Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-01-18 @ 11:14 AM
Study NCT ID:
NCT02838732
Status:
COMPLETED
Last Update Posted:
2023-12-18
First Post:
2016-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation on the Effect of Carnitine Supplement on Gut Microbiota and TMAO Production Capacity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All participants received L-carnitine supplementation (500 mg per tablet per day, GNC) for one month. Oral carnitine challenge tests and fecal sampling were conducted both before and after the intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-18'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-10', 'studyFirstSubmitDate': '2016-07-08', 'studyFirstSubmitQcDate': '2016-07-17', 'lastUpdatePostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TMAO level', 'timeFrame': 'Before and 1 month after L-carnitine supplementation', 'description': 'plasma and urine TMAO concentrations of oral carnitine challenge test'}, {'measure': 'Compositional and functional alterations of gut microbiota', 'timeFrame': 'Before and 1 month after L-carnitine supplementation', 'description': 'The compositional and functional changes of gut microbiota will be evaluated by shotgun metagenome sequencing. Taxonomy will be calculated as relative abundance of species-level genome bins (SGBs) and specific bacteria genes will be quantified as Reads Per Kilobase per Million (RPKM).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gut microbiota', 'Trimethylamine N-oxide', 'L-carnitine supplementation', 'Oral carnitine challenge test'], 'conditions': ['Dietary Exposure']}, 'referencesModule': {'references': [{'pmid': '30377191', 'type': 'DERIVED', 'citation': 'Wu WK, Chen CC, Liu PY, Panyod S, Liao BY, Chen PC, Kao HL, Kuo HC, Kuo CH, Chiu THT, Chen RA, Chuang HL, Huang YT, Zou HB, Hsu CC, Chang TY, Lin CL, Ho CT, Yu HT, Sheen LY, Wu MS. Identification of TMAO-producer phenotype and host-diet-gut dysbiosis by carnitine challenge test in human and germ-free mice. Gut. 2019 Aug;68(8):1439-1449. doi: 10.1136/gutjnl-2018-317155. Epub 2018 Oct 30.'}]}, 'descriptionModule': {'briefSummary': 'In this project, the investigators aim to explore the impact of dietary L-carnitine supplementation on the TMAO production capacity of gut microbiota.', 'detailedDescription': 'Recent studies have established plasma trimethylamine N-oxide (TMAO) levels as a strong, independent risk factor for cardiovascular disease. TMAO is produced by the interaction between gut microflora and ingested L-carnitine from food. Research indicates that both plasma TMAO concentration and the TMAO production capacity of gut microbiota in vegetarians are significantly lower than in omnivores, likely due to the reduced L-carnitine intake in vegetarian diets. This study aims to explore the impact of L-carnitine supplementation on the TMAO production capacity of human gut microbiota and to identify TMAO-producing bacteria within the gut microflora. The study plans to recruit both omnivore and vegetarian volunteers to undergo a one-month L-carnitine supplementation, followed by an evaluation of changes in TMAO production using an oral L-carnitine challenge test, along with gut microbiota assessment. TMAO concentration will be measured using LC-MS/MS, and gut microbiome analysis will be conducted through shotgun metagenome sequencing. Bioinformatic analysis may reveal potential TMAO-producing bacteria. Understanding the changes in TMAO production and gut microbiota composition post-L-carnitine supplementation may enhance our knowledge of the interplay between L-carnitine supplements, TMAO, and gut microflora.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects aged 20 to 65 years old\n* no usage of antibiotics within one month\n* no use of carnitine supplement within one month\n\nExclusion Criteria:\n\n* having serious GI disorder\n* medical history of myasthenia gravis\n* history of diabetes,\n* history of hyperparathyroidism,\n* history of chronic kidney disease\n* history of epilepsy\n* history of severe anemia'}, 'identificationModule': {'nctId': 'NCT02838732', 'briefTitle': 'Investigation on the Effect of Carnitine Supplement on Gut Microbiota and TMAO Production Capacity', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Investigation on the Effect of Carnitine Supplement on Gut Microbiota and TMAO Production Capacity', 'orgStudyIdInfo': {'id': '201507055MINC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'L-carnitine supplementation', 'description': 'All participants received L-carnitine supplementation (500 mg per tablet per day, provided by GNC) for one month. Oral carnitine challenge tests and fecal sampling were conducted both before and after the intervention.', 'interventionNames': ['Dietary Supplement: L-carnitine supplementation (500 mg per tablet per day, purchased from GNC company)']}], 'interventions': [{'name': 'L-carnitine supplementation (500 mg per tablet per day, purchased from GNC company)', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['L-carnitine supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Ming-Shiang Wu, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}