Effects of Probiotic Supplementation in Hypertensive Women on Menopause

• ClinicalTrials.gov Identifier: NCT03955159
• Recruitment Status: Unknown
• First Posted: May 17, 2019
• Last Update Posted: January 27, 2020
• Sponsor: Instituto de Cardiologia do Rio Grande do Sul
• Information provided by (Responsible Party): Aline Dalmazo, Instituto de Cardiologia do Rio Grande do Sul

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.

Condition or disease	Intervention/treatment	Phase
Systemic Arterial Hypertension; Menopause; Dysbiosis; Autonomic Nervous System Imbalance	Dietary Supplement: Probiotic supplementation	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 86 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effects of Probiotic Supplementation on Autonomic Nervous System Imbalance and Vascular Changes in Hypertensive Menopausal Women: RANDOMIZED CLINICAL TRIAL
• Actual Study Start Date: June 10, 2019
• Estimated Primary Completion Date: March 10, 2021
• Estimated Study Completion Date: August 10, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental: 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.	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.
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; 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.

Outcome Measures

Primary Outcome Measures :

1. Autonomic Nervous System [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Aline Dalmazo, Especialist; +5551999774646; aline@dalmazo.com

Contact: Maria Claudia Irigoyen, PhD; +555132303600; hipirigoyen@gmail.com

Locations

Brazil

Instituto de Cardiologia do Rio Grande do Sul; Recruiting

Porto Alegre, RS, Brazil, 90040371

Contact: Liliana Fortini Cavalheiro Boll, Msc 051 32303600 ext 4070 liliana.lic@cardiologia.org.br

Sponsors and Collaborators

Instituto de Cardiologia do Rio Grande do Sul

Investigators

• Study Chair: Maria Claudia Irigoyen, PhD; Instituto de Cardiologia - Fundação Universitária de Cardiologia

More Information

• Responsible Party: Aline Dalmazo, Principal Investigator, Instituto de Cardiologia do Rio Grande do Sul
• ClinicalTrials.gov Identifier: NCT03955159
• Other Study ID Numbers: 549019
• First Posted: May 17, 2019
• Last Update Posted: January 27, 2020
• Last Verified: January 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

Hypertension; Dysbiosis; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes