Cocoa Ileostomy Study

Not Applicable

Completed

• Conditions: Ileostomy - Stoma
• Interventions: Dietary Supplement: De-xanthinated Cocoa Flavanol beverage mix; Dietary Supplement: Cocoa Flavanol beverage mix

• Registration Number: NCT03765606
• Lead Sponsor: University of Ulster

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-09
• Primary Completion: 2018-05-04
• Study Completion: 2018-05-04
• Status Verified: 2018-06
• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-04
• Last Update Submitted: 2018-12-04
• Study First Posted: 2018-12-05
• Last Update Posted: 2018-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
De-xanthinated Cocoa Flavanol beverage mix	De-xanthinated Cocoa Flavanol beverage mix	De-xanthinated Cocoa Flavanol beverage mix (flavanols, 583mg; caffeine, 0.6mg \& theobromine, 0.2mg)
Cocoa Flavanol beverage mix	Cocoa Flavanol beverage mix	Cocoa Flavanol beverage mix (flavanols, 566mg; caffeine, 11mg \& theobromine, 93mg)

Primary Outcome Measures

Name	Time	Method
cocoa flavan-3-ols bio-availability	Change over 8-hour period post-consumption	Uptake of ingested flavan-3-ols in plasma
cocoa flavan-3-ols availability	Change over 24-hour period post-consumption	Recovery of ingested flavan-3-ols in urine

Secondary Outcome Measures

Name	Time	Method
Simulated gut microbiota	Change over 24-hour in vitro fermentation period	Ileal fluid with/without simulated colonic fermentation

Trial Locations

Locations (1)

Human Intervention Studies Unit, Ulster University; 🇬🇧 Coleraine, Co.Londonderry, United Kingdom