Clinical trial NCT03765606: Cocoa Ileostomy Study
Official title: The Bioavailability of Cocoa Flavan-3-ols and Interaction With the Methylxanthine, Theobromine: a Study With Ileostomists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ileostomy - Stoma
Keywords: Cocoa Flavan-3-ols
methylaxanthin
theobromine
Ileostomists
bioavailability
randomised controlled trial
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: University of California, Davis
First posted: 2018-12-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised double-blinded crossover
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Has not undergone an ileostomy and/or is less than 1.5 year post-operative
* Pregnant/ lactating females
* Smokers
* Lactose/milk/diary intolerant

Primary outcomes:
measure: cocoa flavan-3-ols bio-availability
timeFrame: 24-hour period post-consumption
measure: cocoa flavan-3-ols bio-availability
timeFrame: Change over 8-hour period post-consumption
measure: cocoa flavan-3-ols availability
timeFrame: Change over 24-hour period post-consumption
Secondary outcomes:
measure: Simulated gut microbiota
timeFrame: Change over 24-hour in vitro fermentation period
Other outcomes:
Locations:
city: Coleraine
country: United Kingdom
facility: Human Intervention Studies Unit, Ulster University
state: Co.Londonderry
Study officials:
References: