DE202008009883U1 - Compositions for maintaining, enhancing, improving or supporting eye health - Google Patents

Abstract

A food or dietary composition comprising, on the basis of a daily dose:
a) α-lipoic acid in an amount of about 100 to about 500 mg or a pharmaceutical equivalent thereof;
b) phenol antioxidant compounds in an amount of about 100 to about 500 mg or a pharmaceutical equivalent thereof;
c) Vitamin C in an amount of about 50 to about 300 mg or a pharmaceutical equivalent thereof;
d) Vitamin E in an amount of about 5 to about 50 mg or a pharmaceutical equivalent thereof;
e) thiamine in an amount of about 0.5 to about 3 mg or a pharmaceutical equivalent thereof;
f) nicotinamide in an amount of about 5 to about 50 mg or a pharmaceutical equivalent thereof;
g) pyridoxine in an amount of about 1 to about 5 mg or a pharmaceutical equivalent thereof; and
h) chromium (III) in an amount of about 0.05 ...

Description

The The present invention relates to compositions and methods for preserving, strengthening, improving or supporting the eye health. In particular, the present invention relates on dietary or nutritional supplements and methods for obtaining, augmenting, improving or supporting Eye health in persons with certain eye diseases or are at risk of developing such. Especially The invention relates to compositions and methods for Receiving, Strengthening, Improving or Supporting Eye health in patients with diabetic eye complications or retinal degeneration or are at risk, to develop such.

Fundus diseases include the most common causes of loss of vision. There is increasing evidence that many ocular fundus diseases in oxidative stress of the retina are justified.

Under The ocular fundus diseases are diabetic retinopathy ("DR") the most common cause of blindness in adults, ages 18 to 72, who have diabetes. Diabetes is a chronic disease, and delayed Hyperglycaemia attacks both the microvessels as well as macro vessels within the body at. Diabetic retinopathy, a disease of the retina and complication in case of prolonged diabetic illness, is caused by damage on the vessels of the retina. The blood vessels, which normally provide the retina with nutrients, swell and lose fluid. If this condition is not interrupted or prevented, begin new vessels to grow, which eventually leads to a retinal detachment to lead.

It it is known that diabetes causes increased oxidative stress, which significantly contributes to the development of diabetic Complications contributes. It is believed that elevated oxidative stress the development of diabetic retinopathy promotes. The possible sources of oxidative Stress in diabetes include auto-oxidation of glucose, shift in redox equilibria, decreased tissue concentration of Low molecular weight antioxidants, such as. B. reduced Glutathione ("GSH") and vitamin E, and harmful Effects of enzymes that protect antioxidants, such as z. Superoxide dismutase ("SOD") and catalase.

Compared with other tissues, the retina has a high content of polyunsaturated fatty acids, a high concentration of photosensitizers and the highest oxygen uptake and glucose oxidation. These properties combined with intense exposure to light make the retina more susceptible to oxidative stress. From animal experiments it is suggested that the correlation between hypertension, changes in redox homeostasis and oxidative stress are the key events in triggering the disease DR. Furthermore, oxidative stress also helps to prevent retinopathy from regressing once good glycemic control has been restored. RA Kowluru and PS. Chan, "Oxidative Stress and Diabetic Retinopathy", Expt'l Diabets Res., Vol. 2007, art. ID 43603, doi: 10.1155 / 2007/43603 , In addition to the dietary or pharmacological agents for controlling glucose and blood pressure, laser photocoagulation is currently the main therapy for DR and is essentially indicated for all patients when retinopathy reaches more pronounced proliferative stages. Regrettably, this therapy is associated with side effects such. B. a decrease in peripheral vision and night vision and changes in color perception. Furthermore, in some cases, retinopathy continues despite timely and adequate laser photocoagulation. In rare, potentially severe circumstances, complications of laser therapy may also occur. LP Aiello, Surv. Ophthalmol., Vol. 47, S263 (2002) ,

Retinal degeneration, another degenerative disease of the fundus, is the most common cause of loss of central vision in 50-year-olds or older and their prevalence increases with age. Age-related retinal degeneration ("AMD") is the most common form of the disease, and the clinical manifestations of AMD include drusen, hyperplasia of the retinal pigment epithelium ("RPE"), central atrophy of the macula, and choroidal neovascularization. Three known risk factors for AMD are oxidative stress; Smoking cigarettes, exposure to sunlight and low levels of eye melanin. DM Snodderly, "Evidence for Protection Against Age-Related Macular Degeneration by Carotenoids and Antioxidant Vitamins," Am J. Clan Nutr., Vol. 62 (Suppl.), 14185 (1995). , The aging process inevitably leads to an increase in oxidative damage. The plasma levels of endogenous antioxidants such as. As glutathione, vitamin C and vitamin E decrease with age. The level of activity of the defensive, antioxidant enzymes in the RPE (Superoxidismutase, Catalase and Glutathione Peroxida se) also decrease with age. The susceptibility of RPE cells to oxidative stress is therefore increased in individuals predisposed to AMD due to mutations in two recently discovered genes that encode proteins in the complement system. There is currently no proven treatment that can slow or prevent the development of advanced AMD. Laser photocoagulation and photodynamic therapy in the neovascular form of this disease may limit the loss of vision in patients. However, these treatments are stressful for patients and their successes are unpredictable. Therefore, the prospect of the invention is very appealing from the public health point of view.

In the randomized, placebo-controlled, age-related, eye disease study ("AREDS") dietary supplements containing 5 to 13 times the recommended daily amount ("RDA") of beta carotene, vitamins C and E, and zinc were administered to participants from retinal clinics administered with early or monocular, later AMD, resulting in a 25% reduction in the five-year development to late AMD. AREDS Report No. 8, Arch. Opthalmol., Vol. 119, no. 10, 1417 (2001) , However, another study involving 1193 subjects between the ages of 55 and 80 found no statistically definite effect of daily dietary supplementation of 500 IU of natural vitamin E (335 mg D-α-tocopherol). HR Taylor et al., "Vitamin E Supplementation and Macular Degeneration: Randomized Controlled Trial," BMJ, Vol. 325, 11 (2002) , Although the results of the latter study have been disappointing, dietary supplements including antioxidants are still desirable for ocular health. Therefore, there is a continuing need to provide new dietary or nutritional supplements that can help to improve or strengthen eye health through simple procedures.

SUMMARY OF THE INVENTION

Generally The present invention provides a dietary or dietetic Supplement composition for administration to humans or other living beings that gets their eye health strengthens, improves or promotes.

According to one Aspect receives, strengthens, improves or promotes the dietary or dietary supplement composition the eye health of patients who have an eye disease or are at risk of developing one.

According to one In another aspect, the administration of a composition according to the present invention, the loss of visual acuity in patients prevent, stabilize, reverse with eye diseases make and / or treat.

According to one In another aspect, the administration of a composition according to the present invention, the loss of visual acuity in patients prevent with diabetic eye complications or retinal degeneration stabilize, reverse and / or treat.

According to one another aspect may be a dietary or dietary supplement composition The present invention can also be administered to complications diabetic retinopathy, diabetic macular edema or cataract to prevent, stabilize, reverse to do and / or treat.

According to one another aspect may be a dietary or dietary supplement composition of the present invention can also be administered to macular degeneration to prevent, stabilize, reverse make and / or treat.

According to one another aspect comprises a dietary or dietary supplement composition according to the present invention amounts of certain Antioxidants that are effective, the eye health of patients, who have an eye disease or are at risk, to develop one whose cause lies in oxidative stress, too receive, strengthen, improve or promote.

According to one another aspect comprises a dietary or dietary supplement composition according to the present invention amounts of certain Antioxidants that, when taken daily, are effective in preventing complications of diabetic retinopathy, diabetic macular edema, macular degeneration (including AMD) or cataract to prevent, stabilize, reverse to do and / or treat.

In another aspect, a nutritional or dietary supplement composition according to the present invention comprises α-lipoic acid, phenolic acids and polyphenol compounds, vitamin C, vitamin E, vitamin B ₁ , vitamin B ₃ , vitamin B ₆ and chromium (III). In one embodiment, the phenolic acid and phenolic compounds include components of the red wine extract.

According to one another aspect may be a dietary or dietary supplement composition according to the present invention, the loss of Reduce visual acuity in diabetic patients.

The The present invention also provides a method for obtaining, reinforcing, Improving or sustaining one's eye health Patient who has an eye disease or is at risk is to develop one that is selected from the group consisting of diabetic retinopathy, diabetic macular edema, Macular degeneration (including AMD) and cataract. The Method involves the administration of a diet or diet Supplement composition to said patient, which comprises effective amounts of certain antioxidants in order to Strengthen and improve eye health of said patient or to favor.

According to one In another aspect, the use of this invention includes the supplement the diet of a human or animal oral, intraperitoneal, intravenous, subcutaneous, transcutaneous and / or intramuscular routes of administration of said antioxidants.

According to one In another aspect, the present invention also provides a method for the preparation of a dietary or dietary supplement composition ready. The method involves combining certain antioxidants in desired amounts in a dosage form.

Other Features and advantages of the present invention are achieved by the The following detailed description and the claims seen.

DETAILED DESCRIPTION

Generally The present invention provides a dietary or dietetic Supplement composition for administration to humans or other living things that provide the eye health of patients Strengthens, improves or promotes eye diseases suffer or are at risk of developing them.

According to one Aspect include such eye diseases diabetic eye diseases, Macular degeneration (including AMD), cataract and combinations one of them.

According to one In another aspect, the administration of the composition according to the present invention in the loss of vision in patients with diabetic eye complications or ophthalmia prevent, stabilize, undo and / or to treat.

In another aspect, a nutritional or dietary supplement composition of the present invention comprises α-lipoic acid, phenolic acids and polyphenol compounds (sometimes collectively referred to herein as "phenols" or "phenolic compounds"), vitamin C, vitamin E, vitamin B ₁ , vitamin B ₃ , Vitamin B ₆ and chromium. In one embodiment, the phenolic acids and polyphenol compounds comprise components of the red wine extract.

According to one another aspect may be a dietary or dietary supplement composition according to the present invention additionally a carotenoid antioxidant.

In another aspect, a nutritional or dietary supplement composition according to the present invention comprises the ingredients disclosed in Table 1, each of which is present in the stated amount. Table 1 ingredient daily dose (mg) α-lipoic acid 100-500 Antioxidant phenolic compounds 100-500 vitamin C 50-300 Vitamin E 5-50 thiamine 0.5-3 nicotinamide 5-50 pyridoxine 1-5 Chromium (III) 0.05-0.2

In one aspect, each of the ingredients listed in Table 1 may be replaced with one of its derivatives that are therapeutically or nutritionally equivalent to that ingredient. A therapeutically or nutritionally equivalent compound to an ingredient is also sometimes referred to herein as a "pharmaceutically equivalent" compound and refers to a compound which can produce the same therapeutic or nutritional effect on a subject as the subject ingredient "Pharmaceutically equivalent". However, it should be apparent to those skilled in the art that a pharmaceutically equivalent compound can be added in a composition in a different amount to produce the same efficacy as the subject ingredients. For example, α-lipoic acid, phenolic acids and polyphenol compounds, vitamin C, vitamin E, thiamine, nicotinamide and vitamin B _{6 can be} replaced with one of their pharmaceutically acceptable salts or esters in therapeutically or nutritionally equivalent amounts. It should be understood that as used herein, a pharmaceutical equivalent to an ingredient may be a derivative thereof.

however can be a pharmaceutical equivalent to an ingredient have a substantially different chemical structure, but essentially an equivalent therapeutic or nutritional Provide an effect compared to the ingredient in question. In one embodiment, a pharmaceutical equivalent to an ingredient a derivative thereof, which is the same therapeutic or nutritional effect like that Ingredient provides.

According to one another aspect, or consists essentially of a food or dietary supplement composition according to the present invention from the ingredients, which are disclosed in Table 1, wherein the active ingredients are each present in the amounts specified therein; and at least a pharmaceutically acceptable excipient.

According to one Another aspect comprises a composition according to the Table 1 further comprises one or more antioxidants and / or a or several other essential nutrients or minerals.

According to one Another aspect comprises a composition according to the additionally present a carotenoid or flavonoid, with the exception of phenolic acids and polyphenol compounds, which can be found in red wine extracts.

According to one Another aspect is the amount of such a carotenoid or flavonoid in a daily dosage of a composition according to the present invention in the range of 10 to 200 mg. alternative such amount is in the range of 20-150 mg or 20-80 mg or 50-100 mg or 50-80 mg or 50-70 mg or 10-50 mg or 10-40 mg or 10-30 mg. If a therapeutically or nutritionally equivalent Derivative of a carotenoid or flavonoid in a daily Dose according to a composition of the present Invention is used, the amount of such an equivalent in an area that is nutritional or can produce a therapeutic effect equivalent to an amount of a carotenoid or flavonoids in any of the ranges disclosed above.

According to one Another aspect may be when an ingredient in different isomeric May be present, this in a composition of the present Invention in any isomeric form or as a mixture of isomers be included (provided that the isomeric form of the composition added, the intended therapeutic or nutritional Has effect).

Alpha-lipoic acid

Alpha-Lipoic Acid ("ALA") provides exceptional antioxidant protection because, in addition to its own antioxidant activity, it is able to regenerate other oxidants in the body. "ALA is a low molecular weight substance that is found in both animals and humans ALA can be considered as a "metabolic antioxidant" because it is closely linked to cell metabolism and redox status. First, ALA is an essential cofactor in mitochondrial α-keto acid dehydrogenase complexes; thus it is essential for normal oxidative metabolism. Second, the reduction of ALA to dihydrolipoic acid ("DHLA"), which involves both NADH and NADPH, can modulate NADH / NAD ⁺ and NADPH / NADP ⁺ ratios, thus affecting many aspects of cell metabolism. Packer et al., Free Rad. Biol. Med., Vol. 22, 359 (1997) , ALA and its reduced form DHLA meet all criteria to make ALA "an ideal antioxidant". It has been called "a universal antioxidant". VE Kagan et al., Biochem. Pharmacol., Vol. 44, 1637 (1992) ,

Amphiphilic character

ALA shows its antioxidant activity in both fat and water soluble media. Furthermore, the antioxidant effect extends to both the oxidized form and the reduced form (DHLA). Exogenously supplied ALA is immediately absorbed from the diet, transported, taken up by the cells and rapidly converted to DHLA in different tissues. The resulting DHLA is also exported from the cells and can provide antioxidant protection of extracellular compartments and nearby cells; thus protection is provided for both intracellular and extracellular environments. L. Packer et al. Free Rad. Biol. Med., Vol. 19, 227 (1995) , Unlike many other antioxidants, DHLA can act as a "universal free radical quencher" that scavenges peroxyl radicals in both the cytosol and hydrophobic membrane domains. VE Kagan, Biochem. Pharmacol., Vol. 44, 1637 (1992) ,

Radical quenching activity

ALA traps hydroxyl radicals, hypochlorous acid, NO, ONOO-, H ₂ O ₂ and oxygen in the singlet state. DHLA is even an even more effective antioxidant; it also removes superoxide radicals and peroxyl radicals, which are actively formed in many metabolic processes and during the peroxidation of lipids. Packer et al., Free Rad. Biol. Med., Vol. 22, 359 (1997) ,

Metallchelatisierungsaktivität

Antioxidant activity is obtained when the electron density is transferred from the metal to the chelating ligand, so that the electrons can not be transferred to oxygen. ALA / DHLA show antioxidant activity through chelation of transition metals such. As iron, copper, cadmium, which may otherwise cause damage by free radicals in biological systems by catalyzing the decomposition of hydroperoxides, resulting in highly toxic hydroxyl radicals. GP Biewenga et al., Gene. Pharma., Vol. 29, 315 (1997) ,

Ability to interact with other antioxidants

DHLA seems to be able to regenerate other antioxidants. It is a strong reducing agent that oxidizes antioxidants such. As ascorbate, glutathione or coenzyme Q can regenerate, all of which can contribute to the regeneration of vitamin E from its radically oxidized form as well as to reduce thioredoxin. Therefore, ALA and DHLA occupy a central position in the antioxidant network. Packer, L., et al., Nutrition, Vol. 17, 888 (2001). ,

In one aspect, the amount of α-lipoic acid in a daily dose of a composition according to the present invention is in the range of about 100 to about 500 mg. Alternatively, such amount may range from about 100 to about 400 mg, or from about 100 to about 300 mg, or from about 100 to about 200 mg, or from about 150 to about 500 mg, or from about 150 to about 400 mg or from about 150 to about 300 mg, or from about 150 to about 200 mg, or from about 200 to about 500 mg, or from about 200 to about 400 mg, or from about 200 to 300 mg. When a therapeutically or nutritionally equivalent derivative of the α-lipoic acid is used in a daily dosage form according to a composition of the present invention, the amount of such an equivalent is in a range capable of producing a nutritional or therapeutic effect equivalent to an amount of α-lipoic acid in one corresponds to the areas disclosed above.

VITAMIN C

Vitamin C or ascorbic acid is a well-known, water-soluble antioxidant. It provides antioxidant protection in vivo primarily as a peroxyl and oxygen radical remover in the aqueous phase. RA Jacob and BJ Burri, Am. J. Clin. Nutr., Vol. 63, 985S (1996) , Its effectiveness is expressed through a variety of mechanisms. In principle, it works directly by intercepting ROS. Furthermore, although ascorbic acid can not intercept lipophilic radicals within the lipid compartment itself, tocopherol acts as a synergist for reducing lipid peroxyl radicals within the lipid compartment by reacting with tocoperoxyl radicals and regenerating tocopherol. E. Niki, Am. J Clin. Nutr., Vol 54, 11195, (1991) , Humans depend on external vitamin C sources to meet their vitamin C needs. Vitamin C in the form of ascorbate is found in the aqueous humor of human eyes. A high concentration of ascorbate in the aqueous humor of the eyes is maintained by active transport of ascorbate from the bloodstream to the posterior chambers of the eye. Maximum ascorbate concentration in the aqueous humor occurs at an ascorbate level in the blood plasma in the range of about 0.3 to 0.5 milligrams / deciliter (mg / dl).

The US recommended daily amount (RDA) for vitamin C in the form of ascorbic acid is 60 mg. Very large daily doses of vitamin C were over many years with no or minimal adverse effects ingested. It can receive daily income from 1000 mg or more vitamin C without known adverse effects respectively.

ascorbic acid is the preferred source of vitamin C in a composition of the present invention, although other sources such. B. sodium ascorbate alternatively can be used.

According to one Aspect is the amount of vitamin C (L-ascorbate, ascorbic acid) in a daily dose of a composition according to the present invention in the range of 50-300 mg. alternative such amount is in the range of 100-300 mg or 100-200 or 50-200 mg or 50-150 or 50-120 mg. If a therapeutically or nutritionally equivalent Derivative of ascorbic acid in a daily dose a composition according to the present invention is used is the amount of such an equivalent in an area that is nutritional or can produce therapeutic effects that amount to Ascorbic acid in one of the areas disclosed above corresponds.

VITAMIN E

vitamin E or α-tocopherol is also a well-known antioxidant. Vitamin E can work synergistically with Vitamin C to vital Protect cell functions from normal oxidants. vitamin E is a relatively non-toxic, fat-soluble vitamin. vitamin E can be easily oxidized, reducing its effectiveness significantly reduced during storage before ingestion, and this degradation should be used in the formulation of a diet or dietetic composition of the present invention become. Once ingested, vitamin E enters the body stored and can become a total body reserve of vitamin E contribute for up to a year.

Vitamin E is the main chain-breaking, lipid-soluble antioxidant in membranes. It traps free radicals, especially hydroxyl radicals and oxygen in the singlet state. BS Winkler et al., Molecular Vision, Vol. 5, 32 (1999) , It works through at least two different mechanisms: by directly trapping reactive oxygen molecules ("ROS") and by upregulating antioxidant enzymes such as glutathione peroxidase ("GPX"), superoxide dismutase ("SOD"), catalase ("CAT") and glutathione reductase ( "GR"). Vertuani et al., Current Pharm. Des., Vol. 10, 1677 (2004) , The increased oxidative stress and impaired antioxidant defense associated with hyperglycemia are also related to the oxidative damage of LDL and the increased lipid peroxide concentrations in the blood. The peroxidation of lipids is an initial process within the oxidative change of LDL induced by ROS and nitrogen molecules. The oxidative alteration of LDL appears to be a key event in the induction and / or progression of atherosclerosis. According to oxidation theory, the formation of oxidized LDL ("oxLDL") in the subendothelial space plays a causal role and antioxidants are therefore potential anti-atherogenic compounds. "OxLDL has many pro-atherogenic effects." It can stimulate the expression of endothelial adhesion molecules. has a chemotactic effect and inhibits the migration of macrophages outside the subendothelial space, thus increasing the number of leukocytes and pro-inflammatory factors involved in atherogenesis. R. Stocker, Trends Biochem., Vol. 24, 219 (1999) , In addition to the eight different forms of vitamin E, α-tocopherol is selectively retained in the body and released by the liver as an integral part of VLDL, the precursor of LDL. It is the most common and effective remover of peroxyl radicals present within LDL. α-tocopherol works by inhibiting radical chain propagation within the lipid domains, resulting in stable lipid molecules. The ability of α-tocopherol to inhibit LDL oxidation in vitro has been irrefutably proven. This observation has suggested that vitamin E may reduce the incidence of atheosclerotic lesions by preventing initial oxidative events. A. Muteanu et al., J. Cell Mol. Med., Vol. 8, 59 (2004) ,

The RDA of vitamin E in the form of DL-α-tocopheryl acetate is 30 IU. At levels as high as 800 mg, no adverse effects of DL-α-tocopheryl acetate were observed, with 1 mg of DL-α-tocopheryl acetate being equivalent to 1 IU of DL-α-tocopheryl acetate. Please refer US Patent 6,660,297 , DL-α-tocopheryl acetate is a suitable source of vitamin E in a composition according to the present invention, although other sources of vitamin E, such as e.g. As trimethyltocopheryl acetate and / or vitamin E succinate, can be used as an alternative.

α-tocopherol, that in a composition according to the present May be included in the form of α-tocopheryl nicotinate, α-tocopheryl phosphate, α-tocopheryl succinate, α-tocopheryl acetate, including an isomer thereof or a racemic one Mixture of it, be included. According to one embodiment contains a composition according to the present invention D-α-Tocopherylsuccinat. According to one Another embodiment includes a composition according to the present invention DL-α-tocopheryl acetate.

According to one another aspect is the amount of vitamin E (α-tocopheryl) in a daily dose of a composition according to the present invention in the range of 5-50 mg. alternative such amount is in the range of 5 to 40 mg, or 5 to 20 mg or 5-15 mg or 7-40 mg or 70-20 mg or 10-50 mg or 10-40 or 10-30 mg or 10-20 mg or 15-50 mg or 20-50 mg or 20-40 mg or 20-30 mg. If a therapeutic or nutritionally equivalent Derivative of α-tocopherol in a daily dose a composition according to the present invention is used is the amount of such an equivalent in an area that is nutritional or can produce a therapeutic effect that is an amount of α-tocopherol in one of the areas disclosed above.

THIAMINE (VITAMIN B ₁ )

There are indications that vitamin B ₁ (thiamine and benfotiamine, a lipophilic derivative of thiamine monophosphate) is able to prevent the development of microvascular complications in diabetes. By examining the effect of these drugs in diabetic rats, it was found that these animals had abnormally low plasma concentrations of vitamin B ₁ , possibly related to its increased urinary excretion and decreased thiamine reabsorption in renal tubules. Clinical diabetes is also associated with low vitamin B ₁ deficiency. Two studies found that 18% and 76% of the diabetic subjects studied had a plasma concentration of thiamine that was less than the normal minimum range. N. Saito et al., J. Nutr. Sci. Vitaminol., Vol. 33, 421 (1987) ; E. Havivi et al., Int. J. Nutr. Res., Vol. 61, 328 (1991) , In addition, recent studies have shown that thiamine and benfotiamine effectively reduce AGE production in human endothelial cell cultures ( F. Pomero et al., Acta Diabetol., Vol. 38, 135 (2001). ) and AGE accumulation in the retina of diabetic rats ( N. Karachalias et al., Ann. NY Acad. Sci., Vol. 1043, 777 (2005) ).

Therefore, thiamine plays an important role in the metabolism of glucose and the daily requirement for this vitamin is linked to the energy requirement, especially that which is covered by carbohydrates. It has been found that 0.33 mg of thiamine per 4400 kJ energy requirement is needed. The Nutrition and Nutrition Committee of the National Research Consortium therefore recommends that thiamine intake be 0.5 mg per 4400 kJ and assumes that this maintains a satisfactory vitamin / carbohydrate balance. Since older people use thiamine less effectively, it was also recommended that their supplemental intake be 1 mg per day regardless of their dietary intake. RE Davis and GC Icke, Adv. Clin. Chem., Vol. 23, 93 (1983 ).

There are no unfavorable side effects with thiamine uptake in RDA levels or even levels several times above RDA. The RDA for vitamin B ₁ is 1.4 mg in most countries.

Vitamin B _{1 contained} in a composition according to the present invention may be in the form of thiamine hydrochloride, thiamine monophosphate hydrochloride dihydrate, thiamine mononitrate or benfotiamine monophosphate.

In another aspect, the amount of thiamine in a daily dose of a composition according to the present invention is in a range of 0.5-3 mg. Alternatively, such an amount may be in the range of 0.5-2.5 mg or 0.5-2 mg or 0.5-1.5 mg or 0.7-3 mg or 0.7-2 mg or 1.3 mg or 1-2.5 mg or 1-2 mg or 1-1.5 mg. When a therapeutically or nutritionally equivalent derivative of thiamine is used in a daily dose of a composition according to the present invention, the amount of such an equivalent is in a range capable of producing a nutritional or therapeutic effect equivalent to an amount of thiamine in any of the above corresponds to disclosed areas. Thiamine is in the form of vitamin B ₁ . Other suitable therapeutic or nutritional equivalent derivatives of thiamine include e.g. Thiamine mononitrate, thiamine hydrochloride, thiamine dichloride, thiamine monophosphate, thiamine diphosphate, thiamine triphosphate and thiamine disulfide.

nicotinamide

Nicotinamide (also known as niacinamide), a form of vitamin B ₃ , is a water-soluble vitamin. The term "Vitamin B ₃ " refers to nicotinic acid (or niacin), which has identical vitamin action, but has very different pharmacological effects Nicotinamide is involved in a variety of biological processes, including energy production, through its major metabolites NAD ⁺ and NADP ⁺ Synthesis of fatty acids, cholesterol and steroids, signal transduction and maintenance of genome integrity Nicotinic acid is used in pharmacological doses as an antihyperlipidemic substance. C. Bourgeois, Modern Nutrition in Health and Disease, 10th Ed, Lippincott Williams & Wikins (2005) ,

The mechanism of action of niacinamide is dual: it is an essential part of NAD, so by increasing the NAD supply, it avoids NAD reduction, which typically occurs in diabetes, and acts as poly (ADP-ribose) polymerase-1 ("PARP-1") inhibitor: In diabetes, oxidative stress plays a key role in the pathogenesis of vascular complications and as an early step of such injury is considered the development of endothelial dysfunction.Hydrocycemia directly promotes endothelial dysfunction, which is a process of overproduction triggers peroxynitrite, which damages the DNA and activates PARP-1 PARP-1 is a nuclear enzyme that is activated by oxidation-induced single strand breakage of the DNA and transfers ADP ribose residues from NAD ⁺ to core proteins. Activation in diabetes is well established and contributes to diabetic endothelial dysfunction. F. Garcia-Soriano et al., Nat. Med., Vol. 7, 108 (2001) ; P. Pacher et al., Diabetes, Vol. 51, 514 (2002) , PARP-1 was involved in DNA repair, in the control of genome integrity, in apoptosis and NF-κB regulation. S. Shall et al., Mutat. Res., Vol. 460, 1 (2000) ; Kameoka et al., J. Biochem., Vol. 346, 641 (2000). ; Z. Herceg et al., Mutat. Res., Vol. 477, 97 (2001) , Furthermore, the antioxidant effect of niacinamide was demonstrated in animal models in which the content of oxidative biomarkers was reduced by niacinamide administration. MJ Stevens et al., J. Pharmacol. Exp. Ther., Vol. 320, 458 (2006) ; A. Kretowski et al., Horm. Metab. Res., Vol. 28, 35 (1996) ,

The Risk assessment for high doses of niacinamide has been done carefully checked. Short and long-term studies have shown that niacinamide has low toxicity. None carcinogenic effect could be achieved with long-term feeding of Niacinamide can be detected in rats (1% in drinking water). It gives no indication of teratogenic effects. There are some clinical ones Reports of adverse effects in humans, the higher Doses of niacinamide taken for a longer time especially with regard to the immediately reverse increase the serum content of liver enzymes. It is believed that niacinamide in doses of up to a maximum of 3 g per day partial PRP inhibition at People can achieve and its safety profile seemingly good is. F. Pociot, IDIG Workshop, Copenhagen, Denmark, 4-5 December 1992, Diabetologia 1993.

The RDA for niacin is 2-12 mg for Children and 14-16 mg for adults.

In one aspect, the amount of nicotinamide in a daily dose of a composition according to the present invention is in a range of 5-50 mg. Alternatively, such amount is in the range of 5-40 mg or 5-20 mg or 5-15 mg or 7-40 mg or 7-20 mg or 10-50 mg or 10-40 mg or 10-30 mg or 10 -20 mg or 15-50 mg or 20-50 mg or 20-40 mg or 20-30 mg. When a therapeutically or nutritionally equivalent derivative of nicotinamide is used in a daily dose of a composition according to the present invention, the amount of such equivalents is in a range capable of producing a nutritional and therapeutic effect equivalent to an amount of nicotinamide in any of the ranges disclosed above. Nicotinamide is a form of vitamin B ₃ . Other suitable therapeutically or nutritionally equivalent derivatives of nicotinamide include e.g. Nicotinamide ascorbate, nicotinic acid (or niacin) and inositol hexanicotinate.

PYRIDOXIN (VITAMIN B ₆ )

The vitamin B ₆ family consists of three members: pyridoxamine ("PM"), pyridoxine ("PN"), pyridoxal ("PL"). It is known from both in vitro and in vivo studies that PM is a potent inhibitor of AGE formation by Amadori adducts ( RG Khalifah et al., Biochem. Biophys. Res. Commun., Vol. 257, 251 (1999) ) and capable of limiting the formation of proteins that are chemically altered by carbonyls and by lipids. TO Metz et al., Arch. Biochem. Biophys., Vol. 419, 41 (2003) , For these reasons, there has been a renewed interest in the possibility of using this B ₆ vitamin as a promising pharmacological substance for the treatment of complications in diabetes. In fact, PM has a unique mechanism of action different from PN, and PN can not be converted to PM. However, PN was added to dietary supplements because a lack of PN was reported in diabetic animals as well as subjects. M. Okada et al., Diabetes Obes. Metab., Vol. 1, 221 (1999) ; JM Ellis et al., Biochem. Biophys. Res. Comm., Vol. 179, 615 (1991) ,

The US RDA varies depending on age and sex 1.3 and 2 mg.

According to one Aspect is the amount of pyridoxine in a daily Dose of a composition according to the present invention Invention in a range of 1-5 mg. Alternatively lies such an amount in a range of 1-4 mg or 1-3 mg or 1-2 mg or 1.5-4 mg or 1.5-3 mg or 1.5-2 mg or 1.7-3 mg or 1.7-2.5 mg or 1.7-2 mg. If a therapeutically or nutritionally equivalent Derivative of pyridoxine in a daily dose in one Composition according to the present invention is used is the amount of such an equivalent in an area that is nutritional or can produce therapeutic effects that amount to Pyridoxine in one of the ranges disclosed above. Other suitable therapeutic or nutritionally equivalent Derivatives of pyridoxine include, for. Pyridoxine hydrochloride, pyrodoxal, Pyridoxal 5'-phosphate, pyridoxine 5'-phosphate, pyridoxamine, pyridoxminel 5'-phosphate and 4-pyridoxic acid.

PHENOL COMPOUNDS

Phenol compounds ("phenols") are widely used in the plant kingdom, forming a group of important natural antioxidants that can be divided into many classes of compounds, ranging from phenolic acids, colored anthocyanins, simple flavonoids to complex flavonoids an aromatic ring bearing one or more hydroxyl groups Grape and grape products (juice and wine) have a high content of phenols, which can be divided into two groups: (1) phenolic acids and related compounds and (2) flavonoids Provinols ^™ , a red wine extract in dry powder form (available from SEPPIC SA, Paris, France), shows the following compounds on a weight basis: proantocyanidin B1 (1.4%), proanthocyanidin B1 (1.4%), proanthocyanidin B2 (0.87%), proanthocyanidin B3 (0.31%), proanthocyanidin B4 (0.92%), catechin (1.51%), epicatechin (1.76%), proanthocyanidin B2-3-Og allat (0.54%), epicatechin 3-O-gallate 0.1%), chlorogenic acid (0.54%), p-coumaric acid (0.18%), bile acid (0.08%), resveratrol (0, 17%), polymeric condensed tannins (17.1%) and other phenolic compounds (12.8%). It has been reported that the antioxidant effect of the phenols from grape products of known antioxidants, such as. As vitamin C, vitamin E and β-carotene, surmounted. In addition to their antioxidant activity, grape phenols also inhibit enzymes that catalyze the release of histamine, which is involved in inflammatory and allergic cascades. Red wine phenols inhibit the oxidation of low-density lipoprotein ("LDL") and inhibit platelet aggregation, thereby preventing vascular diseases such as cardiovascular disease Phenols also protect vitamins from premature oxidation and make vitamins available for their major functions Procyanidines also inhibit the activation of hyaluronidase, a proteoglycan-cleaving enzyme that attacks different tissues during inflammation. J. Shi et al., "Polyphenolics in Grape Seeds - Biochemistry and Functionality", J. Med. Food, Vol. 6, No. 4, 291 (2003) , Since many diseases of the posterior segment of the eye are caused by inflammation, grape phenols or wine extracts are an important dietary supplement for maintaining, strengthening, improving or promoting ocular health.

According to one Aspect comprises a composition according to the present invention a red wine extract in a daily Dose of about 100 to about 500 mg. Alternatively, there is one Dose in the range of about 100 to about 400 mg or about 100 to about 300 mg or from 100 to 200 mg or from about 150 to about 500 mg or from 150 to about 400 mg or from 150 to about 30 mg or from about 150 to about 200 mg, or from about 200 to about 500 mg or from about 200 to about 400 mg, or from about 200 to about 300 mg. When therapeutic or nutritionally equivalent Phenols in a daily dosage of a composition be used according to the present invention, is the amount of such phenols in a range that is nutritional or therapeutic effect, that of an amount of the red wine extract in a range disclosed above.

Phenolic compounds, that were extracted from other natural sources, can also be used as long as they are in a composition introduced in amounts according to the present invention which are pharmaceutically equivalent to the amount of Red wine extract shown here are.

Chromium (III)

Chromium (III) is a mineral that people need in trace amounts, although its mechanism of action in the body and the amount needed for optimal health are not well defined. Chromium (III) is biologically active and occurs in foods. Some studies have shown that chromium enhances the effects of insulin, a hormone important for the metabolism and storage of carbohydrates, fat and protein in the body. W. Mertz, Physiol. Rev., Vol. 49, 163 (1969) ; W. Mertz, J. Nutr., Vol. 123, 626 (1993) ; W. Mertz, Nutr. Rev., Vol. 56, 174 (1998) ; D. Porter, Jr. et al., Ellengerg &Rifkin's Diabetes Mellitus, A. Baron (Editor), 6th Ed., McGraw-Hill (2003) , It seems that chromium is also directly involved in carbohydrate, fat and protein metabolism. It can be read in published research studies that chromium deficiency can affect the body's ability to use glucose to meet its energy needs and increase insulin requirements. Chromium dietary supplements may therefore be helpful to control Type 2 diabetes or the glucose and insulin response in individuals at risk of developing the disease, as well as complications, including ocular neovascularization (eg, DR and AMD) resulting therefrom result.

The Food and Nutrition Committee ("FNB") of the Institute of Medicine has not specified a tolerable upper level of chromium intake RDA for chromium is 11 μg / day for children 1 to 3 years of age, 15 μg / day for children for adults aged 4 to 8 years and 25 to 30 μg / day A study of 10 women taking 400 μg / day of chromium (III) picolinate showed little evidence of increased oxidative damage to DNA, as shown by Antibodies to oxidized DNA base was detected. I. Kato et al., Eur. J. Epidemiol., Vol. 14, no. 6, 621 (1998) ,

According to one Aspect may be a daily dose of a composition according to the present invention comprise about 50 to about 500 μg of chromium (III). Alternatively, a daily dose of a composition of the present invention comprise about 100 to about 300 μg or about 100 to about 200 μg, or about 100 to about 150 μg or about 50 to about 150 μg, or about 50 to about 200 μg. Chromium (III), that in a composition of the present invention is included, z. As chromium (III) acetate, chromium (III) chloride, chromium (III) chloride hexahydrate, Chromium (III) chloride hydrate, chromium (III) nitrate monohydrate, chromium (III) phosphate hydrate, chromium (III) sulphate, Chromium (III) picolinate, chromium (III) nicotinate or chromium (III) histidinate available.

According to one Aspect comprises a composition according to the present invention a range of different antioxidants, which is the reduction of oxidative stress on an ocular tissue to provide ready, which is endangered, damaged to become or as a result of diabetes complications or even a natural aging process to one develop significant disease. Some of the antioxidants The present composition may act synergistically different physiological targets act to increased To provide benefits to the patient.

According to one another aspect comprises a composition of the present invention an additional material that has a health or dietary benefits.

According to one Another aspect reduces such additional material an unfavorable condition of a diabetic patient. In an embodiment is such an unfavorable Disease a diabetic eye complication. In another Embodiment involves such a diabetic eye complication a retinal complication of diabetes. According to one another embodiment comprises such a diabetic Ocular complication diabetic retinopathy, diabetic macular edema or both.

Further Ingredients that are believed to be used for maintaining, strengthening, improving or promoting the eye health can be beneficial; especially in diabetic patients, if desired, alike to a dietary or dietary Composition according to the present invention are given. Such ingredients include, for. B., but are not limited to this, β-carotene, lutein, Zeaxanthin, lycopene, astaxanthin, essential fatty acids (such as omega-3 or omega-6), nutritionally relevant Minerals and / or metals and combinations thereof as disclosed herein is.

According to one Another aspect is such an additional material in a composition according to the present invention in an amount ranging from about 100% to about 300% of the US recommended daily amount ("RDA") available or alternatively from about 100% to about 200% of the RDA for the age group and the sex of the patient.

According to one another aspect includes the essential mineral selenium. In a Embodiment is selenium in a composition according to the present invention in the form of a pharmaceutically acceptable Connection available. According to certain embodiments is the amount of selenium in a composition in the daily Dose present, from about 0.05 mg to 0.2 mg, or from about 0.05 mg to about 0.1 mg (measured as selenium).

A Composition according to the present invention can be soluble in the form of tablets, film-coated tablets, capsules Films, gels, syrups, solutions, dispersions, emulsions, Plasters and the like are present. Depending on the type Other forms are also possible when administered. In one embodiment, a composition according to the present invention as oral administration for a patient formulated.

According to one Embodiment may be a daily dose of Composition according to the present invention, wherein each ingredient is in a range, the aforementioned was, once, twice, three times, four times or more per Be administered day. Preferably, a daily Dose of a composition according to the present invention Invention provided in the form of a tablet twice a day taken, for a total of two tablets a day, or in the form of two tablets taken twice a day be, for a total of four tablets a day. Compared to take the daily dose once a day a twice daily dose with half of the daily dosage in one or more tablets per Dose improved absorption and improved maintenance of the Blood levels of the essential ingredients ready.

There the ingredients are subject to degradation over time contains a composition preferably an amount of ingredients, which is greater than the minimum disclosed here, to compensate for the degradation of the ingredients. For example the amount of each ingredient in a composition so provided that a minimum of the desired amount until the expiration date the composition on the seal label becomes. The degradation rate of each ingredient depends on its Origin from what happens when formulating the composition at the time the production should be considered. Therefore, can the exact formulation of a composition depends from the origin of the individual ingredients and the exact Length of product life before expiration vary. Typically, product shelf life is for Food or dietary supplements, for example 2 to 3 years.

The So formulations may be dependent on minor ones Deviations of the manufacturing specifications something within certain Tolerance ranges vary, as is common in this area. However, a composition may be the minimum amount of each Ingredient that was revealed here always contains still find food or dietary use.

In one aspect, a tablet having a composition according to the present invention for a daily dose of two tablets comprises the ingredients shown in Table 2. Table 2 ingredient Amount (mg) per tablet (for two tablets per day) α-lipoic acid granules 95% 102.6 Provinols ^TM (red wine extract) 90.0 Ascorbic acid granules 95% 63.2 dry vitamin E acetate 50% DC 19.4 Thiamine mononitrate 98% DC 1.2 niacinamide 11.0 Pyridoxine hydrochloride 98% DC 1.5 Chromium (III) 2% Min TriT 3.5 Microcrystalline cellulose 295.7 Silicon Dioxide 6.0 magnesium stearate 6.0 Aqua Polish P Green 079.06 MS 45 Total weight of each tablet 645

variations, when administering said composition to humans or other living things are foreseen but are not limited to providing time-release Tablets or tablets that have been made to be single Dosage or a multi-part dosage to be administered. additionally can be alternative to oral administration here Ways of administration be provided, for. B. but not on it limited, subcutaneous, sublingual, transcutaneous, intramuscular or other forms of administration.

The Ingredients of a dietary or dietary supplement composition according to the present invention are single is known to have certain different physiological effects to provide. However, the unique formulations were and the effect of this on eye health has not been known and could not be predicted.

According to one Aspect may be pharmaceutically acceptable, inactive Ingredients well known in the art, one Composition according to the present invention be added to the preparation of said composition in to support different forms. Inactive ingredients can z. B. include, but are not limited, excipients, carriers, diluents, Binders, lubricants, disintegrating agents and mixtures of it, such as Cellulose, gelatin, magnesium stearate, water, Vegetable oil, glycerin, beeswax and silica. The used certain carriers, diluents or Aids will depend on the means and the purpose for which the active ingredients are used.

According to one embodiment, a tablet formulation includes materials such as e.g. As diluents, binders, lubricants, disintegrating agents and mixtures thereof. Suitable diluents include various types of starch, lactose, mannitol, kaolin, calcium phosphate or sulfate, inorganic salts (e.g., sodium, calcium or magnesium chloride), powdered sugar and cellulose derivatives in powder form. Non-limiting examples of diluents are microcrystalline cellulose (eg. As Avicel ^® PH102 or PH101 available from FMC Pharmaceutical, Philadelphia, PA) and lactose. The average particle size for microcrystalline cellulose generally ranges from about 90 μm to about 200 μm. Suitable grades of lactose include anhydrous lactose (about 152 μm mean particle size), lactose monohydrate, and spray-dried lactose (eg, Fast ^Flo® lactose, about 87 μm mean particle size, available from Foremost Corp., Baraboo, Wisconsin).

If if desired, a binder may be added. suitable Binders include substances such. Cellulose (e.g., cellulose, e.g. Methylcellulose, ethylcellulose and hydroxymethylcellulose) polypropylpyrrolidone, Polyvinyl pyrrolidone, gelatin, gum arabic, polyethylene glycol, Starch, sugars (eg lactose, sucrose, fructose and glucose), natural and synthetic gums (eg Acacia, alginates and gum arabic) and waxes.

One Lubricant is typically used in tablet formulations, to prevent the tablet and punch from sticking in the punch stay. Suitable lubricants include lubricating solids such as Talc, magnesium and calcium stearate, stearic acid, light anhydrous silicic acid and hydrogenated vegetable oils. A preferred lubricant is magnesium stearate.

disintegrants can also be added to the composition, to break up the dosage form and release the compound. Suitable disintegrating agents include starch (e.g. Corn or potato starch and hydroxypropyl starch), Clay, celluloses (eg cellulose, wood cellulose, methyl or ethyl cellulose, substituted hydroxypropyl cellulose and carboxymethyl cellulose) Agar, algins (eg alginic acid), powdered natural Sponge, cation-exchanging resins, lemon pulp, bentonite, Sodium bicarbonate, calcium phosphate, calcium citrate, sodium lauryl sulfate and gum (e.g., guar gum).

Other suitable additives include materials such. B. agents for delayed release (eg paraffin), absorption accelerator (eg quaternary ammonium compounds), surface-active Substances (eg cetyl alcohol, glycerol monostearate and sodium lauryl sulfate), absorptive carriers (eg kaolin or bentonite), preservatives, Sweeteners, colorants, flavorings (eg citric acid, menthol, glycine or orange powder) and stabilizers (eg, citric acid or sodium citrate), Binders (eg, hydroxypropylmethylcellulose) and mixtures from that.

One safe and effective method for preventing, stabilizing, Undoing and / or treating complications in diabetic retinopathy, diabetic macular edema, Cataract, glaucoma, macular degeneration or ophthalmia (such as uveitis) involves providing a daily Dose for a human or another living being that 100 to 500 mg of α-lipoic acid, 100-500 mg phenols from red wine extract, 50-300 mg vitamin C, 5-50 mg vitamin E, 0.5-3 mg thiamine, 5-50 mg nicotinamide, 1-5 mg pyridoxine and 0.05-0.2 mg chromium (III).

According to one Aspect includes a safe and effective method of preventing Stabilize, undo and / or treatment complications of diabetic retinopathy, diabetic macular edema, Cataract, glaucoma, macular degeneration or ophthalmia (such as uveitis), the administration of a daily dose for a human being or another being that exists or substantially consists of 100-500 mg of α-lipoic acid, 100-500 mg phenols from red wine extract, 50-300 mg vitamin C, 5-50 mg vitamin E, 0.5-3 mg thiamine, 5-50 mg nicotinamide, 1-5 mg pyridoxine, 0.05-0.2 mg chromium (III) and one pharmaceutically acceptable excipient.

According to one Aspect are one or more ingredients said daily Dosage by one or more of its pharmaceutically acceptable Derivatives replaced to a therapeutically equivalent total to provide each ingredient.

According to one In another aspect, a formulation is obtained which is addressed to said people or living beings at a frequency of 1, 2, 4 or more times is administered per day, so the daily dosage disclosed here is reached.

One Process for producing a food or dietary Supplement composition according to the present invention which is safe and effective in preventing, Stabilize, undo and / or treat complications of diabetic retinopathy, diabetic macular edema, Cataract, glaucoma, macular degeneration or ophthalmia (such as uveitis), including deployment from 100-500 mg of α-lipoic acid, 100-500 mg phenols from red wine extract 50-300 mg vitamin C, 5-50 mg vitamin E, 0.5-3 mg thiamine, 5-50 mg nicotinamide, 1-5 mg pyridoxine and 0.05-0.2 mg chromium (III). These Ingredients, as well as any desired inactive ingredient (such as pharmaceutically acceptable carriers) and / or additional ingredients will be in the desired Combined quantities and combined mechanically z. B. by use a mixer for producing a mixture. If needed the mixture is then further mixed until substantially uniform achieved. The mixture is then molded into articles, such as. B. Tablets, film-coated tablets or capsules. Alternatively, the mixture in the form of syrup, solution, dispersion, emulsion or gel available.

In one embodiment, the mixture is pressed using a tablet press to form tablets. Optionally, a coating can be sprayed on the tablet and the tablets dried until dry. Alternatively, the mixture may be added to mineral oil to form a slurry as a soft gel capsule ingredient, the mixture may be placed in a gelatin capsule, or the mixture may be added to another dosage form known to those skilled in the art is.

EXAMPLE 1:

A composition in the form of a tablet taken orally by a person once a day comprises the ingredients in the amounts shown in Table 1. Table 1 ingredient Quantity (mg) Preferred amount (mg) α-lipoic acid 100-250 125-225 Provinols ^TM 10-250 125-225 ascorbic acid 50-200 75-150 DL-α-Tocopherylsäure 5-30 10-25 thiamine mononitrate 1-3 1-2,5 niacinamide 10-30 15-25 pyridoxine hydrochloride 1-4 1,5-3 Chromium (III) acetate 0.3-0.7 0.4-0.6

EXAMPLE 2

A composition in the form of a tablet taken orally by a person twice a day. For a total of two tablets per day, each tablet comprises the ingredients in the amounts shown in Table II. Table II ingredient Quantity (mg) Preferred amount (mg) α-lipoic acid 50-130 60-110 Provinols ^TM 50-130 60-110 ascorbic acid 30-100 35-75 DL-α-Tocopherylsäure 5-20 6-15 thiamine mononitrate 0.5-2 0.7-1.3 niacinamide 5-15 8-12 pyridoxine hydrochloride 0.5-2 1-1,5 Chromium (III) acetate 0.15-0.4 0.2-0.3

EXAMPLE 3

A composition in the form of a film-coated tablet orally taken by a person once a day comprising the ingredients in the amounts shown in Table III. Table III ingredient Quantity (mg) Preferred amount (mg) α-lipoic acid 100-250 125-225 Provinols ^TM 100-250 125-225 ascorbic acid 50-200 75-150 DL-α-Tocopherylsäure 5-30 10-25 thiamine mononitrate 1-3 1-2,5 niacinamide 10-30 15-25 pyridoxine hydrochloride 1-4 1,5-3 Chromium (III) chloride hexahydrate 0.2-0.7 0.4-0.6

EXAMPLE 4

A composition in the form of a film-coated tablet taken orally by a person twice a day. For a total of two film-coated tablets per day, each tablet comprises the ingredients in the amounts shown in Table IV. Table IV ingredient Quantity (mg) Preferred amount (mg) α-lipoic acid 50-130 60-110 Provinols ^TM 50-130 60-110 ascorbic acid 30-100 35-75 DL-α-Tocopherylsäure 5-20 6-15 thiamine mononitrate 0.5-2 0.7-1.3 niacinamide 5-15 8-12 pyridoxine hydrochloride 0.5-2 1-1,5 Chromium (III) chloride hexahydrate 0.1-0.4 0.2-0.3

EXAMPLE 5

A composition in the form of a capsule orally taken by a person once a day comprises the ingredients in the amounts shown in Table V. Table V ingredient Quantity (mg) Preferred amount (mg) α-lipoic acid 100-250 125-225 Provinols ^TM 100-250 125-225 ascorbic acid 50-200 75-150 DL-α-Tocopherylsäure 5-30 10-25 thiamine mononitrate 1-3 1-2,5 niacinamide 10-30 15-25 pyridoxine hydrochloride 1-4 1,5-3 Chromium (III) picolinate 0.6-1.1 0.7-0.8 β-carotene 5-25 10-15

EXAMPLE 6

A composition in the form of a tablet taken orally by a person twice a day. For a total of two tablets per day, each tablet comprises the ingredients in the amounts shown in Table VI. Table VI ingredient Quantity (mg) Preferred amount (mg) α-lipoic acid 50-125 25-60 red wine extract 50-125 25-60 ascorbic acid 25-100 12-50 DL-α-Tocopherylsäure 2-15 5-12 thiamine hydrochloride 0.5-1.5 0.5-1.2 niacinamide 5-15 7-12 pyridoxine hydrochloride 0.5-2 0.5-2.5 Chromium (III) picolinate 0.3-0.5 0.4-0.7 lutein 1-10 2-7

EXAMPLE 7

A composition in the form of a tablet taken orally by a person twice a day. For a total of two tablets per day, each tablet comprises the ingredients in the amounts shown in Table VII. Table VII ingredient Quantity (mg) α-lipoic acid 50-125 red wine extract 50-125 ascorbic acid 25-100 DL-α-Tocopherylsäure 2-15 thiamine hydrochloride 0.5-1.5 niacinamide 5-15 pyridoxine hydrochloride 0.5-2 Chromium (III) picolinate 0.3-0.5 zeaxanthin 1-10

According to one another aspect includes any of the compositions of the examples 1-7 a pharmaceutically acceptable carrier.

According to one Another aspect is a composition according to the present invention essentially from the ingredients, the in one of Tables I-VII, a pharmaceutical compatible carrier and a pharmaceutical compatible diluent.

According to one Another aspect is a composition according to the The present invention consists essentially of the ingredients in Amounts listed in Table 1 or 2 and one pharmaceutically acceptable excipient.

According to one Another aspect is a composition according to the The present invention consists essentially of ingredients in the Amounts listed in Table 1 or 2, a pharmaceutically acceptable carrier and a pharmaceutically acceptable diluent.

According to one Another aspect is a composition according to the The present invention consists essentially of the ingredients in the Amounts given in Table 1 or 2; at least one material selected from the group consisting of β-carotene, Lutein, zeaxanthin, lycopene, astaxanthin, flavonoid, resveratrol, Phenolic compounds (such as oligomeric proanthocyanidins) except of red wine extract, anthocyanosides and essential fatty acids (such as omega-3 or omega-6); and a pharmaceutical excipient.

According to one Another aspect is a composition according to the present invention essentially from the ingredients, in the amounts given in Table 1 or 2; at least one Material selected from the group consisting of β-carotene, Lutein, zeaxanthin (including mesozeaxanthin), lycopene, Astaxanthin, flavonoids, resveratrol, phenolic compounds (such as. B. oligomeric proanthocyanidins) with the exception of red wine extract, Anthocyanosides and essential fatty acids (such as omega-3 or omega-6); an essential mineral or metal except of chromium (III); and a pharmaceutically acceptable Carrier.

According to one another aspect is that said essential mineral or metal is selected from the group consisting of selenium in pharmaceutically acceptable Amount (such as less than about 10 micrograms per daily dose) and pharmaceutically acceptable salts thereof.

According to one Another aspect is a composition of the present invention essentially from the ingredients in the amounts shown in table 1 and 2 are given; selected at least one material from the group consisting of β-carotene, lutein, zeaxantine, Lycopene, astaxanthin, flavonoids, resveratrol, phenolic compounds (such as oligomeric proanthocyanidins) with the exception of red wine extract, Anthocyanosides and essential fatty acids (such as omega-3 and omega-6); an essential mineral or metal, except of chromium (III); a pharmaceutically acceptable carrier; and a pharmaceutical diluent.

While certain embodiments of the present invention As previously described, those skilled in the art will recognize that many equivalents Changes, substitutions and variations are made can, without departing from the spirit and scope of the invention as defined in the appended claims.

QUOTES INCLUDE IN THE DESCRIPTION

This list The documents listed by the applicant have been automated generated and is solely for better information recorded by the reader. The list is not part of the German Patent or utility model application. The DPMA takes over no liability for any errors or omissions.

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Claims (8)

A food or dietary composition comprising, based on a daily dose: a) α-lipoic acid in an amount of about 100 to about 500 mg or a pharmaceutical equivalent from that; b) antioxidant phenol compounds in an amount of about 100 to about 500 mg or a pharmaceutical equivalent from that; c) Vitamin C in an amount of about 50 to about 300 mg or a pharmaceutical equivalent thereof; d) Vitamin E in an amount of about 5 to about 50 mg or a pharmaceutical equivalent from that; e) thiamine in an amount of about 0.5 to about 3 mg or a pharmaceutical equivalent thereof; f) Nicotinamide in an amount of about 5 to about 50 mg or a pharmaceutical equivalent from that; g) pyridoxine in an amount of about 1 to about 5 mg or a pharmaceutical equivalent thereof; and H) Chromium (III) in an amount of about 0.05 to about 0.2 mg or a pharmaceutical equivalent thereof. The composition according to claim 1, wherein α-lipoic acid in an amount of about 100-250 mg is present, the antioxidant phenol compound in an amount of about 100-250 mg are present, vitamin C is present in an amount of about 50-200 mg, vitamin E is present in an amount of about 5-30 mg, thiamine is present in an amount of about 1-3 mg, nicotinamide present in an amount of about 10-30 mg, pyridoxine present in an amount of about 1-4 mg; and chromium (III) in an amount of about 0.1-0.15 mg. The composition according to claim 1, wherein α-lipoic acid in an amount of about 125-225 mg is present, the antioxidant phenolic compounds a red wine extract and in an amount of about 125-225 mg are present, vitamin C in an amount of about 75-150 mg is present, vitamin E in an amount of about 10-25 mg is present, thiamine in an amount of about 1-2.5 mg is present, nicotinamide in an amount of about 15-25 mg is present, pyridoxine in an amount of about 1.5-3 mg is present and chromium (III) in an amount of about 0.1-0.15 is available. The composition according to claim 2 additionally comprising a pharmaceutically acceptable carrier, an essential mineral or metal except chromium (III) and at least one material selected from the group consisting from β-carotene, lutein, zeaxanthin, mesozeaxanthin, lycopene, Astaxanthin, flavonoid, resveratrol, phenolic compounds with Exception of red wine extract, anthocyanosides and essential fatty acids. The composition according to claim 4, where the essential fatty acids omega-3 and omega-6 fatty acids include. The composition according to claim 4, the essential metal except chromium (III) selenium is. A dietary or dietary supplement, for twice daily administration to an individual, full: a) α-lipoic acid in an amount from about 25 to about 60 mg or a pharmaceutical equivalent from that; b) antioxidant phenolic compounds of red wine extract in an amount of about 25 to about 60 mg or a pharmaceutical equivalent from that; c) ascorbic acid in an amount of about 12 to about 50 mg or a pharmaceutical equivalent thereof; d) DL-α-tocopherol in an amount of about 5 to about 12 mg or a pharmaceutical equivalent thereof; e) thiamine hydrochloride in an amount of about 0.5 to about 1.2 mg or a pharmaceutical equivalent thereof; f) Niacinamide in an amount of about 7 to about 12 mg or a pharmaceutical equivalent from that; g) pyridoxine hydrochloride in an amount of about 0.5 to about 2.5 mg or a pharmaceutical equivalent thereof; H) Chromium (III) picolinate in an amount of about 0.4 to about 0.7 mg or a pharmaceutical equivalent thereof; and i) Lutein in an amount of about 2 to about 7 mg or a pharmaceutical equivalent from that. A nutritional or dietary composition, based on a daily dose, consisting, or consisting essentially of: a) α-lipoic acid in an amount of about 100 to about 500 mg or a pharmaceutical equivalent thereof; b) antioxidant phenol compounds in an amount of about 100 to about 500 mg or a pharmi equivalent of it; c) Vitamin C in an amount of about 50 to about 300 mg or a pharmaceutical equivalent thereof; d) Vitamin E in an amount of about 5 to about 50 mg or a pharmaceutical equivalent thereof; e) thiamine in an amount of about 0.5 to about 3 mg or a pharmaceutical equivalent thereof; f) nicotinamide in an amount of about 5 to about 50 mg or a pharmaceutical equivalent thereof; g) pyridoxine in an amount of about 1 to about 5 mg or a pharmaceutical equivalent thereof; h) chromium (III) in an amount of about 0.05 to about 0.2 mg or a pharmaceutical equivalent thereof; and i) at least one pharmaceutically acceptable excipient.