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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Soy supplementation: Isoflavones 160 mg/day + 25 gram soy protein / day |
|
| Control | Placebo Comparator | Placebo capsules + 25 gram whey protein / day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meizi He, PhD | University of Texas at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Nutrition Lab, UTSA | San Antonio | Texas | 78249 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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De-identified individual participant data for all primary and secondary outcome measures will be made available.
Data will be available after 12 months of study completion.
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.
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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 .
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
12 subjects were randomly assigned into either Intervention or Control. 1 subject in the Control discontinued for undisclosed reasons; another dropped out due to ingestion discomfort; 1 Intervention subject discontinued for undisclosed reason. At study endpoint, 5 subjects remained in the Intervention, with 1 being excluded due to poor adherence.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Body Fat (kg) | Total body fat and abdominal fat were measured by DEXA (Hologic QDR Discovery A, Bedford, MA) | 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. | Posted | Mean | Standard Error | kg | Study endpoint (6 months post intervention) |
|
The data and adverse effect was monitored from the start of the 6-month period to the end.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Discomfort of ingesting daily protein shake | Gastrointestinal disorders | Other | Systematic Assessment |
The small sample size led to insufficient statistical power to detect small intervention effect.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Meizi He | The University of Texas at San Antonio | 2104585416 | meizi.he@utsa.edu |
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| ID | Term |
|---|---|
| D056128 | Obesity, Abdominal |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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|
| 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) |
| Discomfort of ingesting daily protein sh |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Secondary | BMI (kg/m^2) | Body Mass Index (BMI) was calculated using the equation of weight (kg) over height (m) squared (kg/m^2) | 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. | Posted | Mean | Standard Error | kg/m^2 | Study endpoint (6 months post intervention) |
|
|
|
| Secondary | Blood Pressure (mmHg) | Subjects' resting systolic and diastolic blood pressure (SBP and DBP, mmHg) was measured with an electronic sphygmomanometer (Omron, USA). | 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. | Posted | Mean | Standard Error | mm Hg | Study endpoint (6 months post intervention) |
|
|
|
| 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 | 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. | Posted | Mean | Standard Error | mg/dl | Study endpoint (6 months post intervention) |
|
|
|
| Secondary | Waist Circumference (cm) | Waist Circumference was measured midway between the iliac crest and bottom of the rib cage (cm) | 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. | Posted | Mean | Standard Error | cm | Study endpoint (6 months post intervention) |
|
|
|
| Secondary | Insulin Resistance | Insulin sensitivity index as measured by homeostasis model assessment-insulin resistance (HOMA-IR Index): Normal range 0.5-1.4 | 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. | Posted | Mean | Standard Error | HOMA-IR Index | Study endpoint (6 months post intervention) |
|
|
|
| Secondary | Inflammatory Cytokines IL-6 (ng/ml) | Inflammatory cytokines IL-6 (ng/ml): 75-80 ng/ml in healthy individuals | 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. | Posted | Mean | Standard Error | ng/ml | Study endpoint (6 months post intervention) |
|
|
|
| Secondary | C-Reactive Protein (mg/L) | C-Reactive Protein (mg/L) <3 mg/L in healthy individuals | 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. | Posted | Mean | Standard Error | mg/L | Study endpoint (6 months post intervention) |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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. | 0 | 6 | 0 | 6 | 1 | 6 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| LDL (mg/dl) |
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| TG (mg/dl) |
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| Glucose (mg/dl) |
|