N/A
N=12
Soy as an Innovative Dietary Component in Abdominal Obesity Management Amongst Peri- and Early Menopausal Women
Central Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02375113 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Body Fat (kg) — 40.96; 40.12; 2.94; 4.26 kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- soy supplementation (Dietary_supplement)
- Age
- Adult · 45+ yrs
- Sex
- Female
- Sponsor
- The University of Texas at San Antonio
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Fat (kg) |
40.96; 40.12; 2.94; 4.26 | — |
| SECONDARY BMI (kg/m^2) |
33.45; 33.64 | — |
| SECONDARY Blood Pressure (mmHg) |
125.41; 129.99; 73.06; 74.61 | — |
| SECONDARY Lipid Profile and Fasting Glucose |
171.38; 175.16; 53.69; 47.66; 98.98; 106.9 | — |
| SECONDARY Waist Circumference (cm) |
105.59; 107.24 | — |
| SECONDARY Insulin Resistance |
1.62; 1.62 | — |
| SECONDARY Inflammatory Cytokines IL-6 (ng/ml) |
0.1; 0.04 | — |
| SECONDARY C-Reactive Protein (mg/L) |
3.11; 3.08 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02375113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.