Clinical trial NCT03008785: Effect of Isoflavone Supplementation Associated With Physical Exercise in the Health Parameters of Postmenopausal Women
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bloodpressure
Keywords: isoflavone
blood pressure
climateric symptoms
exercise
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 32
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in blood pressure
timeFrame: Change in blood pressure in 10 weeks intervention
Secondary outcomes:
measure: Climateric Symptoms (Kupperman-Blatt Index)
timeFrame: before and after 10 weeks
measure: Climateric Symptoms (Cervantes Scale)
timeFrame: before the begin the intervention and after 10 weeks
measure: Climateric Symptoms (Menopause Rating Scale)
timeFrame: before and after 10 weeks
measure: Lipid profile (enzymatic colorimetric method)
timeFrame: before and after 10 weeks
measure: Human cytokines (Flow Cytometry)
timeFrame: before and after 10 weeks
measure: Antioxidant capacity
timeFrame: before and after 10 weeks
measure: Total protein
timeFrame: before and after 10 weeks
measure: Body Composition
timeFrame: before and after 10 weeks
measure: Phase Angle
timeFrame: before and after 10 weeks
measure: Oxidative stress (SOD, Catalase and TBARS activity)
timeFrame: before and after 10 weeks
Other outcomes:
Locations:
city: Uberlandia
country: Brazil
facility: Guilherme Morais Puga
state: Minas Gerais
Study officials:
affiliation: Federal University of Uberlandia
name: Guilherme Puga, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.