Evaluation of the Effect of Chokeberry (Aronia Melanocarpa) Polyphenols on Blood Pressure in Prehypertensive Healthy Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 4
- 主要终点
- Changes from baseline ambulatory blood pressure after 12-week consumption
研究概览
简要总结
Aronia berries are a native North American berry with high naturally occurring anthocyanins among other polyphenols. Based on their polyphenol composition, there is growing interest in the potential for Aronia berries to elicit health promoting cardio-metabolic effects. Specifically, Aronia berry extracts, which provide a concentrated source of polyphenols, may improve blood vessel function.
Thus, the primary focus of this project is to evaluate the effects of Aronia berry polyphenols on blood pressure and other biomarkers of cardiovascular disease risk such as endothelial function, arterial stiffness and blood lipids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women aged 40-70 years old
- •Blood pressure comprised between: SBP 120/139 mmHg or DBP 80/89 mmHg
- •Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study
- •Are able to understand the nature of the study
- •Able and willing to give signed written informed consent
- •Signed informed consent form
排除标准
- •Manifest cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral artery disease
- •Grade 1 hypertensive or above, as defined as SBP superior or equal to 140 mmHg or DBP superior or equal to 90 mmHg
- •Obese participants, defined as BMI superior or equal to 30
- •Diabetes mellitus and metabolic syndrome
- •Acute inflammation
- •Chronic and acute disease
- •Terminal renal failure and other kidney abnormalities
- •Malignancies
- •Abnormal heart rhythm
- •Allergies to berries or other significant food allergy.
- •Subjects who require treatment for hypertension at any time (e.g. statins, aspirin, blood pressure lowering drugs)
- •Subjects who took food supplements, dietary supplement or herbal remedies within 1 month of study start
- •Subjects who have lost more than 10% of their weight in the past 6 months or are currently in a diet
- •Subjects who reported participant in another study within 1 month before the study start
- •Subjects who smoke an irregular amount of cigarettes per day
- •Subjects who require chronic antimicrobial or antiviral treatment
- •Subjects with unstable psychological condition
- •Subjects with history of cancer, myocardial infarction, cerebrovascular incident
- •Unable to swallow the capsule
- •Pregnant, lactating or planning to become pregnant, as well as premenopausal women who do not have an adequate method of contraception
- •Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements.
研究组 & 干预措施
Placebo
Formulation containing inert artificially colored maltodextrin, once daily, in a 1-hard capsule regimen (500 mg)
干预措施: Placebo (Dietary Supplement)
Aronia extract
Formulation of an aronia extract ingredient in a 1-hard capsule regimen (500 mg)
干预措施: Aronia extract (Dietary Supplement)
结局指标
主要结局
Changes from baseline ambulatory blood pressure after 12-week consumption
时间窗: Baseline and 12 weeks
Determine the effect of the Aronia extract vs Placebo on ambulatory 24-hour systolic and diastolic blood pressure at 12 weeks post consumption, compared to the baseline.
次要结局
- Blood lipids(Baseline and 12 weeks)
- Number of volunteers with treatment-related adverse events(Baseline and 12 weeks)
- Blood flow velocity(Baseline 0 and 2 hours and 12 weeks 0 and 2 hours)
- Pulse wave velocity (PWV)(Baseline 0 and 2 hours and 12 weeks 0 and 2 hours)
- Heart rate(Baseline 0 and 2 hours and 12 weeks 0 and 2 hours)
- Blood cortisol(Baseline and 12 weeks)
- Augmentation Index (AIx)(Baseline 0 and 2 hours and 12 weeks 0 and 2 hours)
- Office blood pressure(Baseline 0 and 2 hours and 12 weeks 0 and 2 hours)
- Flow-mediated dilation(Baseline 0 and 2 hours and 12 weeks 0 and 2 hours)
- 24-hour heart rate(Baseline and 12 weeks)
研究者
Dr Ana Rodriguez-Mateos
Principal investigator
King's College London