Effects of Probiotic Supplementation in Hypertensive Women on Menopause

NCT03955159 | Unknown

• 1 other identifier: 549019
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Arterial Hypertension; Menopause; Dysbiosis; Autonomic Nervous System Imbalance

Outcome Measures

Primary Outcomes (1)

• Autonomic Nervous System

  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.

  3 months

Study Arms (2)

Experimental: Probiotic supplementation

EXPERIMENTAL

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.

Dietary Supplement: Probiotic supplementation

Placebo comparator

PLACEBO COMPARATOR

The placebo that will be used in the present study is maltodextrin, which is a food supplement based on carbohydrate powder.

Dietary Supplement: Probiotic supplementation

Interventions

Probiotic supplementation DIETARY_SUPPLEMENT

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.

Experimental: Probiotic supplementation; Placebo comparator

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hypertensive
• At least 1 year of menopause
• Sedentary

You may not qualify if:

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

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead

Study Sites (1)

Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90040371, Brazil

RECRUITING

MeSH Terms

Conditions

Hypertension; Dysbiosis

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Claudia Irigoyen, PhD

  Instituto de Cardiologia - Fundação Universitária de Cardiologia

  STUDY CHAIR

Central Study Contacts

Aline Dalmazo, Especialist

CONTACT

+5551999774646; aline@dalmazo.com

Maria Claudia Irigoyen, PhD

CONTACT

+555132303600; hipirigoyen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: May 17, 2019
• Study Start: June 10, 2019
• Primary Completion: March 10, 2021
• Study Completion: August 10, 2021
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)