Effects of Probiotic Supplementation in Hypertensive Women on Menopause

NCT ID: NCT03955159

Last Updated: 2020-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-10
• Study Completion Date: 2021-08-10

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Probiotic supplementation

Intervention Type: 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.

Placebo comparator

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

Group Type: PLACEBO_COMPARATOR

Probiotic supplementation

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Cardiologia do Rio Grande do Sul

OTHER

Sponsor Role: lead

Responsible Party

Aline Dalmazo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Claudia Irigoyen, PhD

Role: STUDY_CHAIR

Instituto de Cardiologia - Fundação Universitária de Cardiologia

Locations

Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Aline Dalmazo, Especialist

Role: CONTACT

aline@dalmazo.com

+5551999774646

Maria Claudia Irigoyen, PhD

Role: CONTACT

hipirigoyen@gmail.com

+555132303600

Facility Contacts

Liliana Fortini Cavalheiro Boll, Msc

Role: primary

liliana.lic@cardiologia.org.br

051 32303600 ext. 4070

Other Identifiers

549019

Identifier Type: -

Identifier Source: org_study_id