NCT03906578进行中（未招募）不适用
Effect of a Probiotic on Blood Pressure in Low-to-moderate Risk Grade 1 Hypertension - a Randomized Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Nocturnal systolic blood pressure
研究概览
简要总结
High blood pressure is a major risk factor for cardiovascular events, including stroke, heart and kidney failure. Typical anti-hypertensive drugs target vessels, the kidneys or the heart. Here we propose a randomized, placebo-controlled study to test the blood pressure-lowering effect of a probiotic in 110 patients with grade 1 hypertension. In addition, we will investigate glucose variability, fecal bacterial metabolome, peripheral blood effector T cell frequencies (%) and health-related quality of life.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and postmenopausal women
- •Treated or untreated hypertension (resting office blood pressure 130-159/80-99 mmHg)
- •BMI 18.5 - 34.9 kg/m^2
排除标准
- •Secondary causes of hypertension
- •Known target organ damage
- •10 years cardiovascular risk score of >20%
- •Established cardiovascular or renal disease
- •Other serious diseases
- •Recent use of antibiotics
- •Specialized diets, e.g. use of probiotics
- •Two inclusion criteria were changed in June 2021 to improve recruitment
- •Age was changed from 50-75 to 50-80 years
- •Resting blood pressure was changed from 140-159/90-99 to 130-159/80-99 mmHg
结局指标
主要结局
Nocturnal systolic blood pressure
时间窗: After 8 weeks compared to placebo and adjusted to baseline
Measured by 24h ABPM (mmHg)
次要结局
- Office systolic blood pressure(After 8 weeks compared to placebo and adjusted to baseline)
- Nocturnal diastolic blood pressure(After 8 weeks compared to placebo and adjusted to baseline)
- 24h systolic blood pressure(After 8 weeks compared to placebo and adjusted to baseline)
- 24h diastolic blood pressure(After 8 weeks compared to placebo and adjusted to baseline)
- Change in immune cell phenotypes(After 8 weeks compared to placebo and adjusted to baseline)
- PROMIS-29 domain physical function(After 8 weeks compared to placebo and adjusted to baseline)
- PROMIS-29 domain fatigue(After 8 weeks compared to placebo and adjusted to baseline)
- PROMIS-29 domain ability to participate in social roles and activities(After 8 weeks compared to placebo and adjusted to baseline)
- Office diastolic blood pressure(After 8 weeks compared to placebo and adjusted to baseline)
- Gut microbiome(After 8 weeks compared to placebo and adjusted to baseline)
- PROMIS-29 domain depression(After 8 weeks compared to placebo and adjusted to baseline)
- PROMIS-29 domain anxiety(After 8 weeks compared to placebo and adjusted to baseline)
- Reduction of antihypertensive medication(After 8 weeks compared to placebo and adjusted to baseline)
- Glucose variability after standardized breakfasts(After 8 weeks compared to placebo and adjusted to baseline)
- Metabolomics stool and serum(After 8 weeks compared to placebo and adjusted to baseline)
- PROMIS-29 domain pain interference(After 8 weeks compared to placebo and adjusted to baseline)
- PROMIS-29 domain sleep disturbance(After 8 weeks compared to placebo and adjusted to baseline)
研究者
Kristin Kraeker
Principal Investigator
Charite University, Berlin, Germany
研究点 (2)
Loading locations...
相似试验
暂停
不适用
Effect of Probiotics on Blood Pressure ManagementHypertensionNCT03973710Sun Yat-sen University40
已完成
早期 1 期
Effect of Probiotics on Primary HypertensionHypertensionNCT05095350Chinese Academy of Medical Sciences, Fuwai Hospital115
已完成
不适用
The Role of Gut Microbiota in HypertensionHypertensionNCT02188381University of Florida292
已完成
不适用
The Role of a Combination of Nutraceuticals in the Control of Cardiovascular RiskMetabolic SyndromeNCT01293162Federico II University150
Unknown
早期 1 期
Salt and Gut StudyHigh Blood PressureNCT04958148Augusta University40