RESUMEN
OBJECTIVE: The aim of the present study was to quantify the effects on skin in post-menopausal women of a novel dietary supplement (Imedeen Prime Renewal) that contained soy extract, fish protein polysaccharides, extracts from white tea, grape seed and tomato, vitamins C and E as well as zinc and chamomile extract. DESIGN: The study was a 6-month double blind, placebo controlled, randomized study on healthy post-menopausal females. SETTING: The study was performed at a commercial Contract Research Organisation (TJ Stephens & Associates Inc., TX, USA). INTERVENTIONS: Two tablets of Imedeen Prime Renewal or placebo were given twice daily for 6 months. SUBJECTS: Thirty-eight (active group) and 42 (placebo group) subjects completed the study out of 100. RESULTS: Clinical grading showed that the active group had a significantly greater improvement (P < 0.05) compared to placebo for the face after 6 months treatment for: forehead, periocular and perioral wrinkles, mottled pigmentation, laxity, sagging, under eye dark circles and overall apperance; skin on the décolletage after 2, 3 and 6 months treatment and skin on the hand after 3 and 6 months treatment. Photo evaluation showed that the active group had a significantly greater improvement (P < 0.05) on the face after 3 and 6 months for several parameters. Ultrasound measurements showed that the active group had a significantly greater improvement (P < 0.0001) for density measurements after 6 months treatment. CONCLUSION: In summary, this novel dietary supplement, Imedeen Prime Renewal, provides improved condition, structure and firmness of the skin in post-menopausal women after 6 months.