Effect of Revival Soy on Weight Loss and Skin, Hair, and Nails in Premenopausal Women (NCT00352157) | Clinical Trial Compass
CompletedPhase 4
Effect of Revival Soy on Weight Loss and Skin, Hair, and Nails in Premenopausal Women
United States40 participantsStarted 2006-07
Plain-language 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.
Who can participate
Age range25 Years – 45 Years
SexFEMALE
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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 s…
What they're measuring
1
Investigator assessed appearance of skin (roughness, wrinkling, dyspigmentation, and redness) at baseline and after 3 and 6 months
2
Investigator assessed appearance of hair (roughness, dullness, lack of manageability, and scalp flaking) at baseline and after 3 and 6 months
3
Investigator assessed appearance of finger nails (roughness, ridging, flaking, and splitting) at baseline and after 3 and 6 months.