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Clinical Trials/NCT03765606
NCT03765606CompletedNot Applicable

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

University of Ulster1 site in 1 country10 target enrollmentStarted: April 9, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Placebo Comparator

Cocoa Flavanol beverage mix (flavanols, 566mg; caffeine, 11mg & theobromine, 93mg)

Intervention: Cocoa Flavanol beverage mix (Dietary Supplement)

De-xanthinated Cocoa Flavanol beverage mix

Experimental

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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