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

NCT ID: NCT03008785

Last Updated: 2019-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-12-31

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

Conditions

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Bloodpressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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group isoflavone and exercise

The isoflavone group received daily 100mg of isoflavones.

Group Type EXPERIMENTAL

exercise

Intervention Type 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.

isoflavone

Intervention Type OTHER

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

group placebo and exercise

The placebo group received 100mg containing starch of corn.

Group Type EXPERIMENTAL

exercise

Intervention Type 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.

Placebo

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

isoflavone

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

Intervention Type OTHER

Placebo

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

Intervention Type OTHER

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of Uberlandia

OTHER

Sponsor Role lead

Responsible Party

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Juliene Gonçalves Costa

Guilherme Morais Puga PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guilherme Puga, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Uberlandia

Locations

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Guilherme Morais Puga

Uberlândia, Minas Gerais, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 25441251 (View on PubMed)

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.

Reference Type RESULT
PMID: 24378766 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30176281 (View on PubMed)

Other Identifiers

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CAAE: 40622414.9.0000.5152

Identifier Type: -

Identifier Source: org_study_id

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