Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352157
Status:
COMPLETED
Last Update Posted:
2009-07-21
First Post:
2006-07-13
Brief Title:
Effect of Revival Soy on Weight Loss and Skin Hair and Nails in Premenopausal Women
Sponsor:
Physicians Pharmaceuticals Inc
Organization:
Physicians Pharmaceuticals Inc
Study Overview
Official Title:
Effect of Revival Soy on Weight Loss and Appearance of Skin Hair and Nails in High BMI Premenopausal Women
Status:
COMPLETED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 women
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 of the skin by normalizing skin pigmentation and reducing wrinkles
Improve the health and appearance of hair by enhancing sheen and ease of combing and
Improve the health and appearance of nails by enhancing shine flexibility and strength
Stimulate a loss in weight and a reduction in the Body Mass Index BMI
For this study obese BMI 30-40 kgm2 premenopausal women 25-45 years of age with mild to moderate photoaging n40 will receive either a Revival soy shake 20 grams soy protein with 160 mg total isoflavones n20 or a placebo shake 20 grams of milk protein with 0 mg isoflavones n20 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 1200 - 1500 kcalday 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
Improve the health and appearance of the skin by normalizing skin pigmentation and reducing wrinkles
Improve the health and appearance of hair by enhancing sheen and ease of combing and
Improve the health and appearance of nails by enhancing shine flexibility and strength
Stimulate a loss in weight and a reduction in the Body Mass Index BMI
For this study obese BMI 30-40 kgm2 premenopausal women 25-45 years of age with mild to moderate photoaging n40 will receive either a Revival soy shake 20 grams soy protein with 160 mg total isoflavones n20 or a placebo shake 20 grams of milk protein with 0 mg isoflavones n20 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 1200 - 1500 kcalday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None