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

NCT03008785 | Completed

• 1 other identifier: CAAE: 40622414.9.0000.5152
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Bloodpressure

Keywords

isoflavone; blood pressure; climateric symptoms; exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Climateric Symptoms (Kupperman-Blatt Index)

  before and after 10 weeks

• Climateric Symptoms (Cervantes Scale)

  before the begin the intervention and after 10 weeks

• Climateric Symptoms (Menopause Rating Scale)

  before and after 10 weeks

• Lipid profile (enzymatic colorimetric method)

  before and after 10 weeks

• Human cytokines (Flow Cytometry)

  before and after 10 weeks

Study Arms (2)

group isoflavone and exercise

EXPERIMENTAL

The isoflavone group received daily 100mg of isoflavones.

Other: exercise; Other: isoflavone

group placebo and exercise

EXPERIMENTAL

The placebo group received 100mg containing starch of corn.

Other: exercise; Other: Placebo

Interventions

exercise OTHER

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.

group isoflavone and exercise; group placebo and exercise

isoflavone OTHER

Daily supplementation in 1 capsule per day of 100mg of isoflavones (containing 3.3% genistein, 93.5% dadzein and 3.2% glycitein).

group isoflavone and exercise

Placebo OTHER

Daily supplementation in 1 capsule per day containing starch of corn.

group placebo and exercise

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• smokers
• use hormone therapy or isoflavone
• use drugs that interfere with lipid and antihypertensive metabolism

Sponsors & Collaborators

• Federal University of Uberlandia: lead

Study Sites (1)

Guilherme Morais Puga

Uberlândia, Minas Gerais, 38400-678, Brazil

Location

Related Publications (3)

• 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.

  PMID: 25441251 BACKGROUND

• 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.

  PMID: 24378766 RESULT

• 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.

  PMID: 30176281 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise; Isoflavones

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Guilherme Puga, PhD

  Federal University of Uberlandia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guilherme Morais Puga PhD

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: January 2, 2017
• Study Start: February 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 20, 2019

Record last verified: 2019-02

Locations

BR (1)