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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03008785
• Date of registration: 28/12/2016
• Prospective Registration: No
• Primary sponsor: Federal University of Uberlandia
• Public title: Effect of Isoflavone Supplementation Associated With Physical Exercise in the Health Parameters of Postmenopausal Women
• Scientific 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
• Date of first enrolment: February 2015
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03008785
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Guilherme Puga, PhD
• Affiliation: Federal University of Uberlandia

Key inclusion & exclusion 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



Age minimum: 50 Years
Age maximum: 70 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Bloodpressure

Intervention(s)

Other: Placebo

Other: exercise

Other: isoflavone

Primary Outcome(s)

Change in blood pressure [Time Frame: Change in blood pressure in 10 weeks intervention]

Secondary Outcome(s)

Climateric Symptoms (Menopause Rating Scale) [Time Frame: before and after 10 weeks]

Total protein [Time Frame: before and after 10 weeks]

Body Composition [Time Frame: before and after 10 weeks]

Climateric Symptoms (Cervantes Scale) [Time Frame: before the begin the intervention and after 10 weeks]

Antioxidant capacity [Time Frame: before and after 10 weeks]

Climateric Symptoms (Kupperman-Blatt Index) [Time Frame: before and after 10 weeks]

Oxidative stress (SOD, Catalase and TBARS activity) [Time Frame: before and after 10 weeks]

Human cytokines (Flow Cytometry) [Time Frame: before and after 10 weeks]

Lipid profile (enzymatic colorimetric method) [Time Frame: before and after 10 weeks]

Phase Angle [Time Frame: before and after 10 weeks]

Secondary ID(s)

CAAE: 40622414.9.0000.5152

Source(s) of Monetary Support

Please refer to primary and secondary sponsors