Effects of Probiotic Supplementation in Hypertensive Women on Menopause

Not Applicable

• Conditions: Menopause; Systemic Arterial Hypertension; Dysbiosis; Autonomic Nervous System Imbalance

• Registration Number: NCT03955159
• Lead Sponsor: Instituto de Cardiologia do Rio Grande do Sul

Brief Summary

In postmenopausal women, cardiovascular risk is increased and the mechanisms involving imbalance of the Autonomic Nervous System should be extensively investigated. Recent data suggest a link with intestinal microbiota dysbiosis and probiotic supplementation could be a useful strategy for treating women with increased cardiovascular risk.

Detailed Description

After randomization, subjects will be included in their intervention group for a period of three months with initial and final evaluations.

The study will evaluate the effects and possible benefits of probiotic supplementation on the functioning of the Autonomic Nervous System and vascular changes in hypertension in menopausal women.

The intervention groups will be as follows:

1. - Menopausal women with hypertension + Probiotic supplementation

2. - Menopausal women with hypertension + Placebo supplementation

Study Timeline

• Study First Submitted: 2019-04-15
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-17
• Study Start: 2019-06-10
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-23
• Last Update Posted: 2020-01-27
• Primary Completion: 2021-03-10
• Study Completion: 2021-08-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 86

Inclusion Criteria

• Hypertensive
• At least 1 year of menopause
• Sedentary

Exclusion Criteria

• Smoker
• Use of psychiatric medications
• Cardiovascular events
• Recent surgeries
• Diabetic
• Use of beta blockers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Autonomic Nervous System	3 months	The data will be collected through the system of acquisition of pressure waves in a continuous and non-invasive way by the Finometer® system, through a cuffing installed in the middle finger, taking this signal to an analog-to-digital signal converter. The pulse pressure signal will be acquired at 1000 Hz, continuously and non-invasively, supine (10 minutes) in a quiet environment, with controlled temperature (± 23 ° C) and illumination.; The collected data will be saved in the software BeatsScope® and LabChart®, from which will be extracted the syistograms for analysis.; The autonomic nervous system will be assessed at baseline and after 3 months of intervention.

Trial Locations

Locations (1)

Instituto de Cardiologia do Rio Grande do Sul; 🇧🇷 Porto Alegre, RS, Brazil