Cocoa Ileostomy Study

NCT03765606 | Completed

• 1 other identifier: UREC/18/0007
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Ileostomy - Stoma

Keywords

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

Outcome Measures

Primary Outcomes (3)

• cocoa flavan-3-ols bio-availability

  Recovery of ingested flavan-3-ols in ileal fluid

  24-hour period post-consumption

• cocoa flavan-3-ols bio-availability

  Uptake of ingested flavan-3-ols in plasma

  Change over 8-hour period post-consumption

• cocoa flavan-3-ols availability

  Recovery of ingested flavan-3-ols in urine

  Change over 24-hour period post-consumption

Secondary Outcomes (1)

• Simulated gut microbiota

  Change over 24-hour in vitro fermentation period

Study Arms (2)

Cocoa Flavanol beverage mix

PLACEBO COMPARATOR

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

Dietary Supplement: Cocoa Flavanol beverage mix

De-xanthinated Cocoa Flavanol beverage mix

EXPERIMENTAL

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

Dietary Supplement: De-xanthinated Cocoa Flavanol beverage mix

Interventions

Cocoa Flavanol beverage mix DIETARY_SUPPLEMENT

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

Cocoa Flavanol beverage mix

De-xanthinated 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Has not undergone an ileostomy and/or is less than 1.5 year post-operative
• Pregnant/ lactating females
• Smokers
• Lactose/milk/diary intolerant

Sponsors & Collaborators

• University of Ulster: lead
• University of California, Davis: collaborator

Study Sites (1)

Human Intervention Studies Unit, Ulster University

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

Location

Related Publications (1)

• Ottaviani JI, Fong RY, Borges G, Kimball J, Ensunsa JL, Medici V, Pourshahidi LK, Kane E, Ward K, Durkan R, Dobani S, Lawther R, O'Connor G, Gill CIR, Schroeter H, Crozier A. Flavan-3-ol-methylxanthine interactions: Modulation of flavan-3-ol bioavailability in volunteers with a functional colon and an ileostomy. Free Radic Biol Med. 2023 Feb 20;196:1-8. doi: 10.1016/j.freeradbiomed.2023.01.003. Epub 2023 Jan 5.

  PMID: 36621554 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised double-blinded crossover

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 5, 2018
• Study Start: April 9, 2018
• Primary Completion: May 4, 2018
• Study Completion: May 4, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)