A Phase 4 interventional study of Revival Soy Dietary Supplement in Skin Aging and Weight Loss, sponsored by Physicians Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to female participants aged 25 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-07-21.
Sponsored by Physicians Pharmaceuticals, Inc. · Phase 4, Interventional, and Treatment
The purpose of this study is to determine if dietary consumption of Revival Soy can improve the appearance of the skin, hair, and finger nails and support weight loss in overweight, premenopausal women.
The researchers hypothesize that supplementation of Revival® Soy products to overweight premenopausal women as part of a soy-based meal replacement diet plan will:
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.
1,224 studies on the registry are indexed under Body Weight; 132 are open to participants now.
This study's enrollment of 40 is below the median of 64 across 948 interventional studies indexed under Body Weight.
Browse Body Weight studies →This is the only study on the registry with Physicians Pharmaceuticals, Inc. as lead sponsor.
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Exclusion Criteria:
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
This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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