Expired Study
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San Antonio, Texas 78249


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: 1. Between the ages of 45 and 60 2. 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 3. having a BMI greater than 25 4. Waist circumference greater than 88 cm 5. having the ability to understand study procedures and to comply with them for the entire length of the study. Exclusion Criteria: 1. Have ever been diagnosed with cancer 2. Have tumors in the reproductive system 3. Allergies to soy or milk protein 4. Have known metabolic disorders that may affect body weight and body composition (e.g., hypercortisolism and hypothyroidism, non-alcoholic fatty liver disease) 5. Are receiving hormone replacement therapy or estrogen-like remedy 6. Are taking medications (e.g., thyroid, cortisol/cortisone, ephedra, thermogenics, etc) within 30 days prior to the start of the study. 7. 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 is Available At:


Original ID:

CRSGP 2012


NCT ID:

NCT02375113


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 2/Phase 3


Genders:

Female


Minimum Age:

45 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The University of Texas at San Antonio


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

12


Enrollment Type:

Actual


Overall Contact Information

Official Name:Meizi He, PhD
Principal Investigator
University of Texas at San Antonio

Study Dates

Start Date:September 2012
Completion Date:December 2014
Completion Type:Actual
Primary Completion Date:August 2013
Primary Completion Type:Actual
Verification Date:January 2013
Last Changed Date:February 27, 2015
First Received Date:February 28, 2013

Study Outcomes

Outcome Type:Primary Outcome
Measure:Change in percentage of body fat
Time Frame:Baseline and study endpoint (6 months post intervention)
Safety Issues:True

Study Interventions

Intervention Type:Dietary Supplement
Name:soy supplementation
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 cap
Arm Name:Intervention

Study Arms

Study Arm Type:Experimental
Arm Name:Intervention
Description:Soy supplementation: Isoflavones 160 mg/day + 25 gram soy protein / day
Study Arm Type:Placebo Comparator
Arm Name:Control
Description:Placebo capsules + 25 gram whey protein / day

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:The University of Texas at San Antonio

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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