The Bioavailability of Cocoa Flavan-3-ols and Interaction With the Methylxanthine, Theobromine: a Study With Ileostomists
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Ulster
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- cocoa flavan-3-ols bio-availability
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Double-blinded
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Lactose/milk/diary intolerant
Arms & Interventions
Cocoa Flavanol beverage mix
Cocoa Flavanol beverage mix (flavanols, 566mg; caffeine, 11mg & theobromine, 93mg)
Intervention: 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)
Intervention: De-xanthinated Cocoa Flavanol beverage mix (Dietary Supplement)
Outcomes
Primary Outcomes
cocoa flavan-3-ols bio-availability
Time Frame: Change over 8-hour period post-consumption
Uptake of ingested flavan-3-ols in plasma
cocoa flavan-3-ols availability
Time Frame: Change over 24-hour period post-consumption
Recovery of ingested flavan-3-ols in urine
cocoa flavan-3-ols bio-availability
Time Frame: 24-hour period post-consumption
Recovery of ingested flavan-3-ols in ileal fluid
Secondary Outcomes
- Simulated gut microbiota(Change over 24-hour in vitro fermentation period)
