Healthy Clinical Trial
Official title:
A 12-Week, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health
Therefore, the present study is designed to contribute to the body of literature by investigating the effect of 12-weeks of lutein supplementation on multiple parameters of skin health and appearance in healthy women.
This is a randomized, double-blind, placebo-controlled, parallel twelve-week study of the performance of an oral test product to evaluate the effects of twelve weeks of lutein supplementation on skin health and appearance in healthy women. A seven-day washout period will precede the evaluation period. The subjects in each cohort will use consume one softgel of their assigned test product (treatment or placebo) daily in the morning with breakfast for 12 weeks. Changes in skin condition and appearance as well as blood chemistry will be assessed using results from expert visual grading, instrumental assessments, skin and blood assays and subjective questionnaire responses. Subjects will be recruited during the winter season to account for seasonal variations of skin parameters. Evaluation points will occur pre-application (Baseline; Week 0) and after 42 and 84 days of use (D42, D84; Week 6, Week 12). Data will be collected on the following outcomes: 1. Skin Hydration 2. Skin texture/smoothness 2. Reduction of facial fine lines and wrinkles 3. Skin elasticity and firmness 4. Sagging skin, dry skin, skin tone, appearance from expert clinical grading and subjective questionnaire responses. 6. Skin hydration 7. Skin collagen 8. Skin lipid content. 9. Skin Carotenoids ;
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