The Bioavailability of Cocoa Flavan-3-ols and Interaction With the Methylxanthine, Theobromine: a Study With Ileostomists
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- cocoa flavan-3-ols bio-availability
研究概览
简要总结
There is substantial interest in the potential role of chocolate and its primary bioactive component; flavan-3-ol, (-)-epicatechin, in both the prevention and management of cardiovascular disease (CVD). Numerous observational studies have found the association between high cocoa intake and a reduced CVD risk and mortality, yet the impact of these mechanisms in vivo is unclear. In order to have a beneficial effect, these cocoa flavan-3-ols must be absorbed in the body in a forms, while still maintaining its advantageous characteristics. Consumption studies with ileostomists who have had their colon removed,provide information regarding the bioavailability and bioactivity of (-)-epicatechin and flavan-3-ols from cocoa, therefore the aim of this study is to determine the impact of methylaxanthines (including theobromine) on bioavailability of cocoa flavan-3-ols prior to entering the colon.
This study has a randomised double blinded crossover control design, being applied to ileostomy patients who are aged 18-65 years, N=10, 5 per group. The study is divided into two phases. During the first phase, subjects will partake in a 2-day restriction diet (No phenolic foods) and an overnight fast prior to sampling. Ileal fluid (0hr) is obtained from participants. They will then be asked to consume the cocoa flavanol beverage dissolved in 310g 1% milk. After this urine and ieal fluid is collected every 4 hours at 3 more time points and blood every hour at 8 time points. A 24 hr urine and ieal fluid sample is collected the following day. There will be a 1-week wash out period between each phase. Procedure is repeated again for phase 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double-blinded
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Undergone an ileostomy and be more than 1.5-years post-operative
- •Male or female
- •Aged between 18-65 years
- •Non-smoking
- •Not lactose/milk/dairy intolerant
排除标准
- •Has not undergone an ileostomy and/or is less than 1.5 year post-operative
- •Pregnant/ lactating females
- •Lactose/milk/diary intolerant
研究组 & 干预措施
Cocoa Flavanol beverage mix
Cocoa Flavanol beverage mix (flavanols, 566mg; caffeine, 11mg & theobromine, 93mg)
干预措施: Cocoa Flavanol beverage mix (Dietary Supplement)
De-xanthinated Cocoa Flavanol beverage mix
De-xanthinated Cocoa Flavanol beverage mix (flavanols, 583mg; caffeine, 0.6mg & theobromine, 0.2mg)
干预措施: De-xanthinated Cocoa Flavanol beverage mix (Dietary Supplement)
结局指标
主要结局
cocoa flavan-3-ols bio-availability
时间窗: Change over 8-hour period post-consumption
Uptake of ingested flavan-3-ols in plasma
cocoa flavan-3-ols availability
时间窗: Change over 24-hour period post-consumption
Recovery of ingested flavan-3-ols in urine
次要结局
- Simulated gut microbiota(Change over 24-hour in vitro fermentation period)
