Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:15 AM
Study NCT ID:
NCT07463495
Status:
RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Metabolic Effects of Oral Tributyrin Administration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005830', 'term': 'tributyrin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-03-05', 'studyFirstSubmitQcDate': '2026-03-05', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postprandial glucose', 'timeFrame': 'During trial day, time 120-300 minutes', 'description': 'iAUC of plasma glucose after ingestion of mixed meal'}], 'secondaryOutcomes': [{'measure': 'Butyrate', 'timeFrame': 'During trial day, time 0-300 minutes', 'description': 'Plasma concentrations of butyrate'}, {'measure': 'Subjective appetite - appetite questionaire', 'timeFrame': '0, 60, 120, 180, 240, 300 minutes', 'description': 'We will assess subjective appetite sensations with a recommended primary scale for self-reported appetite in healthy adults. The scale includes five questions addressing hunger, fullness, satiety, desire to eat and prospective consumption. The participants answer on a computer or tablet by sliding a button on a horizontal line (Visual Analog Scale) with left being eg. "Not hungry at all" to right "As hungry as I have ever felt".'}, {'measure': 'Caloric intake', 'timeFrame': 'Time 300 minutes', 'description': 'Caloric intake (kcal) during ad libitum meal test'}, {'measure': 'Gastric emptying assessed by acetaminophen', 'timeFrame': 'From ingestion of mixed meal test with acetaminophen, time 120-240 minutes', 'description': 'Plasma concentration of acetaminophen following oral acetaminophen intake'}, {'measure': 'GLP-1', 'timeFrame': 'During trial day, time 0-300 minutes', 'description': 'Plasma concentrations of GLP-1'}, {'measure': 'GIP', 'timeFrame': 'During trial day, time 0-300 minutes', 'description': 'Plasma concentrations of GIP'}, {'measure': 'LEAP2', 'timeFrame': 'During trial day, time 0-300 minutes', 'description': 'Plasma concentrations of LEAP2'}, {'measure': 'PYY', 'timeFrame': 'During trial day, time 0-300 minutes', 'description': 'Plasma concentrations of PYY'}, {'measure': 'Ghrelin', 'timeFrame': 'During trial day, time 0-300 minutes', 'description': 'Plasma concentrations of ghrelin'}, {'measure': 'Insulin', 'timeFrame': 'During trial day, time 0-300 minutes', 'description': 'Plasma concentrations of insulin'}, {'measure': 'C-peptide', 'timeFrame': 'During trial day, time 0-300 minutes', 'description': 'Plasma concentrations of c-peptide'}, {'measure': 'Glucagon', 'timeFrame': 'During trial day, time 0-300 minutes', 'description': 'Plasma concentrations of glucagon'}, {'measure': 'Cardiac function', 'timeFrame': 'Time 0 and 90 minutes', 'description': 'Echocardiographic assessment of cardiac output, left ventricular ejection fraction, global longitudinal strain, tricuspid annular plane systolic excursion (TAPSE), systemic vascular resistance'}, {'measure': 'β-hydroxybutyrate', 'timeFrame': 'During trial day, time 0-300 minutes', 'description': 'Plasma concentrations of β-hydroxybutyrate'}, {'measure': 'Lactate', 'timeFrame': 'During trial day, time 0-300 minutes', 'description': 'Plasma concentrations of lactate'}, {'measure': 'C-reactive protein (CRP)', 'timeFrame': 'On trial day, time 0 minutes', 'description': 'Plasma concentrations of CRP'}, {'measure': 'Tumor Necrosis Factor ⍺ (TNF-⍺)', 'timeFrame': 'On trial day, time 0 minutes', 'description': 'Plasma concentrations of TNF-⍺'}, {'measure': 'Interleukin 6 (IL-6)', 'timeFrame': 'On trial day, time 0 minutes', 'description': 'Plasma concentrations of IL-6'}, {'measure': 'Interleukin 10 (IL-10)', 'timeFrame': 'On trial day, time 0 minutes', 'description': 'Plasma concentrations of IL-10'}, {'measure': 'Lipopolysaccharide Binding Protein (LPB)', 'timeFrame': 'On trial day, time 0 minutes', 'description': 'Plasma concentrations of LPB'}, {'measure': 'Cortisol', 'timeFrame': 'On trial day, time 0 minutes', 'description': 'Plasma concentration of cortisol'}, {'measure': 'Triglyceride', 'timeFrame': 'During trial day, time 0-300 minutes', 'description': 'Plasma concentrations of triglyceride'}, {'measure': 'FFA', 'timeFrame': 'During trial day, time 0-300 minutes', 'description': 'Plasma concentrations of free fatty acids'}, {'measure': 'Energy expenditure', 'timeFrame': 'After 60 and 150 minutes approximately', 'description': 'Indirect calorimetry'}, {'measure': 'Sleep', 'timeFrame': 'Three nights at the end of the 2 week period at home', 'description': 'Assessment of sleep duration and stages'}, {'measure': 'Fecal butyrate', 'timeFrame': 'Day 0, 7, 14 during the 2 week period', 'description': 'Fecal concentrations of butyrate'}, {'measure': 'Microbiome composition', 'timeFrame': 'Day 0, 7, 14 during the 2 week period', 'description': 'Analysis of microbiome