Autonomic Nervous System Imbalance, Dysbiosis, Menopause, Systemic Arterial Hypertension
Conditions
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
Interventions
DIETARY_SUPPLEMENTProbiotic 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.
Sponsors
Instituto de Cardiologia do Rio Grande do Sul
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Autonomic Nervous System | 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. |
Countries
Brazil
Contacts
Primary ContactAline Dalmazo, Especialist
Backup ContactMaria Claudia Irigoyen, PhD
Outcome results
None listed