CA2168441A1 - Nutritional supplement for optimizing cellular health - Google Patents

Abstract

A nutritional supplement, functioning as a food for special dietary use, enhances diets and assists persons recovering from addiction to health damaging substances. Since cellular damage and deficiencies occur and continue to exist even after the person has stopped abusing the substances, use of the nutritional supplement, which contains a variety of minerals, vitamins, herbs, amino acids, and other substances and nutrients, should be continuous. The nutritional supplement consists of a mixture of nutrients which cooperate synergistically in enhancing cellular metabolic pathways and assists in normalization of cellular functions and optimization of cellular health.

Description

~ W095/29668 21~ 4 ~ ~ PCT~S94/04731 NUTRITIONA~ 8~PPLEMENT FOR OPTIMIZING CE~L~LAR HEA~TH

Field of the Invention 3 This invention relates to a nutritional 4 supplement, which assists a person addicted to alcohol, drugs, tobacco, sugar or the like in recovery from such an 6 addiction.

8 ~ackqround of the Inventio~
9 It is known that some humans may abuse substances such as alcohol, marijuana, cocaine, heroin, tobacco, or 11 other substances. It is also known that abuse of such 12 subst~nç~c results in humans having compulsive disorders, 13 which include but are not limited to alcoholism, addictions 14 to marijuana, tobacco, cocaine, heroin, caffeine, sugar, or the like. These compulsive disorders cause changes in the 16 metabolism of human cells in such a way that metabolic 17 voids or errors in metabolism occur. These cellular 18 changes produce an addictive state which expresses itself 19 as the compulsive disorder. This compulsion is created by the cellular changes which makes the human crave the 21 addictive substance. Thus, substance abuse results in 22 adverse cellular metabolism which compromises health in the 23 human addict.
24 Substance abuse affects cellular metabolism throughout the human body. The human liver is generally 26 one of the first organs affected. This is especially 27 important because the liver is a highly active, vital organ 28 which has been termed the "metabolic capital" of the body, 29 performing over 400 essential bodily functions. For example, the liver performs bile synthesis and secretion 31 needed for fatty acid metabolism, while the liver's 32 vascular network and specialized cells filter and store 33 blood. The liver also contributes to carbohydrate 34 metabolism for conversion of galactose and fructose to WO9~/29668 PCT~S94/04731

2~8~

1 glucose, conversion of amino acid residues to glucose in 2 gluconeogenesis, formation and storage of glycogen in

3 glycogenesis and the formation of many important chemical

4 compounds from carbohydrate intermediates. The liver further performs fat metabolism which includes fat 6 conversion to transport form -- the formation of 7 lipoproteins; oxidation of fatty acids to acetoacetic acid, 8 then to acetylcoenzyme A(CoA) and into the citric acid 9 cycle to yield energy; formation of bile salts, cholesterol and phospholipids; and conversion of carbohydrate and 11 protein intermediates to fat through lipogenesis. The 12 liver still further performs protein metabolism which 13 occurs via deamination of amino acids; production of 14 lipotrophic factors for fat conversion to lipoproteins;
formation of plasma proteins; urea formation for removal of 16 ammonia from body fluids; and many amino acid 17 interconversions, transamination and amination and 18 synthesis of nonessential amino acids, purines, 19 pyrimidines, creatine, phosphate et al. Other related functions of the liver include storage of Vit~; n~ A, D, 21 B12 and other B complex Vitamins as well as Vitamin K;
22 production of blood coagulation factors from prothrombin in 23 the presence of Vitamin K, and from other blood factors 24 such as fibrinogen, accelerator globulin, and factor VII;
storage of iron as ferritin; conjugation and excretion of 26 steroid hormones; and detoxification of certain drugs 27 including morphine and barbiturates.
28 As a result of substance abuse, these functions 29 of the liver operate at a less than optimal level and possibly less than maintenance level. If the substance 31 abuse is prolonged or severe, such ailments as cirrhosis of 32 the liver may occur.
33 The next major organ affected by substance abuse 34 is the brain, which consists of tens of billions of cells that perform thousands of functions. The human brain is 36 the central organ for coordination and regulation of the 37 human body which controls speech, locomotion, behavior and ~ WO95/29668 21~ ~ 4 ~ ~. PCT~S94/04731 l a broad range of intellectual and emotional functions.
2 Unlike other human organs, the brain cannot regenerate a 3 cell once destroyed. The brain however, if properly 4 nurtured, can repair compromised brain cells, where, for example, compromised brain cells may result from 6 intoxication. In alcohol abuse many of the brain 7 structures are so eroded by the solvent effect of alcohol 8 that brains of alcoholics are not used in cadaver labs to 9 study brain structures.
If a human is abusing alcohol, cells within the 11 liver and brain may be damaged. For example, alcohol abuse 12 causes cellular damage to the brain and liver due to the 13 effects of ethanol and acetaldehyde build up in the 14 tissues. Ethanol is broken down by the enzyme alcohol dehydrogenase to acetaldehyde. This degradation process is 16 started in the liver. When acetaldehyde dehydrogenase is 17 depleted, a rapid build up of acetaldehyde occurs, which is 18 capable of producing THIQ (tetrahydroisoquinoline) a false 19 neurotransmitter that interferes with thought processes.
Toxification of specific enzyme systems occurs when 21 nutrient deficits at the cellular level permits the 22 beginning of destructive cellular changes. Destructive 23 cellular changes alter cell functions in ways that 24 eventually lead to more frequent use and greater quantities of the addictive substance(s) resulting in a psychological 26 and/or physical dependency.
27 Although Alcoholics Anonymous and other programs 28 treat the addiction, they do not address the physical 29 changes on the cellular level. Such programs may do a very good job of addressing many of the addict's social, 31 spiritual and some of the psychological reasons for the 32 addiction. Cellular deficits of nutrients are not 33 discussed nor addressed by the programs nor by other 34 methods of counseling.
Treatments for alcoholics, drug addicts, smokers 36 and/or like persons addicted to harmful substances have 37 heretofore included relatively large dosages of Vitamins 21~84~1 W095/29668 PCT~S9~/04731 1 such as Vitamin Bl, Niacin, L-Glutamine or other factors 2 individually or in cambinations of one or two items at 3 relatively high dosages. In these treatments, the 4 nutrients are used as if the cells were deficient in only one or a few nutrients. When deficiencies occur, they 6 generally occur in many areas simultaneously. Excessive 7 use of one or more nutrients may alter cellular 8 biochemistry in some undesirable ways that overwhelm or 9 compromise the benefits. These treatments fail to normalize and optimize metabolic pathways in the addictive 11 individual because they address only a portion of the 12 cellular metabolic needs, often at the expense of others.
13 While it is known that the addict relies on the addictive 14 substance(s) as a substitute for a nutritional diet and soon experiences losses in healthy cells especially in the 16 brain, lung, liver and/or pancreas it must be recognized 17 that withdrawal from the addictive substance(s) requires 18 the opening up of normal metabolic pathways to the vital 19 organs in a manner that will biochemically build up the damaged cells of the brain, liver, adrenal, kidneys, 21 pancreas and/or other organ tissues.
22 Cellular deficiency of a substance abuser has 23 been addressed to a very limited degree. For example, some 24 nutritional therapies have been developed to address one or more nutritional deficits. ~lkon;l was a product utilizing 26 niacin, Vitamin C and glutamine at a dose of one gram each 27 per tablet. Although this produced benefits in the 28 alcoholic, it addressed too few of the metabolic 29 compromises in the addict to be truly effective. For example, minerals and B Vitamin needs are not addressed, 31 leaving a constellation of nutritional deficits in the 32 addict.
33 Standard medical procedures usually treat one or 34 more signs or symptoms of alcoholism during crisis. Such treatments may include use of intravenous magnesium for 36 delirium tremens; or treat the early stages of cirrhosis of 37 the liver with drugs. This type of treatment does not 2~8441 WO95/29668 PCT~S94/04731 1 address the cellular deterioration as happens to the Ito 2 cells of the liver which become fat storage depots. Many 3 of these treatments are useful in crisis intervention and 4 addressing the effects of substance abuse, yet do little to treat the cause of substance abuse or restore normal 6 cellular metabolism.
7 Therefore, a need exists for a comprehensive 8 nutritional supplement that effectively treats both the 9 general and specific nutrient cellular deficits and subcellular nutritional requirements for normalization and 11 optimization of health at the cell level first, and 12 eventually the health of the whole organism itself - the 13 human addict.

SummarY of the Invention 16 The cellular needs discussed above and others are 17 substantially met by the nutritional supplement of this 18 invention, that is a nutritional supplement for special 19 dietary use. The nutritional supplement of this invention, which assists a human organism with a cellular metabolic 21 deficiency, is comprised of appropriate amounts of 22 nutrients for the repair and normalization of the cells and 23 cellular pathways of the human body to thereby return the 24 body to a normal or substantially normal operation.
The functioning of the nutritional supplement in 26 this invention is further elucidated in three drawings as 27 follows:

29 Brief Description of the Drawinqs FIG. 1 illustrates the basic content of a typical 31 human cell.
32 FIG. 2 illustrates a typical cellular chemical 33 reaction.
34 FIG. 3 illustrates cellular metabolism in humans.
36 Best Mode for CarrYing Out the Invention 37 FIG. 1 illustrates an elementary diagram of a W095/29668 PCT~S94/04731 1 typical human cell (100). the typical human cell (100) 2 comprises a plurality of secretion vacuoles (101), a 3 plurality of lipid droplets (102), a plurality of golgi 4 apparatus (103), a plurality of centriole (104), a nucleus (105), at least one endoplasmic reticulum (106), a 6 plurality of mitochondrion (107), and at least one plasma 7 membrane (108). Regardless of which organ the cell is part 8 of, each cell has the basic structure of FIG. 1 and has 9 generally similar nutritional needs. For example, cells (100) obtain nutrients from fluid between the cells via the 11 mitochondria (107). The mitochondria (107) extract energy 12 from nutrients and treat the energy released by oxidative 13 processes and the simultaneous formation of the high-energy 14 chemical bonds of ATP (adenosine triphosphatase). The nucleus (105) is characterized by its high content of 16 chromatin, which contains most of the cellular DNA
17 (deoxyribonucleic acid). The golgi apparatus (103) 18 produces and maintains their internal membrane -- the 19 endoplasmic reticulum (106). Closely associated with the inner surface of the endoplasmic reticulum (106) are 21 numerous granules rich in RNA (ribonucleic acid) termed 22 ribosomes (not shown) -- the site of protein synthesis 23 within the cell. The reticular system is most highly 24 developed in the liver and pancreas where cells (100) are actively engaged in the production of proteins. Lysosomes 26 (not shown) are subcellular organelles which contain 27 digestive enzymes that break down fats, proteins, nucleic 28 acids and other large molecules into smaller molecules 29 capable of being metabolized by the enzyme systems of the mitochondria (107). The health of the lysosome depends on 31 the lipoprotein membrane (108) remaining intact. Once the 32 membrane is ruptured by, or is in the presence of a 33 solvent, such as alcohol, release of lysosomal enzymes is 34 quickly followed by dissolution (lysis or death) of the cell.
36 FIG. 2 illustrates a schematic representation of 37 cellular metabolism (200) that occurs at the cellular and ~ WO95/29668 2 1 ~ 8 ~ 4 ~ PCT~S94/04731 1 subcellular levels in a human. The cellular metabolism 2 (200) comprises a chemical reaction (201) which produces a 3 desired cellular result (202).
4 For the chemical reaction (201) to efficiently occur, at least one enzyme (203) which acts as a catalyst 6 for the chemical reaction (201) must be present. However, 7 for proper enzyme catalysis, at least one enzyme stimulus 8 (204) and at least one enzyme co-factor (205) must also be 9 present. The enzyme stimulus (204) stimulates enzyme catalysis, while the enzyme co-factor regulates the 11 chemical reaction (201) at an approximately normal 12 metabolic rate. The cellular metabolism (200) may further 13 comprise an enzyme producer (206) that produces enzymes 14 (203). As an example, a healthy metabolic reaction (200) may comprise a chemical reaction (201) of combining 16 magnesium, glutamic acid, and NH4 to produce the desired 17 cellular result (202) of glutamine and NH3. NH3 can be 18 disposed of via the urinary tract after it is picked up in 19 the portal circulatory system and deposited in the kidney.
This process is a major detoxifier of protein residue that 21 otherwise accumulates in the liver and other tissues.
22 Dur:ing incomplete breakdown of proteins, free ammonia (NH4) 23 can build up in tissue, causing further cellular damage.
24 As can be seen in FIG. 3, the pyramid of cellular metabolism in human (300), it is important to note that 26 both diet and environment (301) influence enzymes (302), 27 intermediary metabolites (303), hormones (304), 28 biochemistry (305) and performance (306) sequentially 29 before symptoms (307) or signs (308) become obvious. An important fact at this point is that although signs (308) 31 and symptoms (307) are the bedrock of differential 32 diagnosis with either invasive organisms (infective 33 disease) or trauma (injury), contemporary medicine is not 34 designed to deal effectively with cellular metabolic change.
36 Tragically, patients are often dismissed as 37 neurotic when they complain of multiple and non-specific W095/29668 PCT~S94/04731 ~
,~ .

1 symptoms or signs. However, once a physician is able to 2 change perspective and views the individual from the 3 cellular level up, the symptoms and signs are confirmation 4 of cellular metabolic changes which will affect performance. A healthy liver cell, for example, has more 6 than 400 functions to perform. If the liver becomes 7 compromised or if utilization of abundant nutrient is not 8 ;~mc~iately available, then liver function suffers and 9 eventually the patient suffers. This condition is intensified by the ravages of addiction.
11 Much the same can be said for the adrenal gland 12 where adrenalin permits a person to respond to emergencies 13 and the mineralocorticoids are important factors in 14 maintaining normal cellular function. Whenever a person is under physical or psychological stress the adrenal glands 16 get a heavy work-out. In addition, the glands are 17 overwhelmed allowing fatigue to set in and a wide variety 18 of symptoms to appear.
19 The brain, on the other hand, along with the eyes represents about 2% of a person's body weight, yet require 21 over 25% of daily body nutrition. Glucose is the body 22 sugar used as a primary brain fuel and is consumed 23 continuously. Of great importance are two other fuels 24 which are oxidized in the brain, namely niacin/niacinamide and glutamic acid. Niacin/niacinamide is the building 26 block of NAD, NADH, NADPH, and niacinamide bridge reactions 27 necessary for normal brain metabolism. Glutamic acid 28 arrives at the blood/brain barrier as glutamine where it 29 loses an amine, becoming glutamic acid on entering the brain. These are important fuels that some therapists used 31 in megadoses with alcoholics and drug addicts. Although 32 these megadoses have often proved useful, they both address 33~ too few of the cellular metabolic weaknesses involved and 34 require much larger doses than would be necessary if most or all the metabolic needs were addressed.
36 In an addict, the abused substance(s) affect the 37 enzymes, hormones and biochemistry of the cell. These ~ WO95/29668 21 6 8 4 ~ ~ PCT~S94/04731 1 affects can be observed by changes in performance. For 2 example, in catalysis of an enzyme (see drawing 2), it is 3 critical to have adequate supplies of enzyme stimuli (204) 4 and enzyme co-factors (205) and other nutrient substrates for normal metabolism to occur. When alcohol or drugs are 6 abused, many of these nutritional substances are used up in 7 attempting to neutralize the abused substance, thus leaving 8 a deficit of nutrients at the cell level for normal 9 metabolism. In time, these subclinical deficits alter metabolism in such a way that cravings occur which foster 11 further abuse of the substance which, in turn, is needed 12 more and more fre~uently.
13 When alcohol is the abused substance, certain 14 metabolic and adverse metabolic processes take over so that even normal food material and sufficient sugar permit the 16 body to produce its own alcohol. This unhappy situation 17 further aggravates the recovery process by causing the 18 patient to relapse in an otherwise healthy rehabilitation 19 program. For example, if the person is addicted to beer --the hops, barley or other grains ingested, along with 21 several teaspoons of sugar -- can set off a cellular 22 reaction similar to the consumption of beer itself. The 23 same is true for rye whiskey, where rye bread and sugar --24 in coffee or sugared soda -- can trigger an extreme craving for rye whiskey even though it would appear that the 26 recovery process is proce~;ng normally.
27 Thus, the nutritional supplement comprises at 28 least one enzyme activating substance and at least one 29 enzyme co-factor. The enzyme activating substance, which may be a mineral such as magnesium, is supplied in 31 sufficient amounts to supplement the dietary input such 32 that normalizing some of the enzyme systems begins. For 33 example, reconstitution of ATP (adenosine triphosphatase) 34 from ADP (adenosine diphosphate) is a magnesium dependent process which can readily restore itself as long as 36 sufficient magnesium exists at the cell level. The RDA
37 (recommended dietary allowance) for magnesium is 400 mg in ~8~
W095/29668 PCT~S94/04731 1 the adult. A good American diet supplies about 250 to 300 2 mg per day. It will further take at least 200 to 400 mg of 3 magnesium in supplemental form to overcome the loss 4 traceable to the abused substance.
There is no danger of magnesium overdose since 6 the minimum toxic dose of magnesium, with the exception of 7 kidney failure or the like, is generally accepted to be 8 12,000 mg per day. Doses in high ranges, however, reduce 9 the body's absorption of the nutrient. It is important, therefore, to supply magnesium at a more reasonable dose to 11 optimize function at the cell level.
12 The enzyme co-factor, which is a Vitamin, such as 13 thiamine (Vitamin B1) and pyridoxine (Vitamin B6), is 14 needed in sufficient amounts along with magnesium to normalize specific enzymes. For example, thiamine is a co-16 factor with magnesium in controlling the rate of 17 lipogenesis (cellular fat generation). There is usually an 18 increase of lipid (fat) and cholesterol in the liver and 19 kidney of magnesium and thiamine deficient rats. The hypothesis is that the lipogenic pathways are activated by 21 blockage of the enzyme pathway to the citric acid cycle.
22 Of special interest in treating alcoholism, 23 thiamine and magnesium appear to be factors in acetaldehyde 24 accumulation from use of alcohol via the ~h;Arine dependent step in the metabolic pathway where acetaldehyde goes to 26 pyruvate (6). Supplementation of thiamine along with 27 magnesium permits more normal cellular metabolism of these 28 and other such enzyme activities allowing an approximately 29 normal metabolic rate to be re-established over a relatively short period (30 to 90 days minimum). After an 31 initial period of moderate supply of these nutrients, the 32 intake can be reduced while still maintaining fairly 33 efficient cellular enzyme functions. Thiamine is also a 34 factor in carbohydrate and glucose metabolism which further assists in reducing the sugar cravings of many addicts.
36 The nutritional supplement may further comprise 37 an enzyme producer such as an amino acid like glutamic W095/29668 21~ ~ fi 4 1 PCT~S94/04731 .

1 acid. Glutamic acid is a substrate used along with 2 magnesium and the by-product of protein catabolism NH4 to 3 produce NH3 and glutamine. NH3 is the reduced ammonia form 4 which is readily disposed of via urine while NH4 is free ammonia which can toxify or harm normal metabolism. The 6 incomplete breakdown of proteins which produces NH4 is 7 often increased by substance abuse. Glutamic acid is one 8 of the three oxidizable brain fuels along with glucose and 9 niacin/niac; n~ . Thus a supply of glutamic acid, an amino acid, provides a catalyst for at least part of the 11 cellular chemical reaction which permits degradation of 12 harmful NH4 to NH3 for removal via urine.
13 The nutritional supplement should also comprise 14 an herbal antispasmodic substance, such as Valerian root, in sufficient amounts to normalize the nutritional 16 substrates of the neuronal pathways permitting the human 17 organism to normalize at least one of the sub-cellular 18 ligand binders or cementous aspects of normal cells 19 allowing these metabolic functions to become more normal.
There are many other aspects of normalization of metabolic 21 factors and nutritional substrates beyond ligand binders 22 and various sub-cellular cementous substances including 23 collagen formation and utilization of cholesterol in the 24 white matter of the brain and inside the nerve sheath along with cellular bioelectric factors.
26 The enzyme co-factor of the nutritional 27 supplement should comprise water soluble vitAm; n~ such as 28 B VitAm;nc which contribute to normalize cellular metabolic 29 rates. The B vitAri nc permit completion of the enzyme reaction once it is activated by a specific mineral. For 31 example, niacin as NADH is reduced to NAD. Fat soluble 32 Vitamins include the antioxidant VitA~; n~ A, D and E which 33 assist in control of the rate of burning of the enzyme. If 34 an enzyme burns or oxidizes too rapidly, less cellular work is accomplished and free radical pathology may be promoted.
36 For example, Vitamin A is a factor in the collagen 37 synthesis of the Ito cells in the liver. When Vitamin A

