Effects of Probiotic Supplementation on Autonomic Nervous System Imbalance and Vascular Changes in Hypertensive Menopausal Women: RANDOMIZED CLINICAL TRIAL
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Autonomic Nervous System
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Hypertensive
- •At least 1 year of menopause
- •Sedentary
排除标准
- •Use of psychiatric medications
- •Cardiovascular events
- •Recent surgeries
- •Use of beta blockers
结局指标
主要结局
Autonomic Nervous System
时间窗: 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.
次要结局
未报告次要终点
研究者
Aline Dalmazo
Principal Investigator
Instituto de Cardiologia do Rio Grande do Sul