Trials / Unknown
UnknownNCT03955159
Effects of Probiotic Supplementation in Hypertensive Women on Menopause
Effects of Probiotic Supplementation on Autonomic Nervous System Imbalance and Vascular Changes in Hypertensive Menopausal Women: RANDOMIZED CLINICAL TRIAL
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 86 (estimated)
- Sponsor
- Instituto de Cardiologia do Rio Grande do Sul · Academic / Other
- Sex
- Female
- Age
- 45 Years – 65 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-06-10
- Primary completion
- 2021-03-10
- Completion
- 2021-08-10
- First posted
- 2019-05-17
- Last updated
- 2020-01-27
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT03955159. Inclusion in this directory is not an endorsement.