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

July 20, 2009 updated by: Physicians Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Dermatology Consulting Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Females
  • Age: 25-45 years.
  • BMI between 30 - 40 kg/m2.
  • Motivated to lose weight.
  • Subjects must be in general good health as determined from a medical history.
  • Subjects must have mild to moderate photoaging.
  • Subjects must use a shampoo from the approved list without change for the entire duration of the study.
  • Must not be consuming soy supplements or other soy products currently.
  • Must not be pregnant (negative pregnancy test at screening) and agree not to become pregnant during the course of the study.
  • Subjects must read and sign the informed consent form after the nature of the study has been fully explained.

Exclusion Criteria:

  • Subjects with known allergies or sensitivities to ingredients contained in the dietary supplement.
  • Subjects who are required to spend excessive time in the sun (i.e. lifeguards, other outdoor workers).
  • Subjects who are currently participating or have participated within the last 4 weeks in any other clinical study (i.e., dermal patch, use tests, investigational drug or devices, etc.).
  • Subjects viewed by the investigator as not being able to complete the study.
  • Subjects who are unwilling to leave all of their current skin care products unchanged for the 6 months of the study.
  • Subjects who are unwilling to leave all of their current nail care products unchanged for the 6 months of the study.
  • Subjects who are unwilling to leave all of their current oral medications unchanged for the 6 months of the study.
  • Subjects who have experienced large variations in body weight during the previous 3 months
  • Subjects currently using other weight loss medications or supplements.
  • Subjects who had surgical intervention for the treatment of obesity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Physicians Pharmaceuticals, Inc.

Collaborators

Dermatology Consulting Services, High Point NC

Investigators

  • Principal Investigator: Zoe D Draelos, M.D., Dermatology Consulting Services, High Point NC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

July 13, 2006

First Submitted That Met QC Criteria

July 13, 2006

First Posted (Estimate)

July 14, 2006

Study Record Updates

Last Update Posted (Estimate)

July 21, 2009

Last Update Submitted That Met QC Criteria

July 20, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCS-61-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Weight Loss

Clinical Trials on Revival Soy Dietary Supplement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe