Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-10 @ 2:43 PM
Study NCT ID:
NCT06660251
Status:
COMPLETED
Last Update Posted:
2024-10-28
First Post:
2024-10-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Meat and Egg on TMAO in Plasma and Urine in Subjects with and Metabolic Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'A randomized, crossover intervention with two active groups (subjects with and without MetS) using two test foods (egg and meat, with high content of TMAO precursors) was carried out.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-24', 'studyFirstSubmitDate': '2024-10-07', 'studyFirstSubmitQcDate': '2024-10-24', 'lastUpdatePostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TMAO and related metabolite concentrations (micromole per litre) in plasma', 'timeFrame': 'Metabolite concentrations in plasma samples collected before ingestion of test food and after ingestion at 30, 60, 120, 240, and 360 minutes are used for calculation the incremental area under the curve.', 'description': 'TMAO and related metabolites (trimethylamine, betaine, choline, L-carnitine, and acetyl-L-carnitine) were analyzed by UPLC-MRM-MS in plasma samples collected before ingestion of test food and after ingestion at 30, 60, 120, 240, and 360 minutes.'}, {'measure': 'TMAO and related metabolite concentrations (micromole per litre) in urine', 'timeFrame': 'Post-dose sample over a 6-hours period.', 'description': 'TMAO and related metabolites (trimethylamine, betaine, choline, L-carnitine, and acetyl-L-carnitine) were analyzed by UPLC-MRM-MS in a composite urine sample collected during 6 hours post-dose.'}], 'secondaryOutcomes': [{'measure': 'Gut microbiota composition', 'timeFrame': 'The day before the first intervention day.', 'description': 'Gut microbiota composition in a stool sample collected on the day before the first intervention was analyzed by a full 16S rRNA gene sequencing kit from Oxford Nanopore Technology.'}, {'measure': 'Blood glucose and glycated hemoglobin', 'timeFrame': 'At screening (before intervention).', 'description': 'Fasting blood glucose and glycated hemoglobin (millimoles per liter mmol/l) were analyzed at screening.'}, {'measure': 'Plasma lipid profile', 'timeFrame': 'At screening (before intervention).', 'description': 'Plasma cholesterol, plasma high-density lipoprotein cholesterol, plasma cholesterol, and plasma triglycerides concentrations (millimoles per liter mmol/l) were analyzed at screening.'}, {'measure': 'Body mass index (BMI)', 'timeFrame': 'At screening (before intervention).', 'description': 'Weight in kilograms and height in meters were measured at screening and used to calculate BMI in kilograms per square.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metabolic syndrome', 'TMAO', 'Gut microbiota', 'Egg and meat', 'Plasma', 'Urine'], 'conditions': ['Metabolic Syndrome X']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to investigate in subjects with and without metabolic syndrome how meals of choline- and carnitine-rich foods (eggs and meat) affect the trimethylamine-N-oxide (TMAO) concentration in blood and urine in relation to the gut microbiota composition.\n\nIn response to the subjects´ gut microbiota, the concentrations of TMAO in the plasma and urine of subjects with and without metabolic syndrome (MetS) after ingesting choline- and carnitine-rich foods will be compared.\n\nOn two occasions, participants will receive after overnight fasting meatballs (170 g) or three hard-boiled eggs. Blood will be collected before ingestion and over 6 hours after test food consumption.', 'detailedDescription': 'There is a growing interest in the role of the intestinal microbiota in the global metabolism of their host. Trimethylamine-N-oxide (TMAO), a metabolite linked to the gut microbiota, has recently emerged as a risk metabolite for cardiovascular disease.\n\nThe gut microbiota composition was reported to be altered in MetS. After ingestion of foods high in trimethylamine moieties, postprandial TMAO in blood may differ between subjects with and without MetS because of their different microbiota profiles.\n\nAim of the study is to investigate in subjects with and without MetS the postprandial TMAO concentrations in blood and urine in association with the gut microbiota profile after ingestion of choline- and L-carnitine-rich foods.\n\nThirty-three subjects aged 18-75 years with (n=12) or without MetS (n=21) were recruited.\n\nSubjects received on two occasions, after overnight fasting, either three hard-boiled eggs or 170 g meatballs.\n\nBlood samples were collected (before ingestion of food, and at 30, 60, 120, 240, and 360 minutes after ingestion). A composite urine sample was collected over 6 hours. A feces sample was collected on the day before the first intervention.\n\nConcentrations of TMAO, trimethylamine, betaine, choline, L-carnitine, acetyl-L-carnitine, and creatinine were measured UPLC-MRM-MS. The incremental area under the curve (iAUC) was calculated for each compound.\n\nTMAO, trimethylamine, betaine, choline, L-carnitine, acetyl-L-carnitine, and creatinine were analyzed in composite urine samples using UPLC-MRM-MS.\n\nGut microbiome analysis was done by full 16S rRNA gene sequencing using the Oxford Nanopore Technology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria for all subjects with and without MetS:\n\n* Age = 18-75y\n* Plasma creatinine value within the age-related reference range\n* No history of acute or chronic diseases (e.g. diabetes or bowel disease)\n* No use of vitamin or mineral supplements, no medication with antibiotics 2 months before recruitment and during the study\n* Non-smoker\n* Not consuming a special diet (vegetarian)\n* No pregnancy, planned conception, or lactation\n* No participation in another study.\n\nInclusion criteria for subjects without MetS:\n\n* Normal BMI (18.6 to 29.0 kg / m 2 )\n* Blood counts within reference ranges\n* Normal ranges for liver enzymes (P-ALAT, P-AST, P-ALP), blood status, plasma triglycerides, plasma HDL cholesterol, plasma cholesterol, plasma glucose\n\nInclusion criteria for subjects with MetS:\n\nA minimum of three of the following criteria according the National Cholesterol Education Program Adult Treatment Panel (NCEP-ATP III):\n\n* Waist size \\> 102 cm in men, \\> 88 cm in women\n* Fasting plasma glucose ≥ 5.6 mmol /l\n* Triglycerides \\> 1.7 mmol / l or treatment\n* HDL 1.03 mmol / l in men, 1.29 mmol / l in women or treatment\n* Blood pressure ≥ 130 / 85 mm Hg or medication. A value of B-HbA1c in the age-related reference range will be used to exclude diabetes.\n\nExclusion criteria for all research subjects :\n\n* Smoker\n* Pregnancy, planned conception, or lactation\n* Medical treatment with antibiotics 2 months before recruitment and during the study\n* Use of dietary supplements 2 weeks before and during the study\n* Use of probiotics 2 months before and during the study\n* Following a special diet (eg vegan, vegetarian, weight loss)\n* Participation in another study'}, 'identificationModule': {'nctId': 'NCT06660251', 'briefTitle': 'Effect of Meat and Egg on TMAO in Plasma and Urine in Subjects with and Metabolic Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Linnaeus University'}, 'officialTitle': 'Trimethylamine-N-oxide After Animal Food - Effects of Gut Microbiota in Subjects with and Without Metabolic Syndrome', 'orgStudyIdInfo': {'id': '2019-04354'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Subjects with MetS', 'description': 'Subjects with a minimum of three criteria according to NCEP-ATP III. Subjects were administered in randomized order after overnight fasting a test food. Test days were on two separate occasions around 2 weeks apart.\n\nEgg intervention: three hard-boiled eggs. Meatball intervention: 170 g meatballs.', 'interventionNames': ['Other: Egg intervention', 'Other: Meatball intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Subjects without MetS', 'description': 'Subjects, apparently healthy, with normal BMI, blood pressure, waist circumference (see inclusion criteria). Subjects were administered in randomized order after overnight fasting a test food. Test days were on two separate occasions around 2 weeks apart.\n\nEgg intervention: three hard-boiled eggs. Meatball intervention: 170 g meatballs.', 'interventionNames': ['Other: Egg intervention', 'Other: Meatball intervention']}], 'interventions': [{'name': 'Egg intervention', 'type': 'OTHER', 'description': 'Oral administration of three hard-boiled eggs to be ingested within 15 minutes on one occasion.', 'armGroupLabels': ['Subjects with MetS', 'Subjects without MetS']}, {'name': 'Meatball intervention', 'type': 'OTHER', 'description': 'Oral intervention with 170 g meatballs to be ingested within 15 minutes on one occasion.', 'armGroupLabels': ['Subjects with MetS', 'Subjects without MetS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '392 31', 'city': 'Kalmar', 'country': 'Sweden', 'facility': 'Faculty of Health and Life Sciences, Linnaeus University', 'geoPoint': {'lat': 56.66157, 'lon': 16.36163}}], 'overallOfficials': [{'name': 'Mohammed E Hefni, Assoc Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Linnaeus University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to share individual data as all data will be presented in the main article through tables and figures or in the supplementary material as mean ± standard deviation. However, individual data will be made available upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linnaeus University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Umeå University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc Prof', 'investigatorFullName': 'Mohammed Hefni', 'investigatorAffiliation': 'Linnaeus University'}}}}