Weight Loss Clinical Trial
Official title:
Effect of Revival Soy on Weight Loss and Appearance of Skin, Hair, and Nails in High BMI Premenopausal Women
Verified date | July 2009 |
Source | Physicians Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | March 2007 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 25 Years to 45 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Dermatology Consulting Services | High Point | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Physicians Pharmaceuticals, Inc. | Dermatology Consulting Services, High Point NC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Investigator assessed appearance of skin (roughness, wrinkling, dyspigmentation, and redness) at baseline and after 3 and 6 months | |||
Primary | Investigator assessed appearance of hair (roughness, dullness, lack of manageability, and scalp flaking) at baseline and after 3 and 6 months | |||
Primary | Investigator assessed appearance of finger nails (roughness, ridging, flaking, and splitting) at baseline and after 3 and 6 months. | |||
Secondary | Body weight at monthly intervals | |||
Secondary | Body mass index (BMI) at the baseline and study completion | |||
Secondary | Subject-perceived changes in appearance of skin, hair, and finger nails at baseline and after 3 and 6 months |
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