Effect of Isoflavone Supplementation Associated With Physical Exercise in the Health Parameters of Postmenopausal Women

Study Overview
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Brief Summary
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This study evaluate if 10 weeks of mixed exercise combined with isoflavones could have greater effects on climacteric symptoms, body composition and hydratation, lipidic and inflamatory profile than exercise alone in postmenopausal women. the participants will be randomly assigned to the group: placebo and exercise or 100mg of isoflavone and exercise.

Detailed Description
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Several endocrine metabolic changes occur during the climacteric period, due to the lack of estrogen and also by the aging process and some studies show that ingestion of isoflavones by postmenopausal women may have benefits. Theoretically the isoflavone potentiate the effects obtained during exercise

Official Title
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Effect of Isoflavone Supplementation Associated With Physical Exercise on Blood Pressure, Lipic and Inflamatory Profile, Body Composition and Hydratation and Climacteric Symptoms in Postmenopausal Women

Conditions
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Bloodpressure

Intervention / Treatment
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* Other: exercise
* Other: isoflavone
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy postmenopausal woman to be able to practice exercises on treadmill and weight exercises without physical complications that prevent the execution of physical exercises have no history of cardiovascular disease, diabetes, renal pathologies or hypertension Exclusion Criteria: smokers use hormone therapy or isoflavone use drugs that interfere with lipid and antihypertensive metabolism

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group isoflavone and exercise<br>The isoflavone group received daily 100mg of isoflavones. | Other: exercise<br>* The training program consisted of aerobic and resisted combined physical exercises performed during 10 weeks, three times weekly with 45 minutes sessions: 5 minutes of warm-up on treadmill, 20 minutes of aerobic exercises and 20 minutes of resistance exercises.<br>Other: isoflavone<br>* Daily supplementation in 1 capsule per day of 100mg of isoflavones (containing 3.3% genistein, 93.5% dadzein and 3.2% glycitein).<br>|
| Experimental: group placebo and exercise<br>The placebo group received 100mg containing starch of corn. | Other: exercise<br>* The training program consisted of aerobic and resisted combined physical exercises performed during 10 weeks, three times weekly with 45 minutes sessions: 5 minutes of warm-up on treadmill, 20 minutes of aerobic exercises and 20 minutes of resistance exercises.<br>Other: Placebo<br>* Daily supplementation in 1 capsule per day containing starch of corn.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure | Evaluate change in blood pressure through ambulatory 24-hour blood pressure monitoring used before the begin of intervention and after 10 weeks. | Change in blood pressure in 10 weeks intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Climateric Symptoms (Kupperman-Blatt Index) | Evaluate the intensity of climateric symptoms using the Kupperman-Blatt Index questionnaire. Consists of 11 questions in which the symptoms are given numerical values according to their intensity . | before and after 10 weeks | 
| Climateric Symptoms (Cervantes Scale) | Evaluate the intensity of climateric symptoms using the Cervantes Scale questionnaire. Composed of 31 questions distributed in four domains and 6 possibilities of answer. | before the begin the intervention and after 10 weeks | 
| Climateric Symptoms (Menopause Rating Scale) | Evaluate the intensity of climateric symptoms using the Menopause Rating Scale questionnaire. Composed of eleven questions, with five possible answers, Symptoms divided into somatovegetative, psychological and urogenital domains may be classified as absent, mild, moderate, severe and very severe. With a general score ranging from 0 to 55 points | before and after 10 weeks | 
| Lipid profile (enzymatic colorimetric method) | The concentrations in mg/dL of total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol and uric acid will be made through the enzymatic colorimetric method. The glucose will be analyzed by the enzymatic method and the glycated hemoglobin A1c by the turbidimetry method. | before and after 10 weeks | 
| Human cytokines (Flow Cytometry) | Measurement in pg/mL of the production of human cytokines (IL-8, IL-1β, IL-6, TNF ( tumor necrosis factor), IL-10 and IL-12p70) in serum samples will be performed by the flow cytometry (FACSCantoII BDTM) Human Inflammatory Cytokines Kit (BD ™ Cytometric Bead Array (CBA), BD Biosciences, San Jose, CA, USA) according to the manufacturer's instructions. | before and after 10 weeks | 
| Antioxidant capacity | The total antioxidant capacity will be evaluated in plasma and saliva using the FRAP (Ferric-Absorbing Ability of Plasma) methodology (Benzie and Strain, 1999). | before and after 10 weeks | 
| Total protein | The determination of the total salivary and plasma protein will be performed by the Bradfort method (Bradford, 1976) adapted for microplate | before and after 10 weeks | 
| Body Composition | Bioelectrical impedance (Biodynamics, model 450c, EUA) will be used to determine absolute and relative extracellular mass and body cell mass. | before and after 10 weeks | 
| Phase Angle | Phase angle in degrees (o) was calculated using the equation (Reactance/Resistance) *(180/л) using a values obtained on bioelectrical impedance (Biodynamics, model 450c, EUA) | before and after 10 weeks | 
| Oxidative stress (SOD, Catalase and TBARS activity) | The enzyme superoxide dismutase (SOD) will be dosed from the auto oxidation capacity of pyrogallol, a process dependent on the superoxide radical (Fernandes et al., 2011). . Catalase activity in saliva will be determined based on the decrease in absorbance of hydrogen peroxide (H2O2) (Aebi, 1984). Thiobarbituric acid reactive substances (TBARS) will be detected by the Yagi method (Yagi, 1998). | before and after 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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isoflavone, blood pressure, climateric symptoms, exercise