals are not only more fragile, but have about half the level of cardiolipin, a key lipid unique to mitochondria, without which they can not maintain a high membrane potential. Furthermore, Hagen et al. show that in hepatocytes from older animals, the mitochondria are lower in membrane potential and leak more toxic oxidants.
Carnitine and carnitine derivatives have been used as metabolites in animal husbandry and for human diet and therapy. U.S. Pat. No. 5,362,753 (Method of increasing the hatchability of eggs by feeding hens carnitine); U.S. Pat. No. 4,687,782 (Nutritional composition for enhancing skeletal muscle adaptation to exercise training); U.S. Pat. No. 5,030,458 (Method for preventing diet-induced carnitine deficiency in domesticated dogs and cats); U.S. Pat. No. 5,030,657 (L-carnitine supplemented catfish diet); U.S. Pat. No. 4,343,816 (Pharmaceutical composition comprising an acyl-carnitine, for treating peripheral vascular diseases); U.S. Pat. No. 5,560,928 (Nutritional and/or dietary composition and method of using the same); U.S. Pat. No. 5,504,072 (Enteral nutritional composition having balanced amino acid profile); U.S. Pat. No. 5,391,550 (Compositions of matter and methods for increasing intracellular ATP levels and physical performance levels and for increasing the rate of wound repair); U.S. Pat. No. 5,240,961 (Method of treating reduced insulin-like growth factor and bone loss associated with aging); etc. Similarly, mitochondrially active antioxidants including vitamins (especially C, E, B and D), glutathione, N-acetyl cysteine, lipoic acid, etc., have been used variously as human nutritional supplements and in dietary prophylaxis and therapy. For example, applications of lipoic acid have included U.S. Pat. No. 5,607,980 (Topical compositions having improved skin); U.S. Pat. No. 5,472,698 (Composition for enhancing lipid production in skin); U.S. Pat. No. 5,292,538 (Improved sustained energy and anabolic composition and method of making); U.S. Pat. No. 5,536,645 (Nutritive medium for the culture of microorganisms); U.S. Pat. No. 5,326,699 (Serum-free medium for culturing animal cells); etc.
The acceptance of age-associated cellular bioenergetic degradation is gaining acceptance as the reason that the current life expectancy is 80 years, but life potential is estimated at 120 years. Bioenergetic degradation may contribute to various diseases of the aged, including heart failure, degenerative brain disease, muscle and vascular diseases, as well as other syndromes. The authors also propose a redox therapy based on coenzyme Q10, as that has been demonstrated to improve heart functions of old rats and not significantly affect those function in young rats (Linnane A W, Kovalenki S and Gingold E B. Ann NY Acad Sci 854:202-13, 1998).
Coenzyme Q or ubiquinone plays a central role in the mitochondrial respiratory chain that captures energy from metabolism. It exists in mitochondria in the oxidized quinone form under aerobic conditions. In the reduced form ubiquinol, Q10 is an antioxidant. Q also is present in mitochondrial lipids. The structure of Q is very similar to those of vitamins K and E, which are characterized by a polyisoprenoid side chain. Coenzyme Q10 has ten polyisoprenoid side chains. Mitochondria need to maintain a large excess of Q, compared to other respiratory enzymes. Q is required to act on a mobile component of respiration that collects reducing equivalents from the more fixed complexes and passes them to other compounds.
Many conflicting reports have been published on the effectiveness of Q10 in various laboratory and clinical settings. Barbiroli et al reported that Q10 administration caused marked improvement in oxidative phosphorylation in both skeletal muscles and brains of patients with mitochondrial cytopathies due to enzyme defects (Biochimie 80(10): 847-53, 1998). On the other hand, Lass et al studied the Q10 and Q9 content in brain, heart, skeletal muscle and other organs but found a decrease in mitochondrial Q9 and Q10 only in aging skeletal muscle (Biofactors 9(2-4):199-205, 1999).
Life-long Q10 supplementation was studied in male rats and mice. Q10 did not prolong or shorten the lifespan of rats or mice. Plasma and liver levels were 2.6-8.4 times higher in the supplemented rats. Q10 levels in kidney, heart and brain were not affected by Q10 supplementation (Lonnrot K et al. Biochem Mol Biol Int 44(4):727-37, 1998).
To determine if Q10 has a neuroprotective effect, mice were first treated with Q10 or a control diet for four weeks. Then their striatal nerves were poisoned 1-Me-4-Ph-1,2,3, tetrahydropyridine (MPTP). The mice continued on their assigned diets for another week before sacrifice. Both groups had considerable damage; however, the Q10-treated mice had 37% higher dopamine and 62% more dense neurons, indicating a protective effect of Q10. (Beal MF et al. Brain Res 783(1):109-14, 1998.
Q10 also blocks the effects of doxorubicin, which stimulates mitochondrial oxidant production and a marked increase in mtDNA deletions in cardiac tissue (Adach

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