NCT01989702已完成不适用
The Effect of a Probiotic-based Product on Blood Pressure and Other Known Risk Factors Linked to Cardiovascular Diseases.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Probi AB
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Changes from baseline in systolic and diastolic blood pressure after 3 months of probiotic intervention
研究概览
简要总结
The aim of the present study was to examine the efficacy of a probiotic-based product on either reducing hypertension or preventing a high normal blood pressure from reaching hypertensive levels.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals at the age of 40-75 years.
- •Blood-pressure >140/90 mmHg that has been confirmed at 2-3 separate occasions or represents the mean value of a 24-hour measurement.
- •Triglycerides >1,7 mmol/L and/or HDL <1 mmol/L (men)/1,29 mmol/L (women).
- •Fasting plasma glucose levels >5,6 mmol/L and/or waist circumference >102 cm (men)/88 cm (women).
- •BMI <40.
排除标准
- •Medically treated allergy or allergy to any of the ingredients of the study product.
- •Medication for high levels of blood lipids.
- •Metabolic disease, such as type one diabetes.
- •Confirmed diseases of the heart, liver of kidneys.
- •Chronic inflammatory disease requiring medication.
- •Pregnant or nursing.
- •Regular intake of other probiotic products (5-7 days per week during the last three months before inclusion into the study).
结局指标
主要结局
Changes from baseline in systolic and diastolic blood pressure after 3 months of probiotic intervention
时间窗: Baseline, 3 months
次要结局
- Changes from baseline of blood parameters, such as inflammatory markers and blood lipids, linked to increased risk for cardiovascular diseases(Baseline, 3 months)
研究者
研究点 (1)
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