Effects of an Anthocyanin-rich Blackcurrant Beverage on Cardiovascular Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Change from baseline in platelet function measured by agonist-induced platelet aggregation
研究概览
简要总结
Regular consumption of fruits and vegetables may improve human health and reduce the risk of chronic diseases, such as heart disease, certain cancers and type 2 diabetes, but the active components and the underlying mechanisms are poorly understood. Berry fruits are abundant in anthocyanins and this study aims to test the hypothesis that ingestion of an anthocyanin-rich blackcurrant beverage will improve markers of cardiovascular health (health of blood vessels, inflammation and platelet function). Further, the study will investigate the anthocyanin bioavailability from the blackcurrant beverage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 30-55 years
- •Non-smoker
- •BMI between 20 - 30 kg/m2
- •Generally healthy as established by a 'health and lifestyle' questionnaire and a screening blood sample
- •Blood pressure < 140/90mmHg
- •Total cholesterol < 6.2 mmol/L
- •Fasting glucose < 7.0 mmol/L
排除标准
- •Diabetes mellitus
- •Heart problems, stroke, vascular disease
- •Inflammatory disease
- •Kidney, liver, pancreas or gastrointestinal diseases
- •Medication for hyperlipidaemia, hypertension, hypercoagulation, inflammatory conditions
- •Allergies
- •Smokers (social smokers who agree to abstain for 1 month before and during the study not excluded)
- •Taking phytochemical, antioxidant or fish oil supplements (unless willing to stop for the study period)
- •Taking aspirin > 2 times per month and unwilling to abstain from aspirin ingestion for 14 days prior each study visit
- •History of alcohol misuse
- •Consumption of alcohol >21 units (men) or >15 units (women)
- •Intense aerobic exercise >20 min 3 x per week
- •Participation in another clinical trial
- •Antibiotics in previous 3 months before study
- •Low haemoglobin levels
- •Females who are pregnant, lactating, or if of reproductive age and not using a reliable form of contraception (including abstinence)
结局指标
主要结局
Change from baseline in platelet function measured by agonist-induced platelet aggregation
时间窗: Acute study: measured at baseline and 2 and 4 h post intervention
Change from baseline in vascular reactivity measured by flow-mediated dilatation (FMD)
时间窗: Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention
次要结局
- Change from baseline in the concentration of polyphenols and their metabolites and degradants in blood and urine samples measured by HPLC-MS/MS(Acute study: plasma measured at baseline and 1, 2, 4, 6 and 24 h post intervention, urine measured at baseline and 1, 2, 4, 6 and 6-24 h post intervention)
- Change from baseline in vascular function measured by digital volume pulse (DVP)(Acute study: measured at baseline and 2, 4 and 6 h post intervention)
- Change from baseline in blood pressure(Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention)
- Change from baseline in the concentration of nitric oxide in plasma measured by ozone-based chemiluminescence(Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention)
- Change from baseline in the concentration of selected cytokines (TNF-a, IL-1b, IL-6, IL-8 and IL-10) in plasma measured using a cytometric bead array kit from BD Biosciences(Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention)
- Change from baseline in platelet function (numbers of circulating micro particles by nano particle tracking analysis)(Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention (urine metabonomics additionally 6-24h))
- Metabonomics on urine and plasma samples measured by nuclear magnetic resonance spectroscopy(Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention (urine metabonomics additionally 6-24h))
研究者
Professor Parveen Yaqoob, MA, DPhil, RNutr, FAfN
Professor Parveen Yaqoob
University of Reading