- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02375113
Soy as an Innovative Dietary Component in Abdominal Obesity Management Amongst Peri- and Early Menopausal Women
Soy as an Innovative Dietary Component in Abdominal Obesity Management
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78249
- Human Nutrition Lab, UTSA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Between the ages of 45 and 60
- experiencing irregular menses along with one or more other symptoms of menopause including: vaginal dryness, difficulty sleeping, hot flashes, mood changes, increased abdominal/belly fat, or with cessation of menstrual cycle for no more than three years
- having a BMI greater than 25
- Waist circumference greater than 88 cm
- having the ability to understand study procedures and to comply with them for the entire length of the study.
Exclusion Criteria:
- Have ever been diagnosed with cancer
- Have tumors in the reproductive system
- Allergies to soy or milk protein
- Have known metabolic disorders that may affect body weight and body composition (e.g., hypercortisolism and hypothyroidism, non-alcoholic fatty liver disease)
- Are receiving hormone replacement therapy or estrogen-like remedy
- Are taking medications (e.g., thyroid, cortisol/cortisone, ephedra, thermogenics, etc) within 30 days prior to the start of the study.
- Are emotional or uncontrolled eaters as measured by a brief screening tool Three-Factor Eating Questionnaire (TFEQ), i.e., 3 "yes" to the three emotional eating questions or 2 "yes" to the 2 uncontrolled eating questions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Soy supplementation: Isoflavones 160 mg/day + 25 gram soy protein / day
|
Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months. Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone. |
Placebo Comparator: Control
Placebo capsules + 25 gram whey protein / day
|
Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months. Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in percentage of body fat
Time Frame: Baseline and study endpoint (6 months post intervention)
|
Baseline and study endpoint (6 months post intervention)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Meizi He, PhD, University of Texas at San Antonio
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRSGP 2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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