Randomized, Double-blind, Placebo Controlled, Parallel Study to Evaluate the Effect of Concord Grape Extract on Vascular Function in Healthy Men and Women
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
- Changes in flow mediated dilation (FMD) of the brachial artery
研究概览
简要总结
Concord grape (Vitis Labrusca) is rich in polyphenols such as anthocyanins, flavanols, procyanidins and flavonols. Current reports investigating the effects of Concord grape (CG) consumption on cardiovascular disease (CVD) risk have provided mixed results. Studies were limited by small sample size or lacked a control arm. Moreover, subjects presented with CVD or CVD risk factors and thus to our knowledge, it remains unknown as to whether the consumption of Concord Grape (poly)phenols can maintain vascular function in healthy individuals. The aim of this study is therefore to examine both acute and chronic effects of Concord Grape on cardiovascular health by investigating whether daily consumption of Concord Grape Extract (CGE) for 12 weeks can affect biomarkers of CVD risk, including endothelial function, blood pressure and blood lipids, in young healthy men and women.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women (pre and post-menopausal) aged 18-40 years
- •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
- •Medical history of cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral artery disease
- •Hypertensive, as defined as SBP superior or equal to 140 mmHg
- •Obese participants, defined as BMI superior or equal to 30 kg/m2
- •Medical history of diabetes mellitus, metabolic syndrome, terminal renal failure or malignancies
- •Abnormal heart rhythm (lower or higher than 60-100 bmp)
- •Allergies to berries or other significant food allergy
- •Subjects under medication that can affect the cardiovascular system 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
- •Pregnant women or planning to become pregnant in the next 6 months
- •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 2-hard capsules regimen (1g)
干预措施: Placebo (Dietary Supplement)
Concord Grape Extract 1
1 g Concord Grape Extract in 2 capsules
干预措施: Concord Grape extract 1 (Dietary Supplement)
Concord Grape Extract 2
500 mg Concord Grape Extract in 2 capsules
干预措施: Concord Grape extract 2 (Dietary Supplement)
结局指标
主要结局
Changes in flow mediated dilation (FMD) of the brachial artery
时间窗: 12 weeks
Determine changes in flow mediated dilation (FMD) of the brachial artery after 12 week consumption of 500 mg or 1 g of Concord grape extract vs. Placebo
次要结局
- Changes in flow mediated dilation (FMD) of the brachial artery(2 hours)
研究者
Dr Ana Rodriguez-Mateos
Principle Investigator
King's College London