Carotenoid-nicotinamide-zinc compositions and methods of treatme

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...

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514356, 514419, 514763, 514762, 424641, 424643, A61K 31455

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06020351&

DESCRIPTION:

BRIEF SUMMARY
BACKGROUND OF THE INVENTION

This invention relates to new and improved compositions for and methods of treating humans and other animals to reduce DNA damage, enhance DNA repair capacity, and stimulate immune cellular function. More particularly, it relates to the administration to human (or other animal) subjects of a combination of carotenoid material, nicotinamide material, and zinc source material (all as hereinafter defined), e.g. as a drug treatment or a daily dietary supplement, and to compositions containing that combination of materials.
The term "carotenoid material" as used herein means carotenoids, such as material selected from the group consisting of alpha carotene, beta carotene, gamma carotene, lycopene and mixtures thereof. The term "nicotinamide material" as used herein means material selected from the group consisting of nicotinamide, niacin, tryptophane (an amino acid precursor to niacin synthesis) and mixtures thereof. The term "zinc source material" as used herein means an appropriate source of zinc for administration to humans and/or other animals, e.g. one or more zinc salts, such as zinc sulfate or other zinc salts like amino acids such as methionine or aspartate, dipeptides, gluconates, halides, nitrates, oxides or acetates.
In a specific aspect, the invention relates to a novel combination of naturally occurring carotenoid material, nicotinamide material and zinc source material as a combined treatment to aid patients in resisting cellular DNA damage such as oxidative damage, enhancing cellular DNA repair capacity and stimulating immune cellular function. In another specific sense, this combination of chemicals can be used as a dietary supplementation, or as a drug treatment, to prevent (or improve an individual's ability to resist) DNA damage, enhance DNA repair and stimulate immune function in diseases where these processes are central to the manifested disease state; e.g. ageing, cancer, cardiovascular disease and autoimmune disorders such as diabetes, rheumatoid arthritis and ulcerative colitis (Cross et al., Ann. Int. Med. 107:526-545, 1987; Harris, C. C., Cancer Res. 51(Suppl): 5023s-5044s, 1991; Olin, K. L. et al., Proc. Soc. Expt. Biol and Med. 203(4):461-466, 1993).
Carotenoids (Lupulescu, A., Int. J. Vit. Nutri. Res. 64(1): 3-14, 1993; Prabhala, R. H. et al., Ann. N. Y. Acad. Sci. 691:262-263, 1993; Chew, B. P. J., Dairy Sci. 76(9):2804-2811, 1993; Santamaria, L. et al., J. Nutri. Sci. Vit. Spec. No:321-326, 1992; Machlin, L. J., Crit. Rev. Food Sci. and Nutri. 35 (1-2):41-50, 1995; Murakoshi, M. et al., Cancer Res. 52:6583-6587, 1992; Okuzumi, J. et al., Oncology 49:492-497, 1992), nicotinamide
iacin (Mandrup-Poulsen, T. et al., Diabetes Metabolism Rev. 9(4):295-309, 1993; Pero, R. W. et al., Biochimie, 77:385-393, 1995; Shockett, P. J., Immunol. 151(12):6962-6976, 1993; Boulikas, T., AntiCancer Res. 12(3):885-898, 1992; Brown, R. R., Adv. Expt. Med. Biol. 294:425-435, 1991; Henkin, Y. et al., Amer. J. Med. 91(3):239-246, 1991; Jacobsen, E. L., J. Am. Col. Nutri. 12(4):412-416, 1993) and zinc (Singh, A. et al., J. Appl. Physiology 76(6):2298-2303, 1994; Walsh, C. T. et al., Environmental Health Perspectives 102(Suppl. 2):5-46, 1994; Mocchegiani, E. et al., Blood 83(3):749-757, 1994; Singh, K. P. et al., Immunopharmacol, Immunotoxicol. 14(4):813-840, 1992; Mei, W. et al., Biol. Trace Element Res. 28(1):11-19, 1991; Chandra, R. K. et al., Clin. Lab. Med. 13(2):455-461, 1993) are each individually well recognized to possess disease preventive and immune stimulatory properties, even though they have never been combined with each other as a combination therapy, where they could prevent or delay human diseases and stimulate immune function (Compendium of Nonprescription Products, Canadian Pharmaceutical Association, 1994; Canadian Drug Identification Code, June 1995; The Extra Pharmacopoeia, Martindale, 30th edition; U.S. Pharmacopoeia Dispensing Information, 15th edition, 1995). Hence, it is not obvious from the scientific literature, or from availability of commercial pr

REFERENCES:
patent: 5162369 (1992-11-01), Ashmead et al.
patent: 5294606 (1994-03-01), Hastings
patent: 5310554 (1994-05-01), Haigh
patent: 5424331 (1995-06-01), Shlyankevich
Rabinovitch et al., DNA Fragmentation is an Early Event in Cytokine-Induced Islet Beta-Cell Destruction, Chemical Abstracts, vol. 371, No. 8, Abstract No. 121:228605, 1994.
Jacobson et al., A Biomarker for the Assessment of Niacin Nutriture as a Potential Preventive Factor in Carcinogenesis, Chemical Abstracts, vol. 233, No. 1, Abstract No. 119:158939, 1993.

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