Cocoa ileostomy Study
Research type
Research Study
Full title
The bioavailability of cocoa flavan-3-ols and interaction with the methylxanthine, theobromine: a study with ileostomists.
IRAS ID
240794
Contact name
Chris IR Gill
Contact email
Sponsor organisation
Ulster University
Clinicaltrials.gov Identifier
FCBMS-17-099, Biomedical Sciences Ethics Filter Committee
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Title: The bioavailability of cocoa flavan-3-ols and interaction with the methylxanthine, theobromine: a study with ileostomists.
There is a lot of interest in the potential role of chocolate and its primary bioactive components, the flavan-3-ols in prevention and management of CVD. Several observational studies support the links between high cocoa intake and reduced CVD risk and mortality. Cocoa flavan-3-ols need to be absorbed in the body in a form that maintains beneficial characteristics. Feeding studies with ileostomates who have had their colon surgically removed provide such information regarding the bioavailability and bioactivity of flavan-3-ols and related compounds from cocoa, which would pass from the small intestine to the colon in individuals with a complete gastrointestinal tract. Importantly, evidence suggests flavan-3-ol bioavailability is enhanced by the presence of the methylxanthine, theobromine, which occurs naturally in cocoa products. Therefore, the aim of this study will be to determine the impact of methylaxanthine (theobromine) on bioavailability of cocoa flavan-3-ols prior to entering the colon.
To assess this effect in vivo we will feed 20 participants who have previously had an ileostomy (removal of colon, > 1.5 years post-operative) a cocoa milk drink containing flavan-3-ols (~580 mg) with and without theobromine in an acute randomised double blind crossover design (2 x 2 day visits). We will collect (in a University Human interventions suite) blood, ileal fluid and urine samples at designated time points before and after supplementation and analyse the composition of these bio-fluids to determine the impact of theobromine on the bioavailability of cocoa flavan-3-ols.REC name
Wales REC 1
REC reference
18/WA/0056
Date of REC Opinion
26 Feb 2018
REC opinion
Further Information Favourable Opinion