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Cocoa Ileostomy Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03765606
Enrollment
10
Registered
2018-12-05
Start date
2018-04-09
Completion date
2018-05-04
Last updated
2018-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ileostomy - Stoma

Keywords

Cocoa Flavan-3-ols, methylaxanthin, theobromine, Ileostomists, bioavailability, randomised controlled trial

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.

Interventions

DIETARY_SUPPLEMENTCocoa Flavanol beverage mix

Acute consumption of single portion of cocoa powder dissolved in 310g 1% milk.

DIETARY_SUPPLEMENTDe-xanthinated Cocoa Flavanol beverage mix

Acute consumption of single portion of cocoa powder dissolved in 310g 1% milk.

Sponsors

University of California, Davis
CollaboratorOTHER
University of Ulster
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Double-blinded

Intervention model description

Randomised double-blinded crossover

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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 * Smokers * Lactose/milk/diary intolerant

Design outcomes

Primary

MeasureTime frameDescription
cocoa flavan-3-ols bio-availability24-hour period post-consumptionRecovery of ingested flavan-3-ols in ileal fluid
cocoa flavan-3-ols availabilityChange over 24-hour period post-consumptionRecovery of ingested flavan-3-ols in urine

Secondary

MeasureTime frameDescription
Simulated gut microbiotaChange over 24-hour in vitro fermentation periodIleal fluid with/without simulated colonic fermentation

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026