Effect of Revival Soy on Weight Loss & Skin, Hair, & Nails in

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00352157
Study type	Interventional
Source	Physicians Pharmaceuticals, Inc.
Contact
Status	Completed
Phase	Phase 4
Start date	July 2006
Completion date	March 2007

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Revival Soy on Weight Loss and Skin, Hair, and Nails in Premenopausal Women

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms