CompletedNot Applicable

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

United States12 participantsStarted 2012-09

Plain-language 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.

Who can participate

Age range45 Years – 60 Years

SexFEMALE

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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.

What they're measuring

Body Fat (kg)

Timeframe: Study endpoint (6 months post intervention)

Trial details

NCT IDNCT02375113

SponsorThe University of Texas at San Antonio

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-08

Results submitted2019-03-27

View on ClinicalTrials.gov More Central Obesity trials