A Phase 2, Double-Blind, Randomized, Placebo-Controlled Trial of a Novel Nutritional Supplement Product to Promote Healthy Skin

October 2011 | Volume 10 | Issue 10 | Original Article | 1106 | Copyright © 2011

Steven H. Dayan MD,a,b John P. Arkins BS,c Vinny Sharma BS,d Elaine Paterson PhD,e David Barnes PhDf

aChicago Center for Facial Plastic Surgery bClinical Assistant Professor of Otolaryngology at University of Illinois at Chicago cResearch Coordinator, DeNova Research dLake Erie College of Osteopathic Medicine eManger of Clinical Research, Standard Process fDirector of Research, StandardProcess

Abstract

Background: Despite an abundance of nutritional supplements, very few well-controlled trials have assessed their beneficial effect on the skin, such as hydration, antioxidant levels, texture or appearance. The objective of the following placebo-controlled, double-blind study was to determine the effects of the Skin Health Experimental Product (SHEP) on skin health.
Methods: The study enrolled healthy men and women aged 30 years or older. Subjects were randomized to receive a twice-daily regimen of SHEP or placebo. The effects SHEP had on overall skin appearance and health were assessed by measuring improvements in: (1) skin hydration using a closed-aperture transepidermal water-loss moisture meter and a vapometer; (2) skin texture using silicon profilometry; (3) skin carotenoid concentration using Raman spectrometry; and (4) reported self-image assessments using the Global Aesthetic Improvement Scale (GAIS).
Results: SHEP-treated subjects demonstrated a significant reduction in fine lines compared to the placebo-treated group. Raman spectroscopy showed that SHEP increased carotenoids at some measurement sites. Based on the GAIS, SHEP-treated subjects were three times more likely to perceive an improvement in their appearance compared to placebo-treated subjects (P>0.049).
Conclusion: The orally-administered SHEP nutritional supplement improves skin texture, carotenoid levels in specific areas of the hand, and improves patients' perception of skin health.

J Drugs Dermatol. 2011;10(9):1106-1114.

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INTRODUCTION

While the saying “we are what we eat” is a familiar one, to what degree is it true and to what extent does it actually affect our appearance? The impact diet has on health and wellness is gaining increased popular interest and research focus. Many sectors of society consume an imbalanced diet with insufficient quantities of a variety of nutrients, leading to risk for a wide range of diseases.1 Current evidence suggests that diets high in antioxidants, low in saturated and trans fats, and rich in omega-3 fatty acids are associated with increased lifespan and decreased incidence of cardiovascular disease.2 Unfortunately, transforming this information into a vitamin or nutritional supplement has not been a simple task. The results of clinical trials that enrolled individuals already suffering from illness have demonstrated the beneficial effects of omega-3 fatty acids,3,4 calcium,5 vitamin D,6 and vitamin E;7-9 however, it has been suggested (although not proven) that certain nutrients are associated with increased mortality rates, such as high-dose vitamin E and A supplementation.10,11

Fueled by a $26.9 billion dollar industry with a relatively low barrier to entry, there has been a steady increase in the number of available nutritional products geared to promote increased vitality. Similarly, there is growing interest in potential benefits that nutritional supplementation may confer on the health and appearance of the skin, but few well-designed studies support these claims. Much of our current understanding of nutrition,

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