Status:
COMPLETED
Effect of Revival Soy on Weight Loss and Skin, Hair, and Nails in Premenopausal Women
Lead Sponsor:
Physicians Pharmaceuticals, Inc.
Collaborating Sponsors:
Dermatology Consulting Services, High Point NC
Conditions:
Skin Aging
Weight Loss
Eligibility:
FEMALE
25-45 years
Phase:
PHASE4
Brief 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 wome...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00352157
Start Date
July 1 2006
End Date
March 1 2007
Last Update
July 21 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dermatology Consulting Services
High Point, North Carolina, United States, 27262