Skin Elasticity Clinical Trial
Official title:
Evaluation of the Effects of Eggshell Membrane in Protecting Skin From Damage Caused by Environmental Challenges and Aging
This study is intended to evaluate the efficacy of oral supplementation of an unhydrolyzed eggshell membrane ingredient (uESM) vs placebo on both objective and subjective markers of skin aging in middle-aged and senior adults using the Cutometer® MPA 580 multi-probe system along with specially designed subject questionnaires. Secondary objectives will be to assess the benefits of uESM on the health of hair and fingernails based on a subject questionnaire.
This study will be conducted according to a single-center, randomized, double-blind, placebo-controlled trial design. The study protocol will be approved by an independent institutional review board (IRB) and patients will provide their written informed consent to participate. The nutritional ingredient used in this study will be unhydrolyzed eggshell membrane (uESM) (Ovolux™ brand) (ESM Technologies LLC, Carthage, MO. USA), an unhydrolyzed, minimally processed chicken eggshell membrane powder. Up to 90 subjects will be evaluated in this placebo-controlled study at a single investigational site in the U.S. Subjects will be randomly divided into three groups of equal numbers. The first group will receive a treatment protocol consisting of enough capsules to provide a daily dose of two capsules containing one 300 mg capsule of uESM + 1 dummy capsule of psyllium husk fiber, the second group will receive enough capsules for a two capsule daily dose containing two 300 mg capsules of uESM, and a third group will receive enough capsules for a two capsule daily dose containing just psyllium husk fiber as a placebo treatment. Subjects will take the capsules with a morning meal for 12 consecutive weeks. Assessments will be performed at baseline (Day 0), at Week 6 and again at the end of the study (Week 12). After a period of 10-30 minutes at the study facility for acclimation to the study center environment, skin elasticity, firmness, and fatigue will be measured using the Cutometer® MPA 580 multi-probe system by applying a constant negative pressure. Trans-epidermal water loss (TEWL) will be evaluated with the Cutometer® MPA 580 multi-probe system utilizing a TEWL probe, and changes in skin hydration will be measured with the Cutometer® MPA 580 multi-probe system utilizing a corneometer probe. Subjects will also be given questionnaires to evaluate subjective responses to skin look and feel and to evaluate subjects' observations regarding changes in the condition and growth of hair and fingernails. ;
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