Effects of Probiotic Supplementation in Hypertensive Women on Menopause

Not Applicable

• Conditions: Menopause; Systemic Arterial Hypertension; Dysbiosis; Autonomic Nervous System Imbalance
• Interventions: Dietary Supplement: Probiotic supplementation

• 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

Arm && Interventions

Group	Intervention	Description
Experimental: Probiotic supplementation	Probiotic supplementation	The probiotic is composed of the combination of Lactobacillus acidophilus and Bifidobacterium lactis, at the concentration of 109 CFU. This product presents no known hazards associated with its use. On the contrary, the use of this supplement is associated with a rebalancing of the intestinal microbiota with potential secondary benefits to the reconstitution of the intestinal symbiosis. Patients will receive 1 sachet of 1 gram per day and will be advised to dilute in 100 mL in water at room temperature for administration.
Placebo comparator	Probiotic supplementation	The placebo that will be used in the present study is maltodextrin, which is a food supplement based on carbohydrate powder.

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