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OpenTrials
Completed

NCT Number: NCT02375113

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

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.

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Key information

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Human Nutrition Lab, UTSA

San Antonio, Texas, 78249, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Body Fat (kg)

    Time frame: Study endpoint (6 months post intervention)

    Total body fat and abdominal fat were measured by DEXA (Hologic QDR Discovery A, Bedford, MA)

Secondary outcomes

  1. BMI (kg/m^2)

    Time frame: 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)

  2. Blood Pressure (mmHg)

    Time frame: 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).

  3. Lipid Profile and Fasting Glucose

    Time frame: 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

  4. Waist Circumference (cm)

    Time frame: Study endpoint (6 months post intervention)

    Waist Circumference was measured midway between the iliac crest and bottom of the rib cage (cm)

  5. Insulin Resistance

    Time frame: 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

  6. Inflammatory Cytokines IL-6 (ng/ml)

    Time frame: Study endpoint (6 months post intervention)

    Inflammatory cytokines IL-6 (ng/ml): 75-80 ng/ml in healthy individuals

  7. C-Reactive Protein (mg/L)

    Time frame: Study endpoint (6 months post intervention)

    C-Reactive Protein (mg/L) <3 mg/L in healthy individuals

Sponsors and collaborators

Lead sponsor

The University of Texas at San Antonio

Other

Registry information

Official study title

Soy as an Innovative Dietary Component in Abdominal Obesity Management

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Mar 2, 2015
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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