Ignite Creation Date:
2024-05-06 @ 12:26 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03765606
Status:
COMPLETED
Last Update Posted:
2018-12-05
First Post:
2018-12-04
Brief Title:
Cocoa Ileostomy Study
Sponsor:
University of Ulster
Organization:
University of Ulster
Study Overview
Official Title:
The Bioavailability of Cocoa Flavan-3-ols and Interaction With the Methylxanthine Theobromine a Study With Ileostomists
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 removedprovide 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 N10 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
This study has a randomised double blinded crossover control design being applied to ileostomy patients who are aged 18-65 years N10 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None