Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2026-02-09 @ 10:56 PM
Study NCT ID:
NCT04255368
Status:
COMPLETED
Last Update Posted:
2020-11-04
First Post:
2020-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Choline Source, Gut Microbiota and Trimethylamine-N-oxide Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, controlled crossover design where participants consume 3 meals containing (i) free choline; (ii) phosphatidylcholine; or (iii) no choline in a random order separated by a 1-week washout period'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-03', 'studyFirstSubmitDate': '2020-01-22', 'studyFirstSubmitQcDate': '2020-02-03', 'lastUpdatePostDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TMAO metabolite concentration change', 'timeFrame': 'Blood: study baseline, 30 minutes and 1 hour, 2 hours, 4 hours and 6 hours', 'description': 'Plasma TMAO metabolite response'}, {'measure': 'TMAO metabolite concentration change', 'timeFrame': 'Urine: study baseline, pooled 6 hours study period', 'description': 'Urinary TMAO metabolite response'}, {'measure': 'Gut microbiome profile', 'timeFrame': 'Stool: one-time baseline', 'description': '16S rRNA'}], 'secondaryOutcomes': [{'measure': 'One-carbon metabolite concentration change', 'timeFrame': 'Blood: study baseline, 30 minutes and 1 hour, 2 hours, 4 hours and 6 hours', 'description': 'Plasma choline metabolite response'}, {'measure': 'Phosphatidylcholine concentration change', 'timeFrame': 'Blood: study baseline, 30 minutes and 1 hour, 2 hours, 4 hours and 6 hours', 'description': 'Plasma phosphatidylcholine response'}, {'measure': 'One-carbon metabolite concentration change', 'timeFrame': 'Urine: study baseline, pooled 6 hours study period', 'description': 'Urinary choline metabolite response'}, {'measure': 'Inflammation and cardiovascular disease risk marker concentration change', 'timeFrame': 'Blood: study baseline to 6 hours', 'description': 'Plasma TNF-α and IL-6'}, {'measure': 'Flavin monooxygenase 3 (FMO3) 472 G>A genotype variant', 'timeFrame': 'Blood: study baseline', 'description': 'Genetic polymorphism'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dietary precursor', 'Metabolism', 'Gut microbiota'], 'conditions': ['Metabolism']}, 'referencesModule': {'references': [{'pmid': '23614584', 'type': 'BACKGROUND', 'citation': 'Tang WH, Wang Z, Levison BS, Koeth RA, Britt EB, Fu X, Wu Y, Hazen SL. Intestinal microbial metabolism of phosphatidylcholine and cardiovascular risk. N Engl J Med. 2013 Apr 25;368(17):1575-84. doi: 10.1056/NEJMoa1109400.'}, {'pmid': '21475195', 'type': 'BACKGROUND', 'citation': 'Wang Z, Klipfell E, Bennett BJ, Koeth R, Levison BS, Dugar B, Feldstein AE, Britt EB, Fu X, Chung YM, Wu Y, Schauer P, Smith JD, Allayee H, Tang WH, DiDonato JA, Lusis AJ, Hazen SL. Gut flora metabolism of phosphatidylcholine promotes cardiovascular disease. Nature. 2011 Apr 7;472(7341):57-63. doi: 10.1038/nature09922.'}, {'pmid': '27377678', 'type': 'BACKGROUND', 'citation': 'Cho CE, Taesuwan S, Malysheva OV, Bender E, Tulchinsky NF, Yan J, Sutter JL, Caudill MA. Trimethylamine-N-oxide (TMAO) response to animal source foods varies among healthy young men and is influenced by their gut microbiota composition: A randomized controlled trial. Mol Nutr Food Res. 2017 Jan;61(1). doi: 10.1002/mnfr.201600324. Epub 2016 Aug 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to determine the production of trimethylamine-N-oxide (TMAO) from different forms of choline and whether this response is modified by the gut microbiota composition.', 'detailedDescription': 'The overall goal of this research is to identify dietary and physiological factors contributing to elevated levels of trimethylamine-N-oxide (TMAO), a choline-derived gut-microbiome-dependent metabolite that has been identified to increase cardiovascular disease risk. Our recent findings indicate that the gut microbiome may account for variations in TMAO levels, whereby those with a greater enrichment of Firmicutes to Bacteroidetes had elevated TMAO response to dietary precursor intake. However, the interaction between choline intake and gut microbiota composition as a determinant of interindividual variations in TMAO response has not been investigated. This study sought to i) compare plasma and urinary TMAO response after acute challenge containing different forms of choline; and ii) to determine the association between differences in TMAO response with differences in gut microbiota composition. To accomplish these objectives, a randomized, controlled cross-over study was conducted in healthy participants (n=41). The study incorporated three arms comprised of study meals containing (i) 600 mg choline as choline bitartrate; (ii) 600 mg choline as phosphatidylcholine; or (iii) no choline. Each meal was served with a bagel with margarine-butter spread and one cup of water, administered in a single day and separated by a 1-week washout period. Baseline blood sample was obtained by a phlebotomist using a standard venipuncture procedure, and participants collected their baseline urine sample. They also turned in a one-time self-collected baseline stool sample. Following the consumption of the study meal, serial blood samples were collected at 30 min and 1, 2, 4 and 6 h, and urine samples collected throughout the 6 h study period. At 4.5 h, participants were provided a fixed fruit snack (i.e., 2 single serving prepackaged applesauce) and water.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women of any race or ethnicity\n* Age 21-50 y\n* BMI 20-24.9 kg/m2 or BMI 30-39.9 kg/m2\n\nExclusion Criteria:\n\n* Age \\> 50 y\n* BMI outside of the normal-weight or obese range (BMI \\< 20 kg/m2; BMI 25-29.9 kg/m2; or BMI \\> or = 40 kg/m2)\n* Pregnant or planning to become pregnant during the course of the study; currently breastfeeding (females)\n* Vegetarians\n* Smokers or recreational drug users\n* Individuals with gastrointestinal diseases or complaints, chronic illnesses or other metabolic diseases (including trimethylaminuria)\n* Individuals who have taken antibiotics within the past 2 months\n* Individuals who are not willing to discontinue pre- and probiotics and dietary supplements for the time leading up to 2 months before the study and during the study'}, 'identificationModule': {'nctId': 'NCT04255368', 'briefTitle': 'Choline Source, Gut Microbiota and Trimethylamine-N-oxide Response', 'organization': {'class': 'OTHER', 'fullName': 'Utah State University'}, 'officialTitle': 'Effect of Choline Source and Gut Microbiota Composition on Trimethylamine-N-oxide Response in Humans', 'orgStudyIdInfo': {'id': '8547'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Water-soluble choline', 'description': 'A breakfast meal consisting of 1 cup of tomato soup containing 600 mg choline as choline bitartrate; served with a bagel with margarine-butter spread and one cup of water.', 'interventionNames': ['Other: Water-soluble choline']}, {'type': 'EXPERIMENTAL', 'label': 'Fat-soluble choline', 'description': 'A breakfast meal consisting of 1 cup of tomato soup containing 600 mg choline as phosphatidylcholine; served with a bagel with margarine-butter spread and one cup of water.', 'interventionNames': ['Other: Fat-soluble choline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'No choline', 'description': 'A breakfast meal consisting of 1 cup of tomato soup containing no choline; served with a bagel with margarine-butter spread and one cup of water.', 'interventionNames': ['Other: No choline control']}], 'interventions': [{'name': 'Water-soluble choline', 'type': 'OTHER', 'description': '600 mg choline as choline bitartrate', 'armGroupLabels': ['Water-soluble choline']}, {'name': 'Fat-soluble choline', 'type': 'OTHER', 'description': '600 mg choline as phosphatidylcholine', 'armGroupLabels': ['Fat-soluble choline']}, {'name': 'No choline control', 'type': 'OTHER', 'description': 'No choline', 'armGroupLabels': ['No choline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84322', 'city': 'Logan', 'state': 'Utah', 'country': 'United States', 'facility': 'Center for Human Nutrition Studies Clinic, Utah State University', 'geoPoint': {'lat': 41.73549, 'lon': -111.83439}}], 'overallOfficials': [{'name': 'Clara E Cho, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Utah State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Utah State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}