Gut Microbial Metabolism of Polyphenols and Cardiovascular Health
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Plasma and 24 h urine gut microbial polyphenol metabolites after high polyphenol breakfast.
研究概览
简要总结
There is increasing interest in the effects of various food derived polyphenols on cardiovascular health. Several studies have demonstrated improvements in vascular function after intake of polyphenol rich foods. The objective of this study is to investigate the association between polyphenol microbiota metabolism and cardiovascular health.
The participants (n=250) with age range between 20 to 70 years old health overweight men and women. The participants will consume a polyphenol rich breakfast for three days (consisting on milled flaxseed, raspberry powder and soy milk). The participants will provide the investigators with urine and blood samples for polyphenol analysis. Cardiovascular measurements such as PWV, AIx, Blood Pressure and FMD will be performed at baseline and after 72h.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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 and women aged 20-70 years
- •BMI between 18.5 and 35 kg/m2
- •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, defined as 140/90mmHg or higher
- •Obese participants with BMI superior or equal to 35 kg/m2
- •Underweight participants defined by a BMI inferior to 18.5 kg/m2
- •Medical history of diabetes mellitus, metabolic syndrome, terminal renal failure or malignancies
- •Abnormal heart rhythm (lower or higher than 60-100 bpm)
- •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.
结局指标
主要结局
Plasma and 24 h urine gut microbial polyphenol metabolites after high polyphenol breakfast.
时间窗: 1-3 days
To examine ellagitannins, lignans and isoflavones metabolites levels in urine and plasma assessed by liquid chromatography - mass spectrometer (LCMS) post 3 days consumption of high polyphenol breakfast contain 40 g raspberry powder, 30 g milled flaxseed and 250 mL soy milk to establish metabotypes.
次要结局
- Changes in heart rate after 3 days consumption of high polyphenol breakfast.(Baseline 0 and 72 hours.)
- Plasma and Urine polyphenol metabolites levels for ellagitannins, lignans and isoflavones.(Baseline 0 and 72 hours)
- Changes in flow- mediated dilation after 3 days consumption of high polyphenol breakfast.(Baseline 0 and 72 hours.)
- Changes in augmentation Index (AIx) after 3 days consumption of high polyphenol breakfast.(Baseline 0 and 72 hours.)
- Changes in Pulse Wave Velocity (PWV) after 3 days consumption of high polyphenol. breakfast(Baseline 0 and 72 hours.)
- Changes in office Blood pressure after 3 days consumption of high polyphenol breakfast.(Baseline 0 and 72 hours.)
研究者
Dr Ana Rodriguez-Mateos
Lecturer in Nutrition
King's College London