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| Name | Class |
|---|---|
| Dermatology Consulting Services, High Point NC | OTHER |
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.
The researchers hypothesize that supplementation of Revival® Soy products to overweight premenopausal women as part of a soy-based meal replacement diet plan will:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revival Soy Dietary Supplement | Behavioral |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zoe D Draelos, M.D. | Dermatology Consulting Services, High Point NC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Consulting Services | High Point | North Carolina | 27262 | United States |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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