Cocoa Ileostomy Study

Ulster University

Status: Completed

Conditions: Ileostomy - Stoma

Treatments: Dietary Supplement: De-xanthinated Cocoa Flavanol beverage mix; Dietary Supplement: Cocoa Flavanol beverage mix

Study type: Interventional

Funder types: Other

Identifiers

NCT03765606

UREC/18/0007

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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10 participants in 2 patient groups, including a placebo group

Cocoa Flavanol beverage mix

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Cocoa Flavanol beverage mix

De-xanthinated Cocoa Flavanol beverage mix

Experimental group

Description:

De-xanthinated Cocoa Flavanol beverage mix (flavanols, 583mg; caffeine, 0.6mg \& theobromine, 0.2mg)

Treatment:

Dietary Supplement: De-xanthinated Cocoa Flavanol beverage mix