Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-05 @ 2:05 PM
Study NCT ID:
NCT01494051
Status:
COMPLETED
Last Update Posted:
2020-04-29
First Post:
2011-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
High Protein Diet in Patients With Long-chain Fatty Acid Oxidation Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536353', 'term': 'VLCAD deficiency'}, {'id': 'C566945', 'term': 'Trifunctional Protein Deficiency With Myopathy And Neuropathy'}, {'id': 'C535589', 'term': 'Carnitine palmitoyl transferase 2 deficiency'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018752', 'term': 'Diet, Fat-Restricted'}, {'id': 'D000076107', 'term': 'Diet, High-Protein Low-Carbohydrate'}, {'id': 'D000073600', 'term': 'Diet, High-Protein'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gillingm@ohsu.edu', 'phone': '503-494-1682', 'title': 'Dr. Melanie Gillingham', 'organization': 'Oregon Health & Science University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'High Carbohydrate Diet', 'description': 'Diet composition of 10% long-chain fatty acids, 20% medium-chain triglycerides, 12% protein and 68% carbohydrate is the current standard of care in long-chain fatty acid oxidation disorders.\n\nDiet counseling: Subjects counseled how to follow either the high carbohydrate diet or the high protein diet for 4 months at home.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'High Protein Diet', 'description': 'Diet composition of 10% long-chain fatty acids, 20% medium chain triglycerides, 25% protein and 45% carbohydrate is the comparison diet. Fat content is the same between treatments; only the carbohydrate to protein ratio varies.\n\nDiet counseling: Subjects counseled how to follow either the high carbohydrate diet or the high protein diet for 4 months at home.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Energy Expenditure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Carbohydrate Diet', 'description': 'Diet composition of 10% long-chain fatty acids, 20% medium-chain triglycerides, 12% protein and 68% carbohydrate is the current standard of care in long-chain fatty acid oxidation disorders.\n\nDiet counseling: Subjects counseled how to follow either the high carbohydrate diet or the high protein diet for 4 months at home.'}, {'id': 'OG001', 'title': 'High Protein Diet', 'description': 'Diet composition of 10% long-chain fatty acids, 20% medium chain triglycerides, 25% protein and 45% carbohydrate is the comparison diet. Fat content is the same between treatments; only the carbohydrate to protein ratio varies.\n\nDiet counseling: Subjects counseled how to follow either the high carbohydrate diet or the high protein diet for 4 months at home.'}], 'classes': [{'categories': [{'measurements': [{'value': '2045', 'spread': '273', 'groupId': 'OG000'}, {'value': '2343', 'spread': '507', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'change from baseline after 4 months of treatment', 'description': 'does energy expenditure and substrate oxidation differ between subjects randomized to the high carbohydrate versus the high protein diet? We measured resting energy expenditure with indirect calorimetry and estimated substrate oxidation with indirect calorimetry results and urine urea nitrogen excretion. We also measured total energy expenditure with doubly labeled water.', 'unitOfMeasure': 'kcal', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Body Composition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Carbohydrate Diet', 'description': 'Diet composition of 10% long-chain fatty acids, 20% medium-chain triglycerides, 12% protein and 68% carbohydrate is the current standard of care in long-chain fatty acid oxidation disorders.\n\nDiet counseling: Subjects counseled how to follow either the high carbohydrate diet or the high protein diet for 4 months at home.'}, {'id': 'OG001', 'title': 'High Protein Diet', 'description': 'Diet composition of 10% long-chain fatty acids, 20% medium chain triglycerides, 25% protein and 45% carbohydrate is the comparison diet. Fat content is the same between treatments; only the carbohydrate to protein ratio varies.\n\nDiet counseling: Subjects counseled how to follow either the high carbohydrate diet or the high protein diet for 4 months at home.'}], 'classes': [{'title': 'Lean Mass', 'categories': [{'measurements': [{'value': '-0.75', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '1.17', 'groupId': 'OG001'}]}]}, {'title': 'Fat Mass', 'categories': [{'measurements': [{'value': '0.51', 'spread': '4.34', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'change from baseline to 4 months of treatment', 'description': 'does body composition change more among subjects randomized to the high protein diet compared to the high carbohydrate diet? We measured body composition at baseline and again at the end of the study by DEXA - dual energy x-ray absorptiometry.', 'unitOfMeasure': 'change in kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Carbohydrate Diet', 'description': 'Diet composition of 10% long-chain fatty acids, 20% medium-chain triglycerides, 12% protein and 68% carbohydrate is the current standard of care in long-chain fatty acid oxidation disorders.\n\nDiet counseling: Subjects counseled how to follow either the high carbohydrate diet or the high protein diet for 4 months at home.'}, {'id': 'FG001', 'title': 'High Protein Diet', 'description': 'Diet composition of 10% long-chain fatty acids, 20% medium chain triglycerides, 25% protein and 45% carbohydrate is the comparison diet. Fat content is the same between treatments; only the carbohydrate to protein ratio varies.\n\nDiet counseling: Subjects counseled how to follow either the high carbohydrate diet or the high protein diet for 4 months at home.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'High Carbohydrate Diet', 'description': 'Diet composition of 10% long-chain fatty acids, 20% medium-chain triglycerides, 12% protein and 68% carbohydrate is the current standard of care in long-chain fatty acid oxidation disorders.\n\nDiet counseling: Subjects counseled how to follow either the high carbohydrate diet or the high protein diet for 4 months at home.'}, {'id': 'BG001', 'title': 'High Protein Diet', 'description': 'Diet composition of 10% long-chain fatty acids, 20% medium chain triglycerides, 25% protein and 45% carbohydrate is the comparison diet. Fat content is the same between treatments; only the carbohydrate to protein ratio varies.\n\nDiet counseling: Subjects counseled how to follow either the high carbohydrate diet or the high protein diet for 4 months at home.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14', 'spread': '5', 'groupId': 'BG000'}, {'value': '17', 'spread': '10', 'groupId': 'BG001'}, {'value': '16', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'North America', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-20', 'studyFirstSubmitDate': '2011-12-14', 'resultsFirstSubmitDate': '2020-04-07', 'studyFirstSubmitQcDate': '2011-12-15', 'lastUpdatePostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-07', 'studyFirstPostDateStruct': {'date': '2011-12-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Energy Expenditure', 'timeFrame': 'change from baseline after 4 months of treatment', 'description': 'does energy expenditure and substrate oxidation differ between subjects randomized to the high carbohydrate versus the high protein diet? We measured resting energy expenditure with indirect calorimetry and estimated substrate oxidation with indirect calorimetry results and urine urea nitrogen excretion. We also measured total energy expenditure with doubly labeled water.'}], 'secondaryOutcomes': [{'measure': 'Body Composition', 'timeFrame': 'change from baseline to 4 months of treatment', 'description': 'does body composition change more among subjects randomized to the high protein diet compared to the high carbohydrate diet? We measured body composition at baseline and again at the end of the study by DEXA - dual energy x-ray absorptiometry.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fatty acid oxidation disorders'], 'conditions': ['Very Long-chain Acyl-CoA Dehydrogenase Deficiency', 'Trifunctional Protein Deficiency', 'Carnitine Palmitoyltransferase 2 Deficiency', 'Long-chain 3-hydroxyacyl-CoA Dehydrogenase Deficiency']}, 'descriptionModule': {'briefSummary': 'The study also determines if eating a diet higher in protein alters body composition, energy balance and metabolic control among patients with a long-chain fatty acid oxidation disorder.', 'detailedDescription': 'At baseline, the amount of muscle and fat in the whole body and inside the liver and muscle will be measured. All subjects will complete a moderate treadmill exercise test and a test to determine how they use sugar (oral glucose tolerance test). The amount and type of energy burned by each subject will be measured. Subjects will be randomly assigned to follow either a high carbohydrate diet or a reduced carbohydrate, high protein diet for 4 months. At the end of 4 months, the tests will be repeated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of a long-chain fatty acid oxidation disorder including VLCAD, CPT2, LCHAD or TFP deficiency\n* 7 years old or greater\n* able to comply with diet guidelines\n\nExclusion Criteria:\n\n* pregnant\n* enrolled in another study that alters diet composition\n* cannot complete treadmill exercise study'}, 'identificationModule': {'nctId': 'NCT01494051', 'briefTitle': 'High Protein Diet in Patients With Long-chain Fatty Acid Oxidation Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Fatty Acid Oxidation and Body Weight Regulation in Long-chain Fatty Acid Oxidation Disorders.', 'orgStudyIdInfo': {'id': 'DK71869-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High carbohydrate diet', 'description': 'Diet composition of 10% long-chain fatty acids, 20% medium-chain triglycerides, 12% protein and 68% carbohydrate is the current standard of care in long-chain fatty acid oxidation disorders.', 'interventionNames': ['Behavioral: Diet counseling']}, {'type': 'EXPERIMENTAL', 'label': 'High protein diet', 'description': 'Diet composition of 10% long-chain fatty acids, 20% medium chain triglycerides, 25% protein and 45% carbohydrate is the comparison diet. Fat content is the same between treatments; only the carbohydrate to protein ratio varies.', 'interventionNames': ['Behavioral: Diet counseling']}], 'interventions': [{'name': 'Diet counseling', 'type': 'BEHAVIORAL', 'otherNames': ['low fat diet', 'high carbohydrate diet', 'high protein diet'], 'description': 'Subjects counseled how to follow either the high carbohydrate diet or the high protein diet for 4 months at home.', 'armGroupLabels': ['High carbohydrate diet', 'High protein diet']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Melanie B Gillingham', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}