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临床试验/NCT03765606
NCT03765606已完成不适用

The Bioavailability of Cocoa Flavan-3-ols and Interaction With the Methylxanthine, Theobromine: a Study With Ileostomists

University of Ulster2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年4月9日最近更新:
适应症
干预措施

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

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

Placebo Comparator

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

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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