Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
Study NCT ID:
NCT03452605
Status:
COMPLETED
Last Update Posted:
2018-03-02
First Post:
2018-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Cocoa Flavanol on the BOLD Response and Cognitive Function in Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-01', 'studyFirstSubmitDate': '2018-02-23', 'studyFirstSubmitQcDate': '2018-03-01', 'lastUpdatePostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cognitive function', 'timeFrame': '5 min', 'description': 'reaction time (milliseconds) on the flanker task'}, {'measure': 'BOLD fmri response', 'timeFrame': '5 min', 'description': 'blood oxygenation level dependent response during flanker test'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Type 1 Diabetes (T1D) is associated with microvascular changes in the brain, which can cause cognitive dysfunction. Cocoa flavanols (CF) can stimulate vasodilation, resulting in enhanced cerebral blood flow and better cognitive function. This study aimed to investigate whether acute CF supplementation can improve cognitive function and the hemodynamic (BOLD) response in T1D patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non-smoking T1D patients or matched healthy controls\n* having diabetes for more than 1 year\n* males and females older than 18 years\n* stable medications for more than 6 months (no use of cholinesterase inhibitors or prior use of multivitamins was allowed)\n* adequate visual and auditory acuity to allow neuropsychological testing.\n\nExclusion Criteria:\n\n* participant enrolled in any investigational drug study within 2 months or longer, depending on the investigational drug half-life\n* history in the past 2 years of epileptic seizures or any major psychiatric disorder\n* history or MRI evidence of brain damage, including significant trauma, stroke, hydrocephalus, mental retardation, or serious neurological disorder,\n* significant history of alcoholism or drug abuse\n* unstable cardiac, renal, lung, liver, or other severe chronic disease\n* hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pres-sure ≥100 mmHg) or hypotension (systolic blood pressure \\<100 mmHg)\n* pacemaker or other medical metal devices that precludes performing MRI,\n* chronic inflammatory diseases, including lupus, rheumatoid arthritis, or polymyalgia rheumatic\n* macrovascular complications\n* retinopathy, nephropathy or neuropathy (microvascular complications)'}, 'identificationModule': {'nctId': 'NCT03452605', 'briefTitle': 'The Effect of Cocoa Flavanol on the BOLD Response and Cognitive Function in Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Vrije Universiteit Brussel'}, 'officialTitle': 'Effect of Acute Cocoa Flavanol Intake on the BOLD Response and Cognitive Function in Patients With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'T1DCFMRI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high cocoa flavanol drink', 'description': 'high cocoa flavanol drink (900 mg cocoa flavanol dissolved in 300 ml skimmed milk) 2h pre-fMRI', 'interventionNames': ['Dietary Supplement: cocoa flavanol supplementation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'low cocoa flavanol drink', 'description': 'low cocoa flavanol drink (30 mg cocoa flavanol dissolved in 300 ml skimmed milk), matched for theobromine, caffeine and macronutrients with the high cocoa flavanol drink 2h-pre fMRI', 'interventionNames': ['Dietary Supplement: cocoa flavanol supplementation']}], 'interventions': [{'name': 'cocoa flavanol supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'cocoa flavanols (containing 196 mg epicatechin)', 'armGroupLabels': ['high cocoa flavanol drink', 'low cocoa flavanol drink']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vrije Universiteit Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Romain Meeusen', 'investigatorAffiliation': 'Vrije Universiteit Brussel'}}}}