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Effects of Probiotic Supplementation in Hypertensive Women on Menopause

Primary Purpose

Systemic Arterial Hypertension, Menopause, Dysbiosis

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Probiotic supplementation
Sponsored by
Instituto de Cardiologia do Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Arterial Hypertension

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto de Cardiologia do Rio Grande do SulRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental: Probiotic supplementation

Placebo comparator

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 15, 2019
Last Updated
January 23, 2020
Sponsor
Instituto de Cardiologia do Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT03955159
Brief Title
Effects of Probiotic Supplementation in Hypertensive Women on Menopause
Official Title
Effects of Probiotic Supplementation on Autonomic Nervous System Imbalance and Vascular Changes in Hypertensive Menopausal Women: RANDOMIZED CLINICAL TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 10, 2019 (Actual)
Primary Completion Date
March 10, 2021 (Anticipated)
Study Completion Date
August 10, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Cardiologia do Rio Grande do Sul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: - Menopausal women with hypertension + Probiotic supplementation - Menopausal women with hypertension + Placebo supplementation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Arterial Hypertension, Menopause, Dysbiosis, Autonomic Nervous System Imbalance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Probiotic supplementation
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo comparator
Arm Type
Placebo Comparator
Arm Description
The placebo that will be used in the present study is maltodextrin, which is a food supplement based on carbohydrate powder.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic supplementation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Autonomic Nervous System
Description
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.
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aline Dalmazo, Especialist
Phone
+5551999774646
Email
aline@dalmazo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Claudia Irigoyen, PhD
Phone
+555132303600
Email
hipirigoyen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Claudia Irigoyen, PhD
Organizational Affiliation
Instituto de Cardiologia - Fundação Universitária de Cardiologia
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto de Cardiologia do Rio Grande do Sul
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90040371
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liliana Fortini Cavalheiro Boll, Msc
Phone
051 32303600
Ext
4070
Email
liliana.lic@cardiologia.org.br

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Probiotic Supplementation in Hypertensive Women on Menopause

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