Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-02-22 @ 4:14 AM
Study NCT ID:
NCT02692235
Status:
COMPLETED
Last Update Posted:
2019-05-23
First Post:
2016-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Carnitine Supplementation and Skeletal Muscle Function
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002331', 'term': 'Carnitine'}], 'ancestors': [{'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'robol@awf.gda.pl', 'phone': '+48 58 5547392', 'title': 'Robert Olek', 'organization': 'AWFiS'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Carnitine', 'description': '24 weeks l-carnitine-l-tartrate supplementation\n\ncarnitine: 1500 mg/d l-carnitine-l-tartrate', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 1, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': '24 weeks isonitrogenous supplementation\n\nplacebo: isonitrogenous', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 2, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'acid reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'headache and dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Blood Inflammatory Marker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carnitine', 'description': '24 weeks l-carnitine-l-tartrate supplementation\n\ncarnitine: 1500 mg/d l-carnitine-l-tartrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': '24 weeks isonitrogenous supplementation\n\nplacebo: isonitrogenous'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '2.6', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'after 24 weeks', 'categories': [{'measurements': [{'value': '2.9', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and after 24 weeks of supplementation period', 'description': 'Serum C-reactive protein concentration determined by the enzyme immunoassay method using commercially available kit (Cloud-Clone Corp., Houston, USA)', 'unitOfMeasure': 'mg·L^-1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 male and 1 smoking female subjects excluded from the \\*Placebo\\* statistical analyses for group homogeneity'}, {'type': 'SECONDARY', 'title': 'Lipid Metabolites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carnitine', 'description': '24 weeks l-carnitine-l-tartrate supplementation\n\ncarnitine: 1500 mg/d l-carnitine-l-tartrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': '24 weeks isonitrogenous supplementation\n\nplacebo: isonitrogenous'}], 'classes': [{'title': 'TCh baseline', 'categories': [{'measurements': [{'value': '233', 'spread': '13', 'groupId': 'OG000'}, {'value': '221', 'spread': '13', 'groupId': 'OG001'}]}]}, {'title': 'TCh after 24 weeks', 'categories': [{'measurements': [{'value': '221', 'spread': '14', 'groupId': 'OG000'}, {'value': '196', 'spread': '14', 'groupId': 'OG001'}]}]}, {'title': 'HDL baseline', 'categories': [{'measurements': [{'value': '69', 'spread': '5', 'groupId': 'OG000'}, {'value': '68', 'spread': '6', 'groupId': 'OG001'}]}]}, {'title': 'HDL after 24 weeks', 'categories': [{'measurements': [{'value': '69', 'spread': '5', 'groupId': 'OG000'}, {'value': '61', 'spread': '3', 'groupId': 'OG001'}]}]}, {'title': 'LDL baseline', 'categories': [{'measurements': [{'value': '140', 'spread': '11', 'groupId': 'OG000'}, {'value': '130', 'spread': '11', 'groupId': 'OG001'}]}]}, {'title': 'LDL after 24 weeks', 'categories': [{'measurements': [{'value': '131', 'spread': '11', 'groupId': 'OG000'}, {'value': '115', 'spread': '13', 'groupId': 'OG001'}]}]}, {'title': 'TG baseline', 'categories': [{'measurements': [{'value': '116', 'spread': '10', 'groupId': 'OG000'}, {'value': '117', 'spread': '22', 'groupId': 'OG001'}]}]}, {'title': 'TG after 24 weeks', 'categories': [{'measurements': [{'value': '105', 'spread': '16', 'groupId': 'OG000'}, {'value': '98', 'spread': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and after 24 weeks of supplementation period', 'description': 'Change in serum lipid metabolites: total cholesterol (TCh), HDL-cholesterol (HDL), LDL-cholesterol (LDL), triglycerides (TG) determined by standard automatic analyzer Cobas 6000 (Roche Diagnostics, Mannheim, Germany)', 'unitOfMeasure': 'mg·dL^-1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 male and 1 smoking female subjects excluded from the \\*Placebo\\* statistical analyses for group homogeneity'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Carnitine', 'description': '24 weeks l-carnitine-l-tartrate supplementation\n\ncarnitine: 1500 mg/d l-carnitine-l-tartrate'}, {'id': 'FG001', 'title': 'Placebo', 'description': '24 weeks isonitrogenous supplementation\n\nplacebo: isonitrogenous'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '42 subjects volunteered to participate in the study. After the initial screening, 28 were included in the study (14 subject not meeting inclusion criteria) and were randomly assigned to either an L-carnitine (n=14) or a placebo supplementation group (n=14).