Nutrient therapy for immuno-compromised patients

Details Nutrient therapy for immuno-compromised patients Nutrient therapy for immuno-compromised patients

2001-08-10

2003-01-07

Witz, Jean C. (Department: 1651)

Drug, bio-affecting and body treating compositions

Enzyme or coenzyme containing

Stabilized enzymes or enzymes complexed with nonenzyme

C514S561000

Reexamination Certificate

active

06503506

ABSTRACT:

BACKGROUND OF THE INVENTION
Unfortunately there appears to be a growing number of people suffering from chronic debilitating diseases characterized by muscle tissue wasting, decreased energy and oxidative stress and immune impairment.
Most dramatic of such disease is the major increase in HIV presently infecting over 50 million people. Currently approximately 22 million people have died from the consequences of HIV induced Acquired Immune Deficiency Syndrome (AIDS). HIV attacks the human immune system, weakening the body and reducing the patient's ability to ward off opportunistic infections, ultimately rendering him/her defenseless against diseases that usually and under normal circumstances can be successfully treated. There is no cure for AIDS.
Over the years a sizable array of vaccines, antiretroviral drugs, such as AZT and other viral suppressive compounds, have been developed that seek to—if not defeat, at least control the rate at which HIV replicates and thereby slow the progression of the disease, or even arrest it. However, most of these drugs to be effective have to be taken in combination with complicated regimes that need to be followed meticulously and indefinitely. More importantly, the toxic nature of these drugs leads to further decreases in host defense, energy production and increases in oxidative stress furthering the development of the disease. These drugs are expensive and not affordable by many if not most HIV infected persons. Furthermore, even if available and affordable, there presently are no reliable data on the side effects of such long term therapy, or HIV's capacity to mutate into drug resistant strains.
To those infected with AIDS and many other chronic debilitating diseases, wasting syndrome is a very real part of their every day life. Wasting is the term used for the loss of lean muscle mass due to the virus placing additional nutritional demands on the body. These stresses can diminish appetite causing the body to use protein and other nutrients from muscle stores that help the body function correctly. As a result of this, muscles become smaller, weaker and less flexible. Eventually when muscle loss becomes significant, the ability for the body to function normally and combat other common infection greatly diminishes.
In recent years, a considerable amount of information on the spectrum of clinical consequences of HIV infection has been accumulated. The most striking characteristics of this disease include severe malnutrition and wasting syndrome. Such malnutrition involves both changes in overall body composition as well as deficiencies of specific nutrients. As HIV infection progresses to AIDS, a significant result is under-nutrition producing the added effects of starvation, a potent immuno-suppressant. Nutritional support could thus help maintain health in the HIV+ patient by replacing lost nutrients, compensating for nutritional damage done by the retrovirus-induced immunodeficiency, and stimulating the remaining immune system and cells for better host defenses. The medical community generally agrees that there remains an urgent need for interventions, including inexpensive nutrient therapies, which serve as an adjunct to current medical treatment for persons with HIV/AIDS (PWAs).
It has been shown that the course of infection is influenced by different factors including age, genetics, environmental, opportunistic infections, therapy and nutritional status. Among these, there is considerable evidence to suggest important links between nutrients, oxidative stress and HIV infection. Alterations of nutrients and increased oxidative stress associated with inadequate antioxidant intake have been observed in HIV infected subjects. Such nutrient depletions may influence immunological function, viral replication, carcinogenesis, development of cardiomyopathy and resistance to infection.
Additionally adherence is also an extremely important issue for nutritional supplements. If the product is distasteful or unpleasant to consume its use will not be repeated.
Unfortunately, there currently is no nutritional supplement on the market that addresses these major issues and conditions, such as oxidative stress, decreased lean muscle mass and weight, and mitochondrial failure (decreased energy production), associated with HIV/AIDS and other chronic debilitating diseases.
BRIEF DESCRIPTION OF THE INVENTION
The present nutritional support composition addresses the needs of those whose immune systems are compromised through HIV/AIDS and other chronic debilitating diseases through a multiprong approach designed to:
Decrease oxidation stress
Help restore lean muscle mass
Up-regulate/increase energy production (decrease mitochondria failure)
Support Immune System
Specifically the present composition comprises in combination:
1. Orally administrative superoxide dismutase (hereinafter referred to as SOD) in combination with a lipid or protein carrier derived from plants to serve as an antioxidant support.
Particularly preferred is the protein prolamine derived from cereals, and especially SOD/Gliadin.
The orally administrable SOD component may be supplemented by other antioxidant components—Beta Glucans, Nucleotides and Fruit Polyphenols.
2. A mitochondrial/energy support component selected from the group consisting of Coenzyme Q10, D-Ribose and L-Carnitine
3. A component for maintaining lean muscle mass comprising a member of the group Ornithine alpha ketoglutarate (OKG) and High Immunoglobulin Whey (undenatured whey), which may be supplemental by other components such as Branched Chain Amino Acids, Instantized Casein, and Glutamine.
In addition to the foregoing functions, SOD/Gliadin, Beta Glucans, Coenzyme Q10, Nucleotides, Glutamine and Undenatured Whey Protein also help to support immune function.
The present composition will not interfere with or react with current drug therapies for treating HIV/AIDS or cancer. It is easily miscible with water, milk or juices to completely dissolve. It is easily blendable with flavoring agents to overcome poor adherence plaguing other nutritional products. Flavors such as Dutch Chocolate, Wild Berry and Vanilla Honey Caramel have been produced.
While certain of the above components have been used therapeutically, the present invention distinguishes over such prior art by:
Providing a multicomponent system approach to treating chronic debilitating diseases, and
Providing the first orally bioavailable form of SOD in combination with other synergistic nutritional components
DETAILED DESCRIPTION OF THE INVENTION
1) Antioxidant Support
The primary agent is orally administrable superoxide dismutase (SOD) in combination with a lipid or protein carrier derived from plants. A detailed description of such an antioxidant will be found in U.S. Pat. No. 6,045,809 issued Apr. 4, 2000 whose specification is hereby incorporated by reference. Such SOD compositions have good bioavailability and are therefore therapeutically effective.
In one embodiment the proteins are selected form the group consisting of prolamines and polymer films based on prolamines. The prolamines are preferably of vegetable origin and can be obtained from different cereals, especially wheat, rye, barley, oats, rice, millet and maize. Particularly preferred is gliadin derived from wheat. SOD/Gliadin, which has recently become available commercially, is especially preferred in the instant composition.
In another embodiment, the plant lipids are preferably selected from the group consisting of ceramides, phospholipids tylacoids and diacylglycerols. Particularly desired are ceramides of vegetable origin derived from cereals, especially wheat.
SOD (Superoxide Dismutase)
In the past, SOD was a very popular supplement acting as a master cellular defense enzyme. Unfortunately, taking this supplement orally yielded little if any benefit since it is easily destroyed in the GI tract via digestive enzymes. Hence, the use of injectable SOD from bovine sources was the form of choice in most of the published studies. Today, after extensive research and development

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