Nutritional supplement composition and use

Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Conjugate or complex

Reexamination Certificate

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C424S439000, C424S639000, C424S641000, C424S702000, C426S072000, C426S541000, C426S590000, C426S648000

Reexamination Certificate

active

06270774

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to nutritional supplements to the human diet, and more specifically to nutritional supplements which contain a combination of naturally occurring substances such as vitamins and minerals, antioxidants, barley grass extract, and ginkgo biloba extract.
2. Background
Diets complete in nutritional substance are important for the human body in order to afford consistent high levels of optimum performance, both in cognitive ability and physical health. Although the exact needs of the human species to develop and maintain peak performance on a daily basis and sustain such performance for the duration of the human life are not completely understood, it is widely recognized that maintaining balanced nutrition coupled with sensible levels of daily exercise are the fundamental bases for optimizing the condition of the human body. It is also widely accepted that the risk of many common ailments from environmental sources or many ailments arising from genetic consequences can be reduced through the daily practice of, in addition to exercise, a complete nutritional regime fortified with certain vitamins, minerals, food and herb concentrates, especially, in the case of certain genetic consequences, during the antenatal period. Increased human longevity is understood to be a potential consequence of these daily practices.
Cardiovascular disease resulting from the buildup of arterial plaque is a leading cause of illness or death. Arterial plaque is precipitous material formed chiefly of oxidized low density lipoprotein (O-LDL). The buildup of plaque in the form of O-LDL in the arteries is understood to be a factor in ischaemic heart disease. Free radical oxidants, many of which come from naturally occurring sources such as sun exposure, metabolism of certain nutrients, and exercise, act to oxidize low density lipoprotein (LDL) into its deleterious form, O-LDL. Free radical “scavengers” such as vitamins A, E, C, and selenium are believed to react with these oxidants so that they are not available to form O-LDL, thus lowering the risk of arterial plaque deposits in blood vessels. In contrast, the presence of high density lipoprotein (HDL) in the body is understood to have beneficial health effects. Specifically, HDL is known to be a more soluble form of lipoprotein; hence its presence does not significantly contribute to the formation of arterial plaque. In addition, it is known that HDL is able to absorb plaque material and may thus directly reduce the amount of arterial plaque.
3. Description of the Background Art
Certain vitamins and minerals, antioxidants, and plant extracts are generally known to have beneficial health effects. For example, several beneficial aspects of antioxidants have been known for many years. Antioxidants are chemicals that react with free radicals, such as hydroxy radicals, to protect certain biological systems. The removal of free radicals from the body has been suggested to increase human longevity—specifically, the presence of antioxidants including superoxide dismutase (SOD), carotenoids, alpha-tocopherol, and uric acid is suggested to have a positive correlation with resistance to spontaneous autoxidation of tissues and oxidative damage to DNA in mammals [Cutler, R.,
Am. J. Clin. Nutr.,
53:373S-9S (1991)]. Antioxidants are also known to limit destruction of healing brain tissue by free radicals as shown by the method for resuscitating the brain using vitamins such as A, E and C or selenium [See, Klatz et al., U.S. Pat. No. 5,149,321 and PCT application PCT/US92/06681].
In addition to their antioxidant activity, vitamins A, C, and E are well known to have other beneficial health effects. For example, vitamin E is known to help maintain proper blood sugar levels. As another example, vitamin C is known to play an integral role in the integrity of connective and structural tissues in the body. Vitamin A is known to play a role in maintaining good vision as well as in growth and development. Hence, an adequate supply of these vitamins is essential in maintaining optimum health. The use of vitamins A, E, C and selenium has been proposed as a means to inhibit or prevent collagen cross-linking in human skin when used in combination with certain active peptides [See, Geoffrey et al., PCT application WO 90/06102].
Barley grass is known to be a rich source of highly. metabolizable vitamins and minerals such as vitamins A, B1, B2, B6, and C, potassium, magnesium, and zinc. In addition, barley grass also has a high concentration of the enzyme superoxide dismutase (SOD), which has been shown to have high levels of antioxidant activity. Barley grass is believed to be an important nutrient in the regulation of the digestive process because the micronutrients, enzymes (e.g., SOD), and fiber contained in barley grass are believed to improve intestinal function [D. Walsh et al.,
British J. Nutr.,
70:621-630 (1993)].
Ginkgo biloba has been a staple Chinese herbal ingredient for thousands of years, and is frequently recommended by Chinese herbal practitioners for coughs, asthma and acute allergic inflammations. There are many active organic compounds in ginkgo biloba, including Ginkgolide B which has been shown to be an active constituent of ginkgo biloba and which apparently works by interfering with platelet activating factor (PAF). PAF is known to have several biological functions, including induction of platelet aggregation, neutrophil degranulation and oxygen radical production, and increasing microvascular permeability and bronchoconstriction. It has been shown that by its inhibitory interaction with PAF, Ginkgolide B helps improve cerebral metabolism and protect the brain against hypoxic damage in laboratory animals with cerebral ischaemia [Kleijnen, J. and Knipschild, P.,
The Lancet,
340:1136-39 (1992)]. In addition, ginkgo biloba extract is licensed in Germany for the treatment of cerebral dysfunction, hearing loss resulting from cervical syndrome, and peripheral arterial circulatory disturbances with intact circulatory reserve (intermittent claudication) [See, Kleijnen, J. and Knipschild, P., cited above]. Other studies indicate the efficacy of using ginkgo biloba extract to improve mental acuity [See, e.g.,
Nutrition Today
, Jul./Aug.:11-18 (1988);
Ginkgo Biloba Extract in Perspective
, Auckland, New Zealand: ADIS Press Limited:1 ff (1990))].
A healthy balance of vitamins and minerals has been known to be critical to sustain a healthy human body. Many combinations of vitamins and minerals have been taught over the years as food supplements beneficial to human health, and the daily ingestion of fruits and vegetables has long been recognized as critical to a healthy diet.
There remains a need in the art for novel daily food supplements that provide high levels of antioxidant activity, and thereby increase cardiovascular fortitude, maintain proper blood sugar balance, support mental awareness and intellectual performance, reduce the risk of digestive problems, and strengthen connective and structural tissues.
SUMMARY OF THE INVENTION
The compositions of the present invention are novel combinations of selected ingredients that are known to benefit the human organism. More particularly, the nutritional supplements of the present invention provide a novel combination of antioxidants, other vitamins, minerals, barley grass extract and ginkgo biloba extract. This unique combination of nutrients provides for improved nutrition when ingested by humans.
It is therefore an object of the invention to provide novel compositions containing a combination of specific antioxidants, other vitamins, minerals, a barley grass extract and ginkgo biloba extract.
The present invention also teaches the use of these compositions to supplement the human diet. Therefore, it is an object of the invention to provide a novel method of supplementing the human diet using the dietary supplements taught herein.
It is a further object of the present

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