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Carnitine', 'description': '24 weeks l-carnitine-l-tartrate supplementation\n\ncarnitine: 1500 mg/d l-carnitine-l-tartrate'}, {'id': 'BG001', 'title': 'Placebo', 'description': '24 weeks isonitrogenous supplementation\n\nplacebo: isonitrogenous'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '28.2', 'spread': '4.5', 'groupId': 'BG000'}, {'value': '28.0', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '28.1', 'spread': '5.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-28', 'size': 211353, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-02-28T06:08', 'hasProtocol': False}, {'date': '2015-06-22', 'size': 383187, 'label': 'Study Protocol and Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'Prot_ICF_001.pdf', 'typeAbbrev': 'Prot_ICF', 'uploadDate': '2018-02-28T06:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-09', 'studyFirstSubmitDate': '2016-02-13', 'resultsFirstSubmitDate': '2017-07-17', 'studyFirstSubmitQcDate': '2016-02-22', 'lastUpdatePostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-07', 'studyFirstPostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Inflammatory Marker', 'timeFrame': 'baseline and after 24 weeks of supplementation period', 'description': 'Serum C-reactive protein concentration determined by the enzyme immunoassay method using commercially available kit (Cloud-Clone Corp., Houston, USA)'}], 'secondaryOutcomes': [{'measure': 'Lipid Metabolites', 'timeFrame': 'baseline and after 24 weeks of supplementation period', 'description': 'Change in serum lipid metabolites: total cholesterol (TCh), HDL-cholesterol (HDL), LDL-cholesterol (LDL), triglycerides (TG) determined by standard automatic analyzer Cobas 6000 (Roche Diagnostics, Mannheim, Germany)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['carnitine'], 'conditions': ['Sarcopenia']}, 'descriptionModule': {'briefSummary': 'Research project objectives The primary aim of the current research project is to use carnitine supplementation as the anti-inflammatory intervention for exploring the relationship between inflammation and associated with aging reduction of skeletal muscle mass.\n\nHypothesis The carnitine supplementation modulates the blood cytokines concentration. Anti-inflammatory intervention delay the reduction of skeletal muscle mass associated with aging', 'detailedDescription': 'Volunteers over 65 years old (n=40) are supplemented either with carnitine or placebo for 24 weeks. Before the start, in the mid-point, and after finishing the supplementation the following primary outputs variables are performed: body composition analysis (InBody720), maximal isokinetic knee extensor peak torque (Biodex System 4 Pro), blood cytokines and carnitine concentration, blood lipid profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with no history of gastrointestinal disorders, cardiovascular disease or hypertension.\n\nExclusion Criteria:\n\n* Subjects having any illnesses and a history of gastrointestinal disorder, cardiovascular disease, hypertension, liver and renal disease, diabetes, cancer, alcoholism or other metabolic diseases.'}, 'identificationModule': {'nctId': 'NCT02692235', 'briefTitle': 'Carnitine Supplementation and Skeletal Muscle Function', 'organization': {'class': 'OTHER', 'fullName': 'Gdansk University of Physical Education and Sport'}, 'officialTitle': 'Carnitine Supplementation and Skeletal Muscle Function in Aging', 'orgStudyIdInfo': {'id': '2014/15/B/NZ7/00893'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'carnitine', 'description': '24 weeks l-carnitine-l-tartrate supplementation', 'interventionNames': ['Dietary Supplement: carnitine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': '24 weeks isonitrogenous supplementation', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'carnitine', 'type': 'DIETARY_SUPPLEMENT', 'description': '1500 mg/d l-carnitine-l-tartrate', 'armGroupLabels': ['carnitine']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'isonitrogenous', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80-336', 'city': 'Gdansk', 'state': 'Pomeranian Voivodeship', 'country': 'Poland', 'facility': 'University of Physical Education and Sport', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}], 'overallOfficials': [{'name': 'Robert A Olek, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gdansk University of Physical Education and Sport'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gdansk University of Physical Education and Sport', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Science Centre, Poland', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Robert Olek', 'investigatorAffiliation': 'Gdansk University of Physical Education and Sport'}}}}