The Effects of Polyphenol-rich Berry Juice on Blood Pressure and Additional CVD Related Parameters in Pre-hypertensive Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Systolic and diastolic blood pressure
研究概览
简要总结
The purpose of this study is to investigate the effects of berry juices containing different levels of polyphenols on blood pressure and other cardiovascular risk factors.
The study is a 12 week double blinded randomized controlled intervention trial. The subjects will be divided in three groups where one receives a placebo juice while the two other will consume 0.5 liter of juice containing different levels of polyphenols. Blood pressure will be monitored and blood samples will be taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pre-hypertension or hypertension systolic blood pressure in the 130-179 mmHg range and/or diastolic blood pressure in the 85-109 mmHg range)
- •BMI 20-35 kg/m2
- •Stable weight (change <4 kg previous 12 weeks)
排除标准
- •Regular use of blood pressure lowering agens
- •Diabetes type I or II
- •Allergy to grape, cherries, blueberries/bilberries, black currant, aronia
- •Supplements for weight loss
- •Changes in pharmacological treatment of hyperlipidemia or hyperglycemia (initiation, termination or changes in dosage) last 30 days prior to inclusion or during the study period (run-in and intervention)
- •Participation in a drug trial during the previous 30 days
结局指标
主要结局
Systolic and diastolic blood pressure
时间窗: Screening, baseline, 6 and 12 weeks
Change in blood pressure from baseline to 6 weeks and 12 weeks
Platelet aggregation
时间窗: Baseline and 12 weeks
Change in platelet aggregation from intervention start till end analyzed by PFA100.
Cardiovascular disease risk factors
时间窗: Baseline and 12 weeks
The effect of polyphenole-rich diet on cardiovascular disease risk factors in blood samples will be analyzed.
Diabetes related parameters in blood and urine
时间窗: Baseline and 12 weeks
The effect of different doses and types of polyphenoles on diabetes related biomarkers in blood and urine will be analyzed.
Blood cell expression of stress-response and CVD related genes
时间窗: Baseline and 12 weeks
Effect of polyphenole-rich diet on blood cell expression of stress-response and cardiovascular disease related genes by low density array and/or whole genome expression (microarray).
次要结局
- Polymorphisms in cardiovascular disease related genes(Baseline)
- Whole genome transcription profiles and methylation patterns(Baseline and 12 weeks)
研究者
Rune Blomhoff
Professor
University of Oslo