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

Not Applicable

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Intervention	soy supplementation	Soy supplementation: Isoflavones 160 mg/day + 25 gram soy protein / day
Control	soy supplementation	Placebo capsules + 25 gram whey protein / day

Primary Outcome Measures

Name	Time	Method
Body Fat (kg)	Study endpoint (6 months post intervention)	Total body fat and abdominal fat were measured by DEXA (Hologic QDR Discovery A, Bedford, MA)

Secondary Outcome Measures

Name	Time	Method
Blood Pressure (mmHg)	Study endpoint (6 months post intervention)	Subjects' resting systolic and diastolic blood pressure (SBP and DBP, mmHg) was measured with an electronic sphygmomanometer (Omron, USA).
Waist Circumference (cm)	Study endpoint (6 months post intervention)	Waist Circumference was measured midway between the iliac crest and bottom of the rib cage (cm)
C-Reactive Protein (mg/L)	Study endpoint (6 months post intervention)	C-Reactive Protein (mg/L) \<3 mg/L in healthy individuals
BMI (kg/m^2)	Study endpoint (6 months post intervention)	Body Mass Index (BMI) was calculated using the equation of weight (kg) over height (m) squared (kg/m\^2)
Lipid Profile and Fasting Glucose	Study endpoint (6 months post intervention)	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
Insulin Resistance	Study endpoint (6 months post intervention)	Insulin sensitivity index as measured by homeostasis model assessment-insulin resistance (HOMA-IR Index): Normal range 0.5-1.4
Inflammatory Cytokines IL-6 (ng/ml)	Study endpoint (6 months post intervention)	Inflammatory cytokines IL-6 (ng/ml): 75-80 ng/ml in healthy individuals