Effects of Probiotic Supplementation in Hypertensive Women on Menopause

Menopause Clinical Trial

Official title:

Effects of Probiotic Supplementation on Autonomic Nervous System Imbalance and Vascular Changes in Hypertensive Menopausal Women: RANDOMIZED CLINICAL TRIAL

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03955159
• Other study ID #: 549019
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2019
• Est. completion date: August 10, 2021

Study information

• Verified date: January 2020
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: Aline Dalmazo, Especialist
• Phone: +5551999774646
• Email: aline[@]dalmazo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: August 10, 2021
• Est. primary completion date: March 10, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Brazil	Instituto de Cardiologia do Rio Grande do Sul	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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