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

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

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.

Study Overview

• Status: Completed
• Conditions: Bloodpressure
• Intervention / Treatment: Other: isoflavone; Other: exercise; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Uberlandia, Minas Gerais, Brazil, 38400-678
      • Guilherme Morais Puga

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group isoflavone and exercise; The isoflavone group received daily 100mg of isoflavones.	Other: isoflavone; Daily supplementation in 1 capsule per day of 100mg of isoflavones (containing 3.3% genistein, 93.5% dadzein and 3.2% glycitein).; Other: exercise; 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.
Experimental: group placebo and exercise; The placebo group received 100mg containing starch of corn.	Other: exercise; 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.; Other: Placebo; Daily supplementation in 1 capsule per day containing starch of corn.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federal University of Uberlandia
• Investigators: Principal Investigator: Guilherme Puga, PhD, Federal University of Uberlândia

Publications and helpful links

General Publications

• Acharjee S, Zhou JR, Elajami TK, Welty FK. Effect of soy nuts and equol status on blood pressure, lipids and inflammation in postmenopausal women stratified by metabolic syndrome status. Metabolism. 2015 Feb;64(2):236-43. doi: 10.1016/j.metabol.2014.09.005. Epub 2014 Oct 5.
• Lebon J, Riesco E, Tessier D, Dionne IJ. Additive effects of isoflavones and exercise training on inflammatory cytokines and body composition in overweight and obese postmenopausal women: a randomized controlled trial. Menopause. 2014 Aug;21(8):869-75. doi: 10.1097/GME.0000000000000177.
• Barbosa CD, Costa JG, Giolo JS, Rossato LT, Nahas PC, Mariano IM, Batista JP, Puga GM, de Oliveira EP. Isoflavone supplementation plus combined aerobic and resistance exercise do not change phase angle values in postmenopausal women: A randomized placebo-controlled clinical trial. Exp Gerontol. 2019 Mar;117:31-37. doi: 10.1016/j.exger.2018.08.007. Epub 2018 Sep 1.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: December 28, 2016
• First Submitted That Met QC Criteria: December 29, 2016
• First Posted (Estimate): January 2, 2017

Study Record Updates

• Last Update Posted (Actual): February 20, 2019
• Last Update Submitted That Met QC Criteria: February 19, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: exercise; blood pressure; isoflavone; climateric symptoms
• Other Study ID Numbers: CAAE: 40622414.9.0000.5152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED