Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-01-01 @ 10:37 PM
Study NCT ID:
NCT06623032
Status:
RECRUITING
Last Update Posted:
2024-12-09
First Post:
2024-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Effects of Medium-Chain Fatty Acids in Patients with Medium-Chain Acyl-CoA Dehydrogenase Deficiency and Healthy Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536038', 'term': 'Medium chain acyl CoA dehydrogenase deficiency'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2024-09-23', 'studyFirstSubmitQcDate': '2024-09-29', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ketone Bodies', 'timeFrame': 'During both individual test days', 'description': 'To measure the effect of Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) on circulating ketone body concentrations.'}], 'secondaryOutcomes': [{'measure': 'Resting metabolic rate', 'timeFrame': 'During both individual test days', 'description': 'To measure the effect of Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) on resting metabolic rate.'}, {'measure': 'Respiratory exchange ratio', 'timeFrame': 'During both individual test days', 'description': 'To measure the effect of Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) on respiratory exchange ratio.'}, {'measure': 'Vasodilator Function', 'timeFrame': 'During both individual test days', 'description': 'To measure the effect of Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) on vasodilator function.'}, {'measure': 'Fatty Acid Composition', 'timeFrame': 'During both individual test days', 'description': 'To measure the effect of Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) on fatty acid composition.'}, {'measure': 'Metabolites', 'timeFrame': 'During both individual test days', 'description': 'To measure the effect of Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) on circulating ketone body concentrations.'}, {'measure': 'Hepatokines', 'timeFrame': 'During both individual test days', 'description': 'To measure the effect of Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) on circulating hepatokine concentrations.'}, {'measure': 'Beta cell function', 'timeFrame': 'During both individual test days', 'description': 'To measure the effect of Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) on Beta cell function.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MCADD', 'Lipid metabolism', 'Ketone bodies', 'Medium-Chain Fatty Acid (MCFA)', 'Long-Chain Fatty Acid (LCFA)'], 'conditions': ['Medium-chain Acyl-CoA Dehydrogenase Deficiency']}, 'descriptionModule': {'briefSummary': 'The aim of this project is to investigate the physiological effects of intake of long-chain fatty acids (LCFA) and medium-chain fatty acids (MCFA) in patients with Medium-Chain Acyl-CoA Dehydrogenase Deficiency (MCADD) and healthy individuals', 'detailedDescription': 'Male and female MCADD patients and healthy individuals will be included in this study which is a randomized intervention study in a cross over design consisting of two separate test days.\n\nThe study involves two test days of four hours each, during which the participants ingests either medium-chain fatty acids (MCFA) or long-chain fatty acids (LCFA) in the form of triacylglycerol oils. The order of fatty acid oils ingested is determined by randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria MCADD patients:\n\n* Male or female\n* Age between 18-80 years old\n* Diagnosed Medium-chain acyl-CoA dehydrogenase deficiency (MCADD\n\nInclusion Criteria Healthy Participants:\n\n* Male or female\n* Age between 18-80 years old\n\nExclusion Criteria both MCADD patients and healthy participants:\n\n* Diabetes\n* Kidney- or liver disease\n* Use of beta blockers or diuretics\n* Pregnant, lactating or planning to become pregnant within the study period\n* Regular intake of substantial amounts of coconut oil, palm kernel oil or any other source abundant in MCFA\n* Ongoing cancer treatment\n* Metabolic or absorptive disorders, gastric bypass operation, or use of medication affecting metabolism or food absorption\n* Inability, physically or mentally, to comply with the procedure required by the study protocol as evaluated by the primary investigator, study manager or clinical responsible'}, 'identificationModule': {'nctId': 'NCT06623032', 'acronym': 'MEMCADD', 'briefTitle': 'Metabolic Effects of Medium-Chain Fatty Acids in Patients with Medium-Chain Acyl-CoA Dehydrogenase Deficiency and Healthy Individuals', 'organization': {'class': 'OTHER', 'fullName': 'University of Copenhagen'}, 'officialTitle': 'Metabolic Effects of Medium-Chain Fatty Acids in Patients with Medium-Chain Acyl-CoA Dehydrogenase Deficiency and Healthy Individuals', 'orgStudyIdInfo': {'id': 'H-24044278'}, 'secondaryIdInfos': [{'id': 'NNF22OC0074110', 'type': 'OTHER_GRANT', 'domain': 'Novo Nordisk Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Participants', 'interventionNames': ['Other: Medium-Chain Fatty Acid (MCFA)', 'Other: Long-Chain Fatty Acid (LCFA)']}, {'type': 'EXPERIMENTAL', 'label': 'MCADD Patients', 'interventionNames': ['Other: Medium-Chain Fatty Acid (MCFA)', 'Other: Long-Chain Fatty Acid (LCFA)']}], 'interventions': [{'name': 'Medium-Chain Fatty Acid (MCFA)', 'type': 'OTHER', 'description': 'The participants will consume Medium-Chain Fatty Acid (MCFA) followed by Long-Chain Fatty Acid (LCFA)', 'armGroupLabels': ['Healthy Participants', 'MCADD Patients']}, {'name': 'Long-Chain Fatty Acid (LCFA)', 'type': 'OTHER', 'description': 'The participants will consume Long-Chain Fatty Acid (LCFA) followed by Medium-Chain Fatty Acid (MCFA).', 'armGroupLabels': ['Healthy Participants', 'MCADD Patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Andreas M Fritzen, Associate Professor', 'role': 'CONTACT', 'email': 'amfritzen@sund.ku.dk', 'phone': '+45 42 63 33 59'}], 'facility': 'University of Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Kasper S Jørgensen, PhD student', 'role': 'CONTACT', 'email': 'kaspersuhr@sund.ku.dk', 'phone': '+4523473023'}, {'name': 'Andreas M Fritzen, Associate Professor', 'role': 'CONTACT', 'email': 'amfritzen@sund.ku.dk'}], 'overallOfficials': [{'name': 'Andreas M Fritzen, Associate Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Copenhagen Neuromuscular Center', 'class': 'UNKNOWN'}, {'name': 'Center of Inherited Metabolic Diseases, Copenhagen University Hospital Rigshospitalet', 'class': 'UNKNOWN'}, {'name': 'Section of Molecular Physiology, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Denmark', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Andreas Mæchel Fritzen', 'investigatorAffiliation': 'University of Copenhagen'}}}}