Effect of a Probiotic on Blood Pressure in Low-to-moderate Risk Grade 1 Hypertension - a Randomized Study
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
- 1
- 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
研究组 & 干预措施
Probiotic
Two sachets Vivomixx® containing 8 strains of life bacteria (9 x 10^11 CFU) in the evening for 8 weeks
干预措施: Vivomixx® (Dietary Supplement)
Placebo
Two sachets placebo in the evening for 8 weeks
干预措施: Placebo (Other)
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
- Nocturnal diastolic blood pressure(After 8 weeks compared to placebo and adjusted to baseline)
- Reduction of antihypertensive medication(After 8 weeks compared to placebo and adjusted to baseline)
- Office systolic 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)
- 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