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Completed

NCT Number: NCT03765606

Cocoa Ileostomy Study

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Intervention Studies Unit, Ulster University

Coleraine, Co.Londonderry, BT52 1SA, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cocoa Flavanol beverage mix

Dietary Supplement

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

De-xanthinated Cocoa Flavanol beverage mix

Dietary Supplement

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

Primary outcomes

  1. cocoa flavan-3-ols bio-availability

    Time frame: 24-hour period post-consumption

    Recovery of ingested flavan-3-ols in ileal fluid

  2. cocoa flavan-3-ols bio-availability

    Time frame: Change over 8-hour period post-consumption

    Uptake of ingested flavan-3-ols in plasma

  3. cocoa flavan-3-ols availability

    Time frame: Change over 24-hour period post-consumption

    Recovery of ingested flavan-3-ols in urine

Secondary outcomes

  1. Simulated gut microbiota

    Time frame: Change over 24-hour in vitro fermentation period

    Ileal fluid with/without simulated colonic fermentation

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Collaborators

  • University of California, Davis

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 5, 2018
Registry last updated
Dec 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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