Soy as an Innovative Dietary Component in Abdominal Obesity Management Amongst Peri- and Early Menopausal Women

Completed · Not applicable · Has a placebo group

Conditions studied: Central Obesity

In brief

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.

Key facts

Study ID

NCT02375113

Run by

The University of Texas at San Antonio

People needed

12

Starts

2012-09-01

Expected to finish

2014-12-01

Last updated by the study team

2024-05-10

Who can join

Age: 45 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Human Nutrition Lab, UTSA — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.