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Effects of Probiotic Supplementation in Hypertensive Women on Menopause

NCT03955159 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2020-01-27

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

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.

Sponsors & Collaborators

  • Instituto de Cardiologia do Rio Grande do Sul

    lead OTHER

Principal Investigators

  • Maria Claudia Irigoyen, PhD · Instituto de Cardiologia - Fundação Universitária de Cardiologia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-10
Primary Completion
2021-03-10
Completion
2021-08-10

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03955159 on ClinicalTrials.gov