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 range
25 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.