Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2026-02-19 @ 4:09 AM
Study NCT ID:
NCT03877003
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2019-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasma TMAO and Choline Levels in Individuals With Metabolic Syndrome - Comparison Between Eggs and Choline Supplement.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004531', 'term': 'Eggs'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D002794', 'term': 'Choline'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D009861', 'term': 'Onium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized crossover design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2019-03-13', 'studyFirstSubmitQcDate': '2019-03-13', 'lastUpdatePostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma choline and TMAO (micromol/L)', 'timeFrame': '1 year', 'description': 'They will be measured simultaneously by use of a mass spectrophotometer'}, {'measure': 'Plasma lipids (total cholesterol, HDL cholesterol and triglycerides) in mg/dL', 'timeFrame': '1 year', 'description': 'They will be measured simultaneoulsy by use of an automated spectrophotometer'}], 'secondaryOutcomes': [{'measure': 'Analysis of microbiota diversity (expressed as concentrations of different microorganisms.', 'timeFrame': '1 year', 'description': 'All microorganisms are assayed simultaneously'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eggs,', 'choline', 'metabolic syndrome', 'TMAO'], 'conditions': ['Coronary Artery Disease', 'Diabetes', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the effects of consuming either 3 eggs per day and compare it to daily choline supplement (choline bitartrate) for a dose of approximately 400 mg/day on plasma concentrations of high density lipoprotein cholesterol (HDL-c), trimethylamine N oxide (TMAO) and plasma choline. The goal is to determine if choline given as phosphatidyl choline (from eggs) will have a more beneficial effect on plasma choline and microbiota.', 'detailedDescription': 'Epidemiological data suggests that egg intake does not increase the risk for cardiovascular disease (CVD). In fact eggs are a good source of phosphatidyl choline (PC) and choline has a number of metabolic roles including lipid metabolism, membrane structure, liver health and a neurotransmitter. Recent reports that choline may be metabolized by the intestinal microbiota into TMAO, a compound that may increase the risk for heart disease. It is not clear how much egg contribute to TMAO formation in individuals with metabolic syndrome.\n\nTherefore the objective of this study is to determine the impact of daily intake of 3 eggs versus a choline supplement on plasma TMAO and other biomarkers for CVD risk and also to assess if there are changes in microbiota with these interventions that might lead to the increases of TMAO in plasma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All genders\n* 35-70 years\n* Metabolic syndrome (based on 3 out of 5 characteristics: waist circumference \\> 88 cm for women and \\> 102 cm for men, plasma triglycerides \\> 150 mg/dL, fasting glucose \\> 100 mg/dL, blood pressure \\> 135/85 and HDL \\< 40 mg/dL for men and \\< 50 mg/dL for women),\n* willing to consume 3 eggs per day for 4 weeks\n* willing to consume choline supplement (400 mg/day for 4 weeks)\n\nExclusion Criteria:\n\n* Self-reported diaberes, cardiovascular disease, history of stroke, liver disease or cancer\n* Taking glucose lowering medications\n* Taking antibiotics in the previous 1 month\n* Triglycerides \\> 500 mg/dL,\n* Cholesterol \\> 240 mg/dL,\n* blood pressure \\> 145/100 mm of Hg\n* Allergic to eggs or to choline'}, 'identificationModule': {'nctId': 'NCT03877003', 'briefTitle': 'Plasma TMAO and Choline Levels in Individuals With Metabolic Syndrome - Comparison Between Eggs and Choline Supplement.', 'organization': {'class': 'OTHER', 'fullName': 'University of Connecticut'}, 'officialTitle': 'Plasma TMAO and Choline Levels in Individuals With Metabolic Syndrome - Comparison Between Eggs and Choline Supplement Intake', 'orgStudyIdInfo': {'id': 'H18-126'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Egg Intake', 'description': 'Consumption of 3 eggs per day for breakfast during 4 weeks', 'interventionNames': ['Other: Eggs']}, {'type': 'EXPERIMENTAL', 'label': 'Choline Supplement Intake', 'description': 'Consumption of choline supplement 1.5 tablets (approx. 400 mg) with breakfast for 4 weeks', 'interventionNames': ['Other: Eggs']}], 'interventions': [{'name': 'Eggs', 'type': 'OTHER', 'otherNames': ['Dietary supplement (choline bitartrate)'], 'description': 'Eggs: Consume 3 eggs per day for 4 weeks Choline supplement: Consume 1.5 pills per day for 4 weeks', 'armGroupLabels': ['Choline Supplement Intake', 'Egg Intake']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06269', 'city': 'Storrs', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Department of Nutritional Sciences', 'geoPoint': {'lat': 41.80843, 'lon': -72.24952}}, {'zip': '06269', 'city': 'Storrs', 'state': 'Connecticut', 'country': 'United States', 'facility': 'University of Connecticut', 'geoPoint': {'lat': 41.80843, 'lon': -72.24952}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Connecticut', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Egg Board', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Maria Luz Fernandez', 'investigatorAffiliation': 'University of Connecticut'}}}}