Bloodpressure
Conditions
Keywords
isoflavone, blood pressure, climateric symptoms, exercise
Brief summary
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
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
Interventions
OTHERexercise
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.
OTHERisoflavone
Daily supplementation in 1 capsule per day of 100mg of isoflavones (containing 3.3% genistein, 93.5% dadzein and 3.2% glycitein).
OTHERPlacebo
Daily supplementation in 1 capsule per day containing starch of corn.
Sponsors
Federal University of Uberlandia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood pressure | Change in blood pressure in 10 weeks intervention | Evaluate change in blood pressure through ambulatory 24-hour blood pressure monitoring used before the begin of intervention and after 10 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Climateric Symptoms (Cervantes Scale) | before the begin the intervention and after 10 weeks | Evaluate the intensity of climateric symptoms using the Cervantes Scale questionnaire. Composed of 31 questions distributed in four domains and 6 possibilities of answer. |
| Climateric Symptoms (Menopause Rating Scale) | before and after 10 weeks | 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 |
| Lipid profile (enzymatic colorimetric method) | before and after 10 weeks | 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. |
| Human cytokines (Flow Cytometry) | before and after 10 weeks | 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. |
| Climateric Symptoms (Kupperman-Blatt Index) | before and after 10 weeks | 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 . |
| Total protein | before and after 10 weeks | The determination of the total salivary and plasma protein will be performed by the Bradfort method (Bradford, 1976) adapted for microplate |
| Body Composition | before and after 10 weeks | Bioelectrical impedance (Biodynamics, model 450c, EUA) will be used to determine absolute and relative extracellular mass and body cell mass. |
| Phase Angle | before and after 10 weeks | 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) |
| Oxidative stress (SOD, Catalase and TBARS activity) | before and after 10 weeks | 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). |
| Antioxidant capacity | before and after 10 weeks | The total antioxidant capacity will be evaluated in plasma and saliva using the FRAP (Ferric-Absorbing Ability of Plasma) methodology (Benzie and Strain, 1999). |
Countries
Brazil
Outcome results
None listed