Cardiovascular Health Arterial Stiffness Raspberry and Microbiome (CHARM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Change in flow-mediated dilation (FMD)
研究概览
简要总结
In this study, the investigators aim to determine the health benefits of red raspberry ellagitannin consumption on cardiovascular health. The study population is stratified according to the urolithin metabotypes (gut-microbial metabolic profile): UM-0, UM-A and UM-B.
The investigators will evaluate changes in blood pressure, endothelial function, arterial stiffness, lipid profile, cognitive performance and gut microbiome composition.
详细描述
Red raspberries are a good source of polyphenols including ellagitannins. Previous work suggests that urolithins, gut microbial metabolites derived from ellagitannins contained in raspberries, can improve vascular health. It has also been observed that the capacity of the gut microbiome to metabolize urolithins can influence the cardiometabolic response to ellagitannin consumption. In this work the investigators aim to investigate whether urolithin metabotypes (UM-A, B and 0) can influence the vascular response to a (poly)phenol-rich breakfast containing red raspberry ellagitannins in a healthy UK population.
You will be stratified by metabotype in a first phase (NCT03573414) and are then randomly allocated to treatment or placebo. Outcomes are measured at baseline and after 12 weeks consumption of the study product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men or women aged 20-70 years old
- •BMI between 18.5-35 kg/m²
- •Normotensive: SBP lower than 140 mmHg or DBP lower than 90 mmHg
- •Willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study
- •Able to understand the nature of the study
- •Able to give signed written informed consent
排除标准
- •Have required treatment for hypertension at any time (e.g. statins, aspirin, blood pressure lowering drugs)
- •BMI outside range
- •Manifest cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral artery disease
- •Currently treated with a diet
- •Chronic-acute disease
- •Unstable psychological condition
- •Diabetes mellitus, metabolic syndrome, acute inflammation, terminal renal failure, malignancies or abnormal heart rhythm (lower or higher than 60-100 bpm)
- •History of cancer, myocardial infarction, cerebrovascular incident or kidney abnormality
- •Allergies to berries, flax seeds and soy milk or other significant food allergy
- •Requiring chronic antimicrobial or antiviral treatment
- •Reported having taken food supplements, dietary supplement or herbal remedies within 1 month of study start
- •Weight loss of more than 10% body weight in the previous 6 months
- •Reported participant in another study within one month before the study start
- •Smoke an irregular amount of cigarettes per day or planning to quit smoking in the next 3 months
- •Unable to tolerate breakfast ingestion
- •Pregnant woman/ lactating woman/ woman planning to become pregnant/ premenopausal women who do not have a regular menstrual cycle/ premenopausal women who do not have 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
- •Unable to swallow the capsule.
结局指标
主要结局
Change in flow-mediated dilation (FMD)
时间窗: Baseline vs 12 weeks post-consumption
Determine the effect of the Red raspberry ellagitannin extract vs Placebo on flow-mediated dilation at 12 weeks post consumption
次要结局
- Change in blood lipid concentrations(Baseline vs 12 weeks post-consumption)
- Change in office blood pressure(Baseline vs 12 weeks post-consumption)
- Change in heart rate(Baseline vs 12 weeks post-consumption)
- Change in 24-hour AIx and PWV(Baseline vs 12 weeks post-consumption)
- Change in 24-hour heart rate(Baseline vs 12 weeks post-consumption)
- Change in blood flow velocity(Baseline vs 12 weeks post-consumption)
- Change in pulse wave velocity (PWV)(Baseline vs 12 weeks post-consumption)
- Change in augmentation Index (AIx)(Baseline vs 12 weeks post-consumption)
- Change in blood inflammatory markers (circulating concentrations)(Baseline vs 12 weeks post-consumption)
- Change in 24-hour ambulatory blood pressure(Baseline vs 12 weeks post-consumption)
研究者
Dr Ana Rodriguez-Mateos
Reader in Nutritional Sciences
King's College London