Cocoa Ileostomy Study

Ileostomy - Stoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03765606
• Other study ID #: UREC/18/0007
• Status: Completed
• Phase: N/A
• Start date: April 9, 2018
• Est. completion date: May 4, 2018

Study information

• Verified date: June 2018
• Source: University of Ulster
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 4, 2018
• Est. primary completion date: May 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Ileostomy - Stoma

Intervention

Dietary Supplement:
• Cocoa Flavanol beverage mix
Acute consumption of single portion of cocoa powder dissolved in 310g 1% milk.
• De-xanthinated Cocoa Flavanol beverage mix
Acute consumption of single portion of cocoa powder dissolved in 310g 1% milk.

Locations

Country	Name	City	State
United Kingdom	Human Intervention Studies Unit, Ulster University	Coleraine	Co.Londonderry

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulster	University of California, Davis

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cocoa flavan-3-ols bio-availability	Recovery of ingested flavan-3-ols in ileal fluid	24-hour period post-consumption
Primary	cocoa flavan-3-ols bio-availability	Uptake of ingested flavan-3-ols in plasma	Change over 8-hour period post-consumption
Primary	cocoa flavan-3-ols availability	Recovery of ingested flavan-3-ols in urine	Change over 24-hour period post-consumption
Secondary	Simulated gut microbiota	Ileal fluid with/without simulated colonic fermentation	Change over 24-hour in vitro fermentation period