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

Soy as an Innovative Dietary Component in Abdominal Obesity Management

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.

Study Overview

• Status: Completed
• Conditions: Central Obesity
• Intervention / Treatment: Dietary supplement: soy supplementation

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78249
      • Human Nutrition Lab, UTSA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Soy supplementation: Isoflavones 160 mg/day + 25 gram soy protein / day	Dietary supplement: soy supplementation; Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months. Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.
Placebo Comparator: Control; Placebo capsules + 25 gram whey protein / day	Dietary supplement: soy supplementation; Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months. Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
C-Reactive Protein (mg/L)	C-Reactive Protein (mg/L) <3 mg/L in healthy individuals	Study endpoint (6 months post intervention)

Collaborators and Investigators

• Sponsor: The University of Texas at San Antonio
• Investigators: Principal Investigator: Meizi He, PhD, University of Texas at San Antonio

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: February 28, 2013
• First Submitted That Met QC Criteria: February 27, 2015
• First Posted (Estimated): March 2, 2015

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Obesity prevention; Soy supplementation
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Abdominal
• Other Study ID Numbers: CRSGP 2012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: Data will be available after 12 months of study completion.
• IPD Sharing Access Criteria: Data access requests will be reviewed by an Review Panel at the University of Texas at San Antonio. Requestors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR