Note: Descriptions are shown in the official language in which they were submitted.
~ 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.
14
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:
28
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
12
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
14
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.
14
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
28
29 SECONDARY NUTRIENTS
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
4 4 1
W095/29668 PCT~S94/04731
18
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.
9 SMOKING ADDICTION
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
21 ALCOHOL ADDICTION
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
34
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.
