Effect of Revival Soy on Weight Loss and Skin, Hair, and Nails in Premenopausal Women
|Skin Aging Weight Loss||Behavioral: Revival Soy Dietary Supplement||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Effect of Revival Soy on Weight Loss and Appearance of Skin, Hair, and Nails in High BMI Premenopausal Women|
- Investigator assessed appearance of skin (roughness, wrinkling, dyspigmentation, and redness) at baseline and after 3 and 6 months
- Investigator assessed appearance of hair (roughness, dullness, lack of manageability, and scalp flaking) at baseline and after 3 and 6 months
- Investigator assessed appearance of finger nails (roughness, ridging, flaking, and splitting) at baseline and after 3 and 6 months.
- Body weight at monthly intervals
- Body mass index (BMI) at the baseline and study completion
- Subject-perceived changes in appearance of skin, hair, and finger nails at baseline and after 3 and 6 months
|Study Start Date:||July 2006|
|Study Completion Date:||March 2007|
The researchers hypothesize that supplementation of Revival® Soy products to overweight premenopausal women as part of a soy-based meal replacement diet plan will:
- Improve the health and appearance of the skin by normalizing skin pigmentation and reducing wrinkles,
- Improve the health and appearance of hair by enhancing sheen and ease of combing, and
- Improve the health and appearance of nails by enhancing shine, flexibility, and strength.
- Stimulate a loss in weight and a reduction in the Body Mass Index (BMI),
For this study, obese (BMI = 30-40 kg/m2) premenopausal women (25-45 years of age) with mild to moderate photoaging (n=40) will receive either a Revival® soy shake (20 grams soy protein with 160 mg total isoflavones; n=20) or a placebo shake (20 grams of milk protein with 0 mg isoflavones; n=20) daily for 6 months. The subjects will be asked to come into the office for a total of seven visits, at baseline and at monthly intervals for 6 months. At baseline, month 3, and month 6, the subjects will be asked to complete a questionnaire in order to provide self-reported improvements related to hair, skin, and nail health. Following completion of the questionnaire, the investigator and the dermatology clinic staff will examine the subjects to assess the health and appearance of their skin, hair, and nails at baseline, month 3, and month 6.
After acceptance into the study, a registered dietitian will instruct the study subjects in the use of a low-energy (1,200 - 1,500 kcal/day) diet that incorporates 2 soy-based daily meal replacements (shakes, ~500 kcal), a minimum of 5 daily servings of fruits and vegetables (~300 kcal), and one entrée (~400 - 500 kcal). Subjects will be required to keep a dietary food intake record of all food and supplement use during the trial. Anthropometric data (height, body weight, waist circumference and hip circumference) will be collected at baseline and at monthly intervals.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00352157
|United States, North Carolina|
|Dermatology Consulting Services|
|High Point, North Carolina, United States, 27262|
|Principal Investigator:||Zoe D Draelos, M.D.||Dermatology Consulting Services, High Point NC|