Central Obesity Clinical Trial
Official title:
Soy as an Innovative Dietary Component in Abdominal Obesity Management
NCT number | NCT02375113 |
Other study ID # | CRSGP 2012 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2012 |
Est. completion date | December 2014 |
Verified date | May 2022 |
Source | The University of Texas at San Antonio |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | December 2014 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 45 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Human Nutrition Lab, UTSA | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas at San Antonio |
United States,
Umana CK, Wilmoth S, Pan M, Zhang JQ, Fogt DL, He M. Effects of Soy Supplementation on Abdominal Obesity and Metabolic Risks on Post-Menopausal Women: A Pilot Study. Austin Journal of Obesity & Metabolic Syndrome. (1): 1-6, 2017.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Body Fat (kg) | Total body fat and abdominal fat were measured by DEXA (Hologic QDR Discovery A, Bedford, MA) | Study endpoint (6 months post intervention) | |
Secondary | BMI (kg/m^2) | Body Mass Index (BMI) was calculated using the equation of weight (kg) over height (m) squared (kg/m^2) | Study endpoint (6 months post intervention) | |
Secondary | Blood Pressure (mmHg) | Subjects' resting systolic and diastolic blood pressure (SBP and DBP, mmHg) was measured with an electronic sphygmomanometer (Omron, USA). | Study endpoint (6 months post intervention) | |
Secondary | Lipid Profile and Fasting Glucose | High-density lipoprotein (HDL) (mg/L) normal range > 40 mg/dL Low-density lipoprotein (LDL) (mg/L) normal range <100 mg/dL Triglyceride (TG) (mg/L) normal range <150 mg/dl Fasting glucose (mg/dl) normal range: <100 mg/dl C-Reactive Protein (mg/dl): <3 mg/dl in healthy individuals | Study endpoint (6 months post intervention) | |
Secondary | Waist Circumference (cm) | Waist Circumference was measured midway between the iliac crest and bottom of the rib cage (cm) | Study endpoint (6 months post intervention) | |
Secondary | Insulin Resistance | Insulin sensitivity index as measured by homeostasis model assessment-insulin resistance (HOMA-IR Index): Normal range 0.5-1.4 | Study endpoint (6 months post intervention) | |
Secondary | Inflammatory Cytokines IL-6 (ng/ml) | Inflammatory cytokines IL-6 (ng/ml): 75-80 ng/ml in healthy individuals | Study endpoint (6 months post intervention) | |
Secondary | C-Reactive Protein (mg/L) | C-Reactive Protein (mg/L) <3 mg/L in healthy individuals | Study endpoint (6 months post intervention) |
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