Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
Study NCT ID:
NCT03955159
Status:
UNKNOWN
Last Update Posted:
2020-01-27
First Post:
2019-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Probiotic Supplementation in Hypertensive Women on Menopause
Sponsor:
Instituto de Cardiologia do Rio Grande do Sul
Organization:
Study Overview
Official Title:
Effects of Probiotic Supplementation on Autonomic Nervous System Imbalance and Vascular Changes in Hypertensive Menopausal Women: RANDOMIZED CLINICAL TRIAL
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: