Back to resultsSoy as an Innovative Dietary Component in Abdominal Obesity Management Amongst Peri- and Early Menopausal Women
Primary Purpose
Central Obesity
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
soy supplementation
Sponsored by
About this trial
This is an interventional prevention trial for Central Obesity focused on measuring Obesity prevention, Soy supplementation
Eligibility Criteria
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.
Sites / Locations
- Human Nutrition Lab, UTSA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
Soy supplementation: Isoflavones 160 mg/day + 25 gram soy protein / day
Placebo capsules + 25 gram whey protein / day
Outcomes
Primary Outcome Measures
Change in percentage of body fat
Secondary Outcome Measures
Full Information
NCT ID
NCT02375113
First Posted
February 28, 2013
Last Updated
February 27, 2015
Sponsor
The University of Texas at San Antonio
1. Study Identification
Unique Protocol Identification Number
NCT02375113
Brief Title
Soy as an Innovative Dietary Component in Abdominal Obesity Management Amongst Peri- and Early Menopausal Women
Official Title
Soy as an Innovative Dietary Component in Abdominal Obesity Management
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas at San Antonio
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a pilot study examining the effect of dietary supplements that contain soy products. The purpose of this study to find out if soy supplementation can help to reduce the storage of a certain kind of fat on the body, visceral fat. Visceral fat is fat found deep in the abdomen; it has the potential to increase the risk of certain health problems.
Detailed Description
Obesity is a leading risk factor for many chronic diseases in the USA. Abdominal fat, specifically visceral fat is metabolically active and can be detrimental to health. Abdominal obesity is especially high in postmenopausal women (prevalence rates 50- 70%) in whom estrogen deficiency may lead to accumulation of excess visceral fat. Although estrogen replacement therapy is effective in preventing visceral fat accumulation, its adverse effects warrant a search for a safer phytochemical that exerts estrogenic properties. Soy, containing isoflavones (estrogen-like compounds), is a promising dietary component in reducing abdominal obesity in menopausal women. The favorable effects of isoflavones were already demonstrated in animal studies.The effects of soy compounds as a dietary component in preventing and reducing abdominal obesity and its associated metabolic abnormalities will be examined among menopausal Women. We will use quantitative magnetic resonance spectroscopy/imaging (qMRS/I) to determine dose and effects of soy supplementation for preventing and treating abdominal adiposity. The results from this study will shed light on the application of soy as a novel dietary approach in preventing and managing abdominal obesity among peri- and early menopausal women.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Obesity
Keywords
Obesity prevention, Soy supplementation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Soy supplementation: Isoflavones 160 mg/day + 25 gram soy protein / day
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo capsules + 25 gram whey protein / day
Intervention Type
Dietary Supplement
Intervention Name(s)
soy supplementation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in percentage of body fat
Time Frame
Baseline and study endpoint (6 months post intervention)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meizi He, PhD
Organizational Affiliation
University of Texas at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Human Nutrition Lab, UTSA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Soy as an Innovative Dietary Component in Abdominal Obesity Management Amongst Peri- and Early Menopausal Women
We'll reach out to this number within 24 hrs