Central Obesity
Conditions
Keywords
Obesity prevention, Soy supplementation
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.
Interventions
DIETARY_SUPPLEMENTsoy 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.
Sponsors
The University of Texas at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 |
| 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) |
| 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) |
| 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 |
| C-Reactive Protein (mg/L) | Study endpoint (6 months post intervention) | C-Reactive Protein (mg/L) \<3 mg/L 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 |
Countries
United States
Participant flow
Recruitment details
This was a six-month randomized double-blind, placebo-controlled trial. Subjects, early post-menopausal women, were recruited from the local community via flyers, bulletin board advertisements and word-of-mouth referrals. Subjects were randomly assigned to either the Intervention group or the Control group .
Participants by arm
| Arm | Count |
|---|---|
| Intervention Soy supplementation: Isoflavones 160 mg/day + 25 gram soy protein / day
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. | 4 |
| Control Placebo capsules + 25 gram whey protein / day
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. | 4 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discomfort of ingesting daily protein sh | 0 | 1 |
| Overall Study | Poor adherence (<70%). | 1 | 0 |
| Overall Study | Undisclosed Reason(s). | 1 | 1 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 54.3 years STANDARD_DEVIATION 4.4 | 53.7 years STANDARD_DEVIATION 4 | 54.0 years STANDARD_DEVIATION 4.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 4 participants | 4 participants | 8 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 1 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Body Fat (kg)
Total body fat and abdominal fat were measured by DEXA (Hologic QDR Discovery A, Bedford, MA)
Time frame: Study endpoint (6 months post intervention)
Population: The GLM Univariate procedure was used to determine intervention effects. The models included outcome measures as the dependent variable, treatment condition as the fixed factor (1=control; 2=intervention), and corresponding baseline outcome measures and age were covariates.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Body Fat (kg) | Total body fat (kg) | 40.96 kg | Standard Error 0.84 |
| Intervention | Body Fat (kg) | Abdominal fat (kg) | 2.94 kg | Standard Error 0.57 |
| Control | Body Fat (kg) | Total body fat (kg) | 40.12 kg | Standard Error 0.97 |
| Control | Body Fat (kg) | Abdominal fat (kg) | 4.26 kg | Standard Error 0.49 |
Secondary
Blood Pressure (mmHg)
Subjects' resting systolic and diastolic blood pressure (SBP and DBP, mmHg) was measured with an electronic sphygmomanometer (Omron, USA).
Time frame: Study endpoint (6 months post intervention)
Population: The GLM Univariate procedure was used to determine intervention effects. The models included outcome measures as the dependent variable, treatment condition as the fixed factor (1=control; 2=intervention), and corresponding baseline outcome measures and age were covariates.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Blood Pressure (mmHg) | SBP (mm Hg) | 125.41 mm Hg | Standard Error 6.11 |
| Intervention | Blood Pressure (mmHg) | DBP (mm Hg) | 73.06 mm Hg | Standard Error 3.42 |
| Control | Blood Pressure (mmHg) | SBP (mm Hg) | 129.99 mm Hg | Standard Error 6.64 |
| Control | Blood Pressure (mmHg) | DBP (mm Hg) | 74.61 mm Hg | Standard Error 3.55 |
Secondary
BMI (kg/m^2)
Body Mass Index (BMI) was calculated using the equation of weight (kg) over height (m) squared (kg/m\^2)
Time frame: Study endpoint (6 months post intervention)
Population: The GLM Univariate procedure was used to determine intervention effects. The models included outcome measures as the dependent variable, treatment condition as the fixed factor (1=control; 2=intervention), and corresponding baseline outcome measures and age were covariates.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | BMI (kg/m^2) | 33.45 kg/m^2 | Standard Error 0.5 |
| Control | BMI (kg/m^2) | 33.64 kg/m^2 | Standard Error 0.5 |
Secondary
C-Reactive Protein (mg/L)
C-Reactive Protein (mg/L) \<3 mg/L in healthy individuals
Time frame: Study endpoint (6 months post intervention)
Population: The GLM Univariate procedure was used to determine intervention effects. The models included outcome measures as the dependent variable, treatment condition as the fixed factor (1=control; 2=intervention), and corresponding baseline outcome measures and age were covariates.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | C-Reactive Protein (mg/L) | 3.11 mg/L | Standard Error 0.04 |
| Control | C-Reactive Protein (mg/L) | 3.08 mg/L | Standard Error 0.05 |
Secondary
Inflammatory Cytokines IL-6 (ng/ml)
Inflammatory cytokines IL-6 (ng/ml): 75-80 ng/ml in healthy individuals
Time frame: Study endpoint (6 months post intervention)
Population: The GLM Univariate procedure was used to determine intervention effects. The models included outcome measures as the dependent variable, treatment condition as the fixed factor (1=control; 2=intervention), and corresponding baseline outcome measures and age were covariates.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Inflammatory Cytokines IL-6 (ng/ml) | 0.1 ng/ml | Standard Error 0.05 |
| Control | Inflammatory Cytokines IL-6 (ng/ml) | 0.04 ng/ml | Standard Error 0.06 |
Secondary
Insulin Resistance
Insulin sensitivity index as measured by homeostasis model assessment-insulin resistance (HOMA-IR Index): Normal range 0.5-1.4
Time frame: Study endpoint (6 months post intervention)
Population: The GLM Univariate procedure was used to determine intervention effects. The models included outcome measures as the dependent variable, treatment condition as the fixed factor (1=control; 2=intervention), and corresponding baseline outcome measures and age were covariates.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Insulin Resistance | 1.62 HOMA-IR Index | Standard Error 0.42 |
| Control | Insulin Resistance | 1.62 HOMA-IR Index | Standard Error 0.51 |
Secondary
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
Time frame: Study endpoint (6 months post intervention)
Population: The GLM Univariate procedure was used to determine intervention effects. The models included outcome measures as the dependent variable, treatment condition as the fixed factor (1=control; 2=intervention), and corresponding baseline outcome measures and age were covariates.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Lipid Profile and Fasting Glucose | HDL (mg/dl) | 53.69 mg/dl | Standard Error 3.13 |
| Intervention | Lipid Profile and Fasting Glucose | TG (mg/dl) | 114.05 mg/dl | Standard Error 3.09 |
| Intervention | Lipid Profile and Fasting Glucose | LDL (mg/dl) | 98.98 mg/dl | Standard Error 6.42 |
| Intervention | Lipid Profile and Fasting Glucose | Glucose (mg/dl) | 85.98 mg/dl | Standard Error 2.08 |
| Intervention | Lipid Profile and Fasting Glucose | TC (mg/dl) | 171.38 mg/dl | Standard Error 3.45 |
| Control | Lipid Profile and Fasting Glucose | Glucose (mg/dl) | 89.47 mg/dl | Standard Error 2.19 |
| Control | Lipid Profile and Fasting Glucose | TC (mg/dl) | 175.16 mg/dl | Standard Error 3.33 |
| Control | Lipid Profile and Fasting Glucose | HDL (mg/dl) | 47.66 mg/dl | Standard Error 3.04 |
| Control | Lipid Profile and Fasting Glucose | LDL (mg/dl) | 106.9 mg/dl | Standard Error 6.06 |
| Control | Lipid Profile and Fasting Glucose | TG (mg/dl) | 104.98 mg/dl | Standard Error 3.19 |
Secondary
Waist Circumference (cm)
Waist Circumference was measured midway between the iliac crest and bottom of the rib cage (cm)
Time frame: Study endpoint (6 months post intervention)
Population: The GLM Univariate procedure was used to determine intervention effects. The models included outcome measures as the dependent variable, treatment condition as the fixed factor (1=control; 2=intervention), and corresponding baseline outcome measures and age were covariates.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Waist Circumference (cm) | 105.59 cm | Standard Error 0.3 |
| Control | Waist Circumference (cm) | 107.24 cm | Standard Error 0.3 |