Human Intervention Studies Unit, Ulster University
Coleraine, Co.Londonderry, BT52 1SA, United Kingdom
NCT Number: NCT03765606
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Coleraine, Co.Londonderry, BT52 1SA, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Acute consumption of single portion of cocoa powder dissolved in 310g 1% milk.
Acute consumption of single portion of cocoa powder dissolved in 310g 1% milk.
Time frame: 24-hour period post-consumption
Recovery of ingested flavan-3-ols in ileal fluid
Time frame: Change over 8-hour period post-consumption
Uptake of ingested flavan-3-ols in plasma
Time frame: Change over 24-hour period post-consumption
Recovery of ingested flavan-3-ols in urine
Time frame: Change over 24-hour in vitro fermentation period
Ileal fluid with/without simulated colonic fermentation
University of Ulster
Other
The Bioavailability of Cocoa Flavan-3-ols and Interaction With the Methylxanthine, Theobromine: a Study With Ileostomists
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