21~4~
W095/29668 - PCT~S94/04731 1 levels are reduced in the Ito cells by ethanol, the cells 2 are changed to fat storage depots in the early stages of 3 liver cirrhosis. When Vitamin A deficiency occurs in the 4 liver then fibrosis can no longer be controlled, which adds to existing free radical pathology.
6 The enzyme activating substance should be 7 magnesium which activates more than 70% of the enzymes in 8 the human organism (8) including production and transfer of 9 energy, muscle contraction, protein synthesis and nerve excitability. Alcohol and other drugs reduce the amount of 11 magnesium available for normal metabolism as some is 12 diverted for detoxification and degradation of these 13 substances within cells.
14 The enzyme activating substance should also comprise zinc which encourages complete protein digestion 16 by activating thiol and carboxyl proteases. Alcohol abuse 17 interferes with normal protein digestion. Incomplete 18 breakdown of proteins in turn allows free radical damage to 19 the cell. The nutritional supplement may also contain chromium which, in conjunction with manganese, encourages 21 complete and functional carbohydrate metabolism.
22 Normalization and control of blood sugar levels are 23 partially dependent on the functions of manganese and 24 chromium in carbohydrate metabolism.
The nutritional supplement should still further 26 comprise Vitamin C which is a factor in the structure and 27 function of collagen tissue and is also part of the fibrin 28 net necessary for healthy cardiac muscle tissue. One of 29 the first structures to disappear in compromised cardiac muscle is the fibrin net. It is important to note that 31 while the level of Vitamin C is higher than the RDA, it is 32 necessary to fulfill the increased requirements of the 33 addict, and does not approach the so called megadose range.
34 The nutritional supplement or substance addiction recovery supplement is used in recovering from the cellular 36 damage caused by the addictive process. The addicting 37 substance(s), whether alcohol, drugs, tobacco, or other ~ WO95/296G8 21 6 8~ 4 .~ PCT~S94/04731 1 substances, actively uses up various nutritional factors 2 such as nutritional substrates supplied by an herb; amino 3 acids supplied by glutamic acid or other amino forms;
4 chelated magnesium, zinc, manganese, chromium or other minerals (these minerals may be chelated with glycine or 6 other organic amino compounds); thiamine, pyridoxine or 7 other water soluble B Vit~mi n~; Vitamin A or other fat 8 soluble Vitamins; Vitamin C as a component of healthy 9 collagen or other t;CCll~; choline that is a lipotrophic factor improving fatty acid metabolism and inositol to 11 maintain availability of the substrate muscle sugar in the 12 compromised tissue of an addict. The substance addition 13 recovery supplement or nutritional supplement is needed to 14 resupply these nutrients in addition to those available in the diet. This abundance, but not a megadose, is necessary 16 to help normalize cellular function and metabolic pathways 17 by providing a ready source of nutrients to an otherwise 18 compromised organism, first the damaged cells then the 19 human addict.
The cravings associated with addictions appear to 21 be a generalized response of the organism which has 22 developed one or more of the nutritional deficiencies 23 associated with addictive states. These cravings are 24 addressed in the substance addiction recovery supplement or nutritional supplement by supplying at least one enzyme 26 activating substance, which may be the mineral magnesium;
27 and at least one enzyme co-factor, which should be Vitamin 28 B1 and B6; Vitamin B12 and folic acid is also necessary.
29 The nutritional supplement may also comprise any or all of the following, nevertheless the best mode contemplates 31 using at least the following as a minimum treatment; at 32 least one amino acid; Vitamin C for normalization of 33 collagen tissue and the fibrin net of cardiac muscle as 34 structural components and other cellular functions; other substances found necessary to restore the body cellular 36 functions to normal are Vitamin A, beta-carotene, 37 niacin/niacinamide, Vitamin C, zinc, and valerian root.

2`1~8~1 W095/29668 PCT~S94/04731 1 When the nutritional components, minerals, 2 Vitamins, amino acids, and herbs as set forth above, are 3 supplied to an addict, the human body is able to resume a 4 more normal cellular biochemical function, decreasing the need for the addictive substance(s). This combination of 6 substances for special dietary use is nec~csary to address 7 the nutritional deficiencies and/or errors of metabolism 8 created by the use and/or abuse of an addictive substance.
9 A synergistic group of nutrients can be successfully assembled to supply the basic cellular needs 11 in specific or generalized deficiency conditions. In 12 addictive states there are a number of areas that must be 13 addressed in order to provide a food for special dietary 14 use that answers cellular needs and permits normalization or optimal nutrition. When such a group of nutrients are 16 made available to the cells, an optimum effect occurs, 17 wherein the whole can be greater than the sum of the parts.
18 In this instance no individual nutrient generally meets the 19 cellular needs of the addictive individual as effectively as the synergistic aspects of the above combination of 21 substances. The effects can be enhanced by using all of 22 the elements mentioned above taken as a nutritional 23 supplement. This synergistic combination of nutrients 24 includes, but is not necessarily limited to, specific chelated minerals with their Vitamin co-factors such as 26 chelated magnesium (such as magnesium glycinate) with 27 Vitamins Bl, B2, B6, niacin/niacinamide, B12, folic acid, 28 biotin and pantothenic acid; chelated zinc (such as zinc 29 glycinate) for specific liver enzyme factors; chelated manganese (such as manganese glycinate) and/or chromium 31 (such as chromium glycinate) for carbohydrate metabolism;
32 Vitamins A, D (as Vitamin D3), and E as fat soluble Vitamins 33 and antioxidants; Vitamin C as an aspect of structural 34 integrity of collagen and other cellular structural and functional requirements; glutamine and/or glutamic acid 36 with chelated magnesium (for the degradation of NH4 to NH3 37 and glutamine) for detoxification of free ammonia at the 2i684~
_ W095/29668 PCT~S94/04731 1 cell level: nervine and/or antispasmodic herbs such as 2 valerian root or other herbs to nourish, normalize and 3 optimize the nutritional substrates and neuronal pathways.
4 Through this invention, nutrients, balanced synergistically with each other, are provided to effect 6 ben~ficial changes at the cellular level. These changes 7 will optimize healthy cellular functions for the addict, 8 thus lessening the need and/or desire for the addictive 9 substance(s).
When using a specific group of nutrients, as in 11 this invention, it is imperative to note the optimal 12 nutrient contents of the assembled nutrients and to 13 understand their synergistic nature. Thus, the combination 14 of nutrients combine for an effect where the combination is greater than any individual nutrient. There is an 16 effective range for each of the individual nutrients used 17 in this invention with a specific level chosen to foster 18 the optimum interaction of all of the parts, thus forming 19 a synergistic complex which is capable of producing an optimum effect which will result in an overall reduction of 21 craving for the addictive substance(s).
22 Since the addictive process is not identical for 23 all individuals, the substances supplied by the subject 24 invention is designed to supply the needed nutrients for normalizing cellular metabolic pathways in the greatest 26 number of individuals with minimal cost to the patient.
27 This product is further designed to be used in conjunction 28 with existing alcohol and/or drug treatment programs to 29 increase their effectiveness and to decrease recidivism or the rate of relapse. The nutritional supplements of the 31 subject invention should be different for each addiction.
32 However, regardless of the addiction, there are some 33 primary nutrients necessary in all cases, while others are 34 supportive and specialized for each different addiction.
Vitamins C and A, Beta Carotene, niacin, niacinamide, and 36 the herb Valerian Root may be found in all formulas. The 37 smoking cessation supplement should comprise higher levels 216~
W095/29668 PCT~S94/04731 1 of VitA~in~ c and e, selenium, zinc, and may include 2 minerals such as cooper and calcium while adding the herb 3 Echinachea and possibly others. The supplement for 4 alcohol treatment programs should comprise higher levels of magnesium, Vitamins B1, B6, B12, and folic acid; minerals 6 manganese, chromium; the amino forms glutamic acid and 7 glutamine with perhaps others.
8 Other specialized supplements for assisting in 9 food addictions such as with sugar, chocolate, or salt, may have different levels of magnesium, chromium, manganese, 11 zinc, and Vitamins A and C but will not be limited to these 12 changes as additional herbs, amino forms, or other Vit~inc 13 and minerals may be useful in this supplement.

PRIMARY NUTRIENTS
16 Low Hiqh OPtimum 17 Magnesium 50 mg 1000 mg 150 mg 18 Zinc 10 mg 100 mg 30 mg 19 Vitamin A 1000 IU 15000 IU 4500 IU
Beta Carotene 5000 IU 45000 IU 15000 IU
21 Vitamin C 100 mg 10000 mg 600 mg 22 Vitamin Bl 10 mg 300 mg 100 mg 23 Vitamin B6 50 mg 1000 mg 150 mg 24 Vitamin B12 30 mcg 300 mcg 90 mcg Niacin 10 mg 500 mg 60 mg 26 Niacinamide 100 mg 2000 mg 300 mg 27 Valerian Root 50 mg 1000 mg 150 mg 31 Calcium 100 mg 5000 mg 500 mg 32 Chromium 20 mcg 500 mcg 60 mcg 33 Copper 1 mg 20 mg 5 mg 34 Iron 5 mg 100 mg 20 mg 35 Manganese 5 mg 100 mg 15 mg 36 Selenium 20 mcg 400 mcg 200 mcg 37 Vitamin D3 100 IU 1000 IU 300 IU

2~8~41 W095/29668 PCT~S94/04731 1 Vitamin E 10 mg 800 mg 30 mg 2 Vitamin B2 5 mg 100 mg 30 mg 3 Biotin 100 mcg 1000 mcg 300 mcg 4 Pantothenic Acid 50 mg 500 mg 150 mg Choline 50 mg 900 mg 300 mg 6 Inositol 100 mg 1000 mg 300 mg 7 Glutamic acid 50 mg 1000 mg 150 mg 8 Glutamine 50 mg 1000 mg 150 mg 9 ~chinAchea 50 mg 1000 mg 150 mg 11 Other amino forms such as alanine, arginine, aspartic 12 acid, asparagine, cystine, cysteine, cystathionine, 13 glycine, histidine, isoleucine, leucine, lysine, 14 methionine, proline, phenylalanine, serine, threonine, tryptophan, valine or others, may be used.
16 Other herbs such as comfrey, catnip, cayene, dong 17 quai, walnut, black coho~h, wood betony, kava kava, ginger, 18 gota kola, garlic, ginsing, slippery elm, skullcap or 19 others, may be used.
Other minerals may be used, such as potassium, boron, 21 molybdenum, lithium, iodine, germanium, rubidium, silicon, 22 and vanadium.
23 Possible minor modifications of nutrient levels or 24 minor additions or deletions may be made in individual 2S cases as may prove more beneficial in approaching the 26 nutritional optimum under clinical and/or research 27 conditions. The optimal dosage for bringing the cell to 28 viability in the shortest time period is contemplated to be 29 orally ingested daily for at least 90 days and possibly longer, with a maintenance dose comprising the lower dosage 31 set forth on a daily basis. The biochemical individuality 32 of a given addict may require the highest dose (set forth) 33 for an initial period of 10 to 90 days; or may require only 34 ~i n; ~1 treatment.
While the above formulation is optimal in most 36 circumstances in aiding recovery from addictive conditions, 37 it is possible with a different formulation, to achieve W095/29668 PCT~S94/04731 1 some success in more limited circumstances and with less 2 dramatic success.
3 The following examples are indicative of optimal 4 formulations for smoking, alcoholism, and the various food addictions. Each example includes all of the primary 6 nutrients set forth above with only the dosage changes 7 indicated.

Primary nutrients with the following differences:
11 Zn - 60 mg 12 Copper - 6 mg 13 Se - 200 mg 14 Higher Vitamin C - 1000 mg 16 Biotin - 400 mcg 17 Vitamin D - 400 IU
18 Vitamin E - 60 mg 19 Echinachea - 200-300 mg 22 Primary nutrients with the following differences:
23 Mg - 300 mg 24 B6 - 300 mg Cr - 60 mcg 26 Mn - lS mg 27 Vitamin D3 - 300 IU
28 Choline - 150 mg 29 Inositol - 300 mg Pantothenic 31 Acid - 150 mg 32 Glutamic Acid - 210 mg 33 Glutamine - 150 mg SWEETS AND JUNK FOOD ADDICTION
36 Primary Nutrients with the following differences:
37 Zn - 15 mg 38 Vitamin A - 1500 IU

W095/29668 ~ 1 G g ~ ~ ~ PCT~S94/04731 1 Bl - 30 mg 2 B12 - 30 mcg 3 Niacin - 30 mg 4 Niacinamide Lower - 150 mg 6 Cr - 60 mcg 7 Mn - 15 mg 8 Vitamin E - 30 mg 9 B2 - 15 mg Biotin - 100 mcg 11 Pantothenic 12 Acid - 60 mg 13 Glutamic Acid - 150 mg 14 Glutamine - 150 mg Echinachea - 150 mg 16 While the invention has been described with reference 17 to a preferred embodiment, it will be understood by those 18 skilled in the art that various changes may be made and 19 equivalents may be substituted for elements thereof without department from the scope of the invention. In addition, 21 many modifications may be made to adapt a particular 22 situation or material to the teachings of the invention 23 without departing from the essential scope thereof.
24 Therefore, it is intended that the invention not be limited to the particular embodiment disclosed as the best mode 26 contemplated for carrying out this invention, but that the 27 invention will include all embodiments and equivalents 28 falling within the scope of the appended claims.
29 Various features of the invention are set forth in the following claims.

Claims (24)

I CLAIM:

1. A nutritional supplement for oral administration for use in aiding the recovery of addicts to health by bringing cells to a healthy state and reestablishing normal cellular biochemistry comprising:
About 1500 IU to about 13500 IU Vitamin A;
About 5000 IU to about 45000 IU Beta-carotene;
About 10 mg to about 300 mg Vitamin B1;
About 50 mg to about 450 mg Vitamin B6;
About 30 mcg to about 270 mcg Vitamin B12;
About 20 mg to about 180 mg Niacin;
About 100 mg to about 900 mg Niacinamide;
At least about 200 mg Vitamin C;
About 50 mg to about 450 mg Magnesium;
About 10 mg to about 90 mg Zinc;
About 50 mg to about 450 mg Valerian Root;
At least two additional minerals selected from the group of calcium, chromium, copper, iron, manganese, and selenium; and At least four additional Vitamins, herbs, and amino acids selected from the group consisting of vitamin D3, Vitamin E, Vitamin B2, biotin, pantothenic acid, choline, inositol, glutamic acid, glutamine, and echinachea.

2. The supplement of Claim 1 including about 100-900 IU of Vitamin D.

3. The supplement of Claim 1 including about 100-90 mg of Vitamin E.

4. The supplement of Claim 1 including about 10-90 mg of Vitamin B2.

5. The supplement of Claim 1 including about 20-180 mcg of Biotin.

6. The supplement of Claim 1 including about 100-900 mg of Pantothenic Acid.

7. The supplement of Claim 1 including about 70-630 mg of Choline.

8. The supplement of Claim 1 including about 100-900 mg of Inositol.

9. The supplement of Claim 1 including about 70-900 mg of Glutamic Acid and 50-450 mg of Glutamine.

10. The supplement of Claim 1 including about 5-45 mg Manganese and about 10-30 mg Chromium.

11. The supplement of Claim 1 including Echinachea.

12. A method for aiding in the recovery of addicts by the oral administration of a nutritional supplement for utilization by cells to bring about health in a nonhealthy state and to reestablish normal cellular biochemistry comprising the step of orally administering the following elements on a daily basis for at least 30 days:
About 1500 IU to about 13500 IU Vitamin A;
About 5000 IU to about 45000 IU Beta-carotene;
About 33 mg to about 300 mg Vitamin B1;
About 50 mg to about 450 mg Vitamin B6;
About 30 mcg to about 270 mcg Vitamin B12;
About 20 mg to about 180 mg Niacin;
About 100 mg to about 900 mg Niacinamide;
At least about 200 mg Vitamin C;
About 50 mg to about 450 mg Magnesium;
About 10 mg to about 90 mg Zinc;
About 50 mg to about 450 mg Valerian Root;
At least two additional minerals selected from the group of calcium, chromium, copper, iron, manganese, and selenium; and At least four additional Vitamins, herbs, and amino acids selected from the group consisting of Vitamin D3, Vitamin E, Vitamin B2, biotin, pantothenic acid, choline, inositol, glutamic acid, glutamine, and echinachea.

13. The supplement of Claim 12 including about 100-900 IU of Vitamin D.

14. The supplement of Claim 12 including about 10-90 mg of Vitamin E.

15. The supplement of Claim 12 including about 10-90 mg of Vitamin B2.

16. The supplement of Claim 12 including about 20-180 mcg of Biotin.

17. The supplement of Claim 12 including about 100-900 mg of Pantothenic Acid.

18. The supplement of Claim 12 including about 70-630 mg of Choline.

19. The supplement of Claim 12 including about 100-900 mg of Inositol.

20. The supplement of Claim 12 including about 70-900 mg of Glutamic Acid and about 50-450 mg of Glutamine.

21. The supplement of Claim 12 including about 50-450 mg Magnesium and about 10-30 mcg Chromium.

22. A nutritional supplement for oral administration for use in aiding the recovery of alcoholics to health by bringing cells to a healthy state and reestablishing normal cellular biochemistry comprising:
About 4500 IU Vitamin A;
About 15000 IU Beta-carotene:
About 100 mg Vitamin B1;
About 300 mg Vitamin B6;
About 90 mcg Vitamin B12;
About 60 mg Niacin;
About 300 mg Niacinamide;
At least about 200 mg Vitamin C;
About 200 mg Magnesium;
About 30 mg Zinc;
About 150 mg Valerian Root;
Chromium, Manganese, Vitamin D3, Choline, Inositol, Pantothenic Acid, Glutamic Acid, and Glutamine.

23. A nutritional supplement for oral administration for use in aiding the recovery of sweets and junk food addicts to health by bringing cells to a healthy state and reestablishing normal cellular biochemistry comprising:
About 1500 IU Vitamin A;
About 5000 IU Beta-carotene;
About 30 mg Vitamin B1;
About 150 mg Vitamin B6;
About 30 mcg Vitamin B12;

About 30 mg Niacin;
About 150 mg Niacinamide;
At least about 150 mg Vitamin C;
About 150 mg Magnesium;
About 15 mg Zinc;
About 150 mg Valerian Root:
Vitamin E, Vitamin B2, biotin, pantothenic acid, glutamic acid, glutamine, and echinachea.

24. A nutritional supplement for oral administration for use in aiding the recovery of smoking addicts to health by bringing cells to a healthy state and reestablishing normal cellular biochemistry comprising:
About 1500 IU Vitamin A;
About 5000 IU Beta-carotene;
About 30 mg Vitamin B1;
About 150 mg Vitamin B6;
About 30 mcg Vitamin B12;
About 30 mg Niacin;
About 150 mg Niacinamide;
At least about 1000 mg Vitamin C;
About 150 mg Magnesium;
About 60 mg Zinc;
About 150 mg Valerian Root;
Copper, Selenium, Vitamin D3, Vitamin E, Biotin, and Echinachea.