Clinical trial NCT02375113: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Obesity
Keywords: Obesity prevention
Soy supplementation
Lead sponsor: The University of Texas at San Antonio
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 12
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Body Fat (kg)
timeFrame: Study endpoint (6 months post intervention)
Secondary outcomes:
measure: BMI (kg/m^2)
timeFrame: Study endpoint (6 months post intervention)
measure: Blood Pressure (mmHg)
timeFrame: Study endpoint (6 months post intervention)
measure: Lipid Profile and Fasting Glucose
timeFrame: Study endpoint (6 months post intervention)
measure: Waist Circumference (cm)
timeFrame: Study endpoint (6 months post intervention)
measure: Insulin Resistance
timeFrame: Study endpoint (6 months post intervention)
measure: Inflammatory Cytokines IL-6 (ng/ml)
timeFrame: Study endpoint (6 months post intervention)
measure: C-Reactive Protein (mg/L)
timeFrame: Study endpoint (6 months post intervention)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Human Nutrition Lab, UTSA
state: Texas
Study officials:
affiliation: University of Texas at San Antonio
name: Meizi He, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.