Bioavailability and Vascular Effects of Apple Polyphenols
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Area under the plasma pharmacokinetic curve for total epicatechin
研究概览
简要总结
The main purpose of this study is to determine the oral bioavailability of flavanols (polyphenolic compounds) from apple granules and an apple extract delivered in a water based beverage at two different doses. We will also investigate the effects of apple flavanols on nitric oxide production.
详细描述
This study is a randomized four phase crossover trial investigating the bioavailability of apple flavanols and the effects on nitric oxide products, a surrogate marker for changes in endothelial function. Each test phase will comprise a 3 day period of intervention which will be identical in nature (except for the test product consumed) and separated by a minimum of 1 week. On days 1-3 of each test phase volunteers will consume a low flavanol diet. After consumption of the test product on the morning of day 2, blood and urine samples will be collected at regular intervals for the next 24h.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 45-70 years
排除标准
- •Smokers (or have quit smoking less than 1 year ago)
- •Regular prescribed medication (excluding some eye and skin medication that is judged not to affect study outcome)
- •Non-prescribed medication that may affect the study data, e.g. aspirin. The use of non prescribed medications will be assessed on an individual basis.
- •Dietary supplements or herbal remedies which may affect the study data unless the volunteer is willing to discontinue them for 1 month prior to starting study. (Please note that some supplements may not affect the study and this will be assessed on an individual basis).
- •Gastro-intestinal diseases (excluding hiatus hernia unless symptomatic or study intervention/procedure is contra-indicated).
- •Diabetics
- •Known cardiovascular disease
- •Asthmatics (unless no medication taken for 1 year)
- •Lactose Intolerance
- •Pregnancy or have been pregnant within the last 12 months
- •Parallel participation in another research project which involves dietary intervention
- •Participation in another research project which has involved blood sampling within the last four months unless the total amount of combined blood from both studies does not exceed 470 mls.
- •Has donated or intends to donate blood within 16 weeks prior to or during the study period.
- •Depressed or elevated blood pressure measurements (<90/50 or 95/55 if symptomatic or >160/100)
- •Any person related to or living with any member of the study team
- •Results of the clinical screening which indicate or are judged by the HNU Medical Advisor to be indicative of a health problem which could compromise the well-being of the volunteer if they participated or which could affect the study data.
- •Alcohol consumption > approximately 20 g alcohol/day (2.5 units/day)
- •BMI <19.5 or > 35
结局指标
主要结局
Area under the plasma pharmacokinetic curve for total epicatechin
时间窗: 24 hours
次要结局
- Additional measures of bioavailability: Plasma Cmax, Tmax, half life and urinary excretion(24 hours)
- Changes in levels of nitric Oxide metabolites as a surrogate measure of endothelial function after consumption of apple flavanols(24 hours)