Effects of Probiotic Supplementation in Hypertensive Women on Menopause

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Systemic Arterial Hypertension, Menopause, Dysbiosis, Autonomic Nervous System Imbalance

Intervention / Treatment
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* Dietary Supplement: Probiotic supplementation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Probiotic supplementation<br>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<br>* 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.<br>|
| Placebo Comparator: Placebo comparator<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |