Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
Study NCT ID:
NCT03765606
Status:
COMPLETED
Last Update Posted:
2018-12-05
First Post:
2018-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cocoa Ileostomy Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blinded'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomised double-blinded crossover'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-04', 'studyFirstSubmitDate': '2018-12-04', 'studyFirstSubmitQcDate': '2018-12-04', 'lastUpdatePostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cocoa flavan-3-ols bio-availability', 'timeFrame': '24-hour period post-consumption', 'description': 'Recovery of ingested flavan-3-ols in ileal fluid'}, {'measure': 'cocoa flavan-3-ols bio-availability', 'timeFrame': 'Change over 8-hour period post-consumption', 'description': 'Uptake of ingested flavan-3-ols in plasma'}, {'measure': 'cocoa flavan-3-ols availability', 'timeFrame': 'Change over 24-hour period post-consumption', 'description': 'Recovery of ingested flavan-3-ols in urine'}], 'secondaryOutcomes': [{'measure': 'Simulated gut microbiota', 'timeFrame': 'Change over 24-hour in vitro fermentation period', 'description': 'Ileal fluid with/without simulated colonic fermentation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cocoa Flavan-3-ols', 'methylaxanthin', 'theobromine', 'Ileostomists', 'bioavailability', 'randomised controlled trial'], 'conditions': ['Ileostomy - Stoma']}, 'referencesModule': {'references': [{'pmid': '36621554', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergone an ileostomy and be more than 1.5-years post-operative\n* Male or female\n* Aged between 18-65 years\n* Non-smoking\n* Not lactose/milk/dairy intolerant\n\nExclusion Criteria:\n\n* Has not undergone an ileostomy and/or is less than 1.5 year post-operative\n* Pregnant/ lactating females\n* Smokers\n* Lactose/milk/diary intolerant'}, 'identificationModule': {'nctId': 'NCT03765606', 'briefTitle': 'Cocoa Ileostomy Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulster'}, 'officialTitle': 'The Bioavailability of Cocoa Flavan-3-ols and Interaction With the Methylxanthine, Theobromine: a Study With Ileostomists', 'orgStudyIdInfo': {'id': 'UREC/18/0007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Cocoa Flavanol beverage mix', 'description': 'Cocoa Flavanol beverage mix (flavanols, 566mg; caffeine, 11mg \\& theobromine, 93mg)', 'interventionNames': ['Dietary Supplement: Cocoa Flavanol beverage mix']}, {'type': 'EXPERIMENTAL', 'label': 'De-xanthinated Cocoa Flavanol beverage mix', 'description': 'De-xanthinated Cocoa Flavanol beverage mix (flavanols, 583mg; caffeine, 0.6mg \\& theobromine, 0.2mg)', 'interventionNames': ['Dietary Supplement: De-xanthinated Cocoa Flavanol beverage mix']}], 'interventions': [{'name': 'Cocoa Flavanol beverage mix', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Acute consumption of single portion of cocoa powder dissolved in 310g 1% milk.', 'armGroupLabels': ['Cocoa Flavanol beverage mix']}, {'name': 'De-xanthinated Cocoa Flavanol beverage mix', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Acute consumption of single portion of cocoa powder dissolved in 310g 1% milk.', 'armGroupLabels': ['De-xanthinated Cocoa Flavanol beverage mix']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BT52 1SA', 'city': 'Coleraine', 'state': 'Co.Londonderry', 'country': 'United Kingdom', 'facility': 'Human Intervention Studies Unit, Ulster University', 'geoPoint': {'lat': 55.13333, 'lon': -6.66667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulster', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, Davis', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}