Cocoa Ileostomy Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Ileostomy - Stoma

Intervention / Treatment
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* Dietary Supplement: Cocoa Flavanol beverage mix
* Dietary Supplement: De-xanthinated Cocoa Flavanol beverage mix


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomised double-blinded crossover
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Cocoa Flavanol beverage mix<br>Cocoa Flavanol beverage mix (flavanols, 566mg; caffeine, 11mg & theobromine, 93mg) | Dietary Supplement: Cocoa Flavanol beverage mix<br>* Acute consumption of single portion of cocoa powder dissolved in 310g 1% milk.<br>|
| Experimental: De-xanthinated Cocoa Flavanol beverage mix<br>De-xanthinated Cocoa Flavanol beverage mix (flavanols, 583mg; caffeine, 0.6mg & theobromine, 0.2mg) | Dietary Supplement: De-xanthinated Cocoa Flavanol beverage mix<br>* Acute consumption of single portion of cocoa powder dissolved in 310g 1% milk.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cocoa flavan-3-ols bio-availability | Recovery of ingested flavan-3-ols in ileal fluid | 24-hour period post-consumption | 
| cocoa flavan-3-ols bio-availability | Uptake of ingested flavan-3-ols in plasma | Change over 8-hour period post-consumption | 
| cocoa flavan-3-ols availability | Recovery of ingested flavan-3-ols in urine | Change over 24-hour period post-consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Simulated gut microbiota | Ileal fluid with/without simulated colonic fermentation | Change over 24-hour in vitro fermentation period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cocoa Flavan-3-ols, methylaxanthin, theobromine, Ileostomists, bioavailability, randomised controlled trial