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

NCT02375113 | Completed Results

• 1 other identifier: CRSGP 2012
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Obesity

Keywords

Obesity prevention; Soy supplementation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• BMI (kg/m^2)

  Study endpoint (6 months post intervention)

• Blood Pressure (mmHg)

  Study endpoint (6 months post intervention)

• Lipid Profile and Fasting Glucose

  Study endpoint (6 months post intervention)

• Waist Circumference (cm)

  Study endpoint (6 months post intervention)

• Insulin Resistance

  Study endpoint (6 months post intervention)

Study Arms (2)

Intervention

EXPERIMENTAL

Soy supplementation: Isoflavones 160 mg/day + 25 gram soy protein / day

Dietary Supplement: soy supplementation

Control

PLACEBO COMPARATOR

Placebo capsules + 25 gram whey protein / day

Dietary Supplement: soy supplementation

Interventions

soy supplementation DIETARY_SUPPLEMENT

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.

Control; Intervention

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas at San Antonio: lead

Study Sites (1)

Human Nutrition Lab, UTSA

San Antonio, Texas, 78249, United States

Location

Related Publications (1)

• 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.

  RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Obesity, Abdominal

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The small sample size led to insufficient statistical power to detect small intervention effect.

Results Point of Contact

• Title: Dr. Meizi He
• Organization: The University of Texas at San Antonio

meizi.he@utsa.edu

2104585416

Study Officials

• Meizi He, PhD

  University of Texas at San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 28, 2013
• First Posted: March 2, 2015
• Study Start: September 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: December 1, 2014
• Last Updated: May 10, 2024
• Results First Posted: May 10, 2024

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available after 12 months of study completion.
• 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.

Locations

US (1)