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Clinical Claims Claims for proto-col The word collagen is derived from Greek meaning 'glue forming' and is often termed connective tissue holding cells together in a scaffold type structure called matrix. Collagen is the most common protein in the body and accounts for 1/3 of total body protein, which is approximately 6% of total body weight. Each collagen molecule resembles a microscopic rope that is very strong and flexible but quite inelastic. The skin is the largest organ in the body and collagen makes up 75% of skin. Collagen content of the skin is measured skin biopsy, skin blister assessment and non-invasive laser imaging. All of these measures indicate a reduction in collagen content following menopause. Raine-Fenning, N., Bincat, M. and Muscat-Baron, Y. Skin aging and menopause: implications for treatment. Am J Clin Dermatol. 2003;4(6):371-378. M. J. Koehler, K. König, P. Elsner, R. Bückle, and M. Kaatz, "In vivo assessment of human skin aging by multiphoton laser scanning tomography," Opt. Lett.2006; 31:879-2881. The loss of collagen and elastin leads to degeneration of the skin causing wrinkles and loss of smoothness. Research has found that women lose collagen faster than men. M. J. Koehler, K. König, P. Elsner, R. Bückle, and M. Kaatz, "In vivo assessment of human skin aging by multiphoton laser scanning tomography," Opt. Lett.2006; 31:879-2881. The positive effects of the oral administration of gelatin (collagen) on skin and organs attached to the skin (including nails and hair) has been observed for some time. Moscowitz, R. Role of collagen hydrolysate in bone and joint disease. Sem Arthritis and Rheum. 2000;20(2):87-99. Morganti, P. and Randazzo, S. Nutrition and hair. J Appl Cosmerol. 1984; 2:41-49. Tyson, T. The effect of gelatin on fragile fingernails. Invest Dermatol. 1950;14:323-325. Rosenburg, S. Further studies in the use of gelatin in the treatment of brittle nails. AMA Arch Dermatol. 1957;76:330-335. Scula, J. and Holies, N. and Sucher, K. Effect of daily gelatin ingestion on human hair scalp. Nutrition Reports International. 1976;13(6):579-592. An 8 week collagen supplementation trial (3500mg, 3 times daily) has been shown to significantly improve periorbital (around the eye) wrinkles and aging. Kantor, I., Donikyan, L., Simon, R., and Wollschlaeger, B. Results of a study evaluating the use of dietary supplement formula in the management of age-related skin changes in women with moderate to severe wrinkling of the periorbital area. JANA 2002; 5(2):10-19. Epidermal thinning, declining dermal collagen content, diminished skin moisture, decreased laxity and impaired wound healing have been reported in post menopausal women. Hall, G. and Phillips, T. Estrogen and skin: the effects of estrogen, menopause, and hormone replacement therapy on the skin. J Am Acad Dermatol. 2005;53(4):555-568. Estrogen deprivation is associated with a premature aging of the dermal elastic fibers of the skin. Bolognia, J., Braverman, I., Rousseau, M and Sarrel, P. Skin changes and the menopause. Maturitas. 1989;11(4):295-304. Pruritus, bruising, dryness and thinning are seen more frequently in sun-exposed skin – this termed photoaging. Bolognia, J., Braverman, I., Rousseau, M and Sarrel, P. Skin changes and the menopause. Maturitas. 1989;11(4):295-304. Repeated ultraviolet (UV) exposure (sun) breaks down collagen and impairs the synthesis of new collagen. Fisher GJ. The Pathophysiology of Photoaging of the Skin. Cutis, 2005;75(2S):5-9. Moschella S and Hurley H. (1992) Aging and Its Effects on the Skin. Dermatology: Third Edition. Philadelphia: W.B. Saunders Company. Chung, J., Seo, J., Choi, H., Lee, M. Young, C, Rie, G, Cho, K., Kim, K., Park, K. and Eun, H. Modulation of skin collagen metabolism in aged and photoaged human skin in vivo. Am J Patrhol. 2001;158(3):931-942. Talwar, H., Griffiths, C., Fisher, G., Hamilton, T. and Voorhees, J. Reduced type I and type III procollagens in photodamaged adult human skin. J Invest Dermatol. 1995;105:285-290. Yamauchi, M., Prisayan, P., Haque, Z. an d Woodley, D. Collagen cross-linking in sun-exposed and unexposed sites of aged human skin. J Invest Dermatol. 1991;97:938-941. Cigarette smoking causes biochemical changes in our bodies that accelerate aging. Research shows that a person who smokes 10 or more cigarettes a day for a minimum of 10 years is statistically more likely to develop deeply wrinkled, leathery skin than a nonsmoker. It also has been shown that people who smoke for a number of years tend to develop an unhealthy yellowish hue to their complexion. Additionally, a study conducted in 2002 showed that facial wrinkling, while not yet visible, can be seen under a microscope in smokers as young as 20. Koh JS et al. Cigarette smoking associated with premature facial wrinkling: image analysis of facial skin replicas. International Journal of Dermatology, 2002;41(1)21-27. Demierre MF et al. Public knowledge, awareness, and perceptions of the association between skin aging and smoking. Journal of the American Academy of Dermatology, 1999;41(1):27-30. Bone turnover, the process of bone destruction and bone formation continues throughout life. Peak bone mass occurs between the age of 20-30 years following which bone loss begins at a rate of about 1% to 2% per years. This rate of bone loss accelerates during menopause and can result in a disorder termed 'osteoporosis'. Clinical studies suggest that the ingestion of collagen (10g daily) reduces pain in patients with osteoarthritis of the knee or hip. Moscowitz, R. Role of collagen hydrolysate in bone and joint disease. Seminars Arthritis and Rheum. 2000;20(2):87-99. Clinical use is associated with minimal adverse effects, mainly gastrointestinal, characterized by fullness or unpleasant taste. Moscowitz, R. Role of collagen hydrolysate in bone and joint disease. Seminars Arthritis and Rheum. 2000;20(2):87-99.