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

Not Applicable

Completed

• Conditions: Bloodpressure
• Interventions: Other: exercise; Other: isoflavone; Other: Placebo

• Registration Number: NCT03008785
• Lead Sponsor: Federal University of Uberlandia

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

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2016-07
• Study Completion: 2016-12
• Study First Submitted: 2016-12-28
• Study First Submitted QC: 2016-12-29
• Study First Posted: 2017-01-02
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-19
• Last Update Posted: 2019-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group placebo and exercise	exercise	The placebo group received 100mg containing starch of corn.
group isoflavone and exercise	exercise	The isoflavone group received daily 100mg of isoflavones.
group isoflavone and exercise	isoflavone	The isoflavone group received daily 100mg of isoflavones.
group placebo and exercise	Placebo	The placebo group received 100mg containing starch of corn.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	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 (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.
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).
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).
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 .
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.

Trial Locations

Locations (1)

Guilherme Morais Puga; 🇧🇷 Uberlandia, Minas Gerais, Brazil