Effects of Aronia Berry (Chokeberry) Extract on Vascular Function in Healthy Men: a 3 Month Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Flow-mediated dilation
研究概览
简要总结
There is an increasing interest in the effects of various food derived polyphenols on vascular function. Arguably the most well-established vascular benefits are attributed to flavanols from cocoa beans and this has been supported by a successful health claim through the European Food Safely Authority in 2012. Berry fruits are another rich source of polyphenols that have vasoactive properties, and there is a growing body of research exploring these effects in various berries (blueberries, cranberries, strawberries) and other fruit products with similar polyphenol composition. A key (poly)phenol in berries and other fruits believed to provide much of the benefit is anthocyanins. When given as an isolated extract, 320 mg anthocyanins have been found to improve blood vessel function both acutely and in response to chronic consumption over 12 weeks.
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 extracts of differing polyphenol dose on vascular endothelial function.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy men aged 18-45 years old
- •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 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
- •Hypertensive, 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
- •Terminal renal failure
- •Malignancies
- •Abnormal heart rhythm (lower or higher than 60-100 bpm)
- •Allergies to berries or other significant food allergy.
- •Subjects under medication or on vitamin/dietary supplements.
- •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 one month before the study start
- •Subjects who smoke an irregular amount of cigarettes per day
- •Unable to swallow the capsule
- •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 full spectrum
Formulation of an aronia full spectrum ingredient in a 1-hard capsule regimen (500 mg)
干预措施: Aronia full spectrum (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
Flow-mediated dilation
时间窗: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Change form Baseline Endothelial function at 12 weeks
次要结局
- Pulse wave velocity(Baseline and 12 weeks)
- Blood pressure(Baseline and 12 weeks)
- Blood measurements- Blood lipids(Baseline and 12 weeks)
- Blood measurements-Electrolytes(Baseline and 12 weeks)
- Blood measurements -Glucose(Baseline and 12 weeks)
- Blood measurements(Baseline and 12 weeks)
研究者
Dr Ana Rodriguez-Mateos
Principal investigator
King's College London