Cocoa Ileostomy Study

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

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 Overview

• Status: Completed
• Conditions: Ileostomy - Stoma
• Intervention / Treatment: Dietary supplement: Cocoa Flavanol beverage mix; Dietary supplement: De-xanthinated Cocoa Flavanol beverage mix

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Co.Londonderry
    • Coleraine, Co.Londonderry, United Kingdom, BT52 1SA
      • Human Intervention Studies Unit, Ulster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Ulster
• Collaborators: University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2018
• Primary Completion (Actual): May 4, 2018
• Study Completion (Actual): May 4, 2018

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): December 5, 2018
• Last Update Submitted That Met QC Criteria: December 4, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: bioavailability; randomised controlled trial; Ileostomists; Cocoa Flavan-3-ols; methylaxanthin; theobromine
• Other Study ID Numbers: UREC/18/0007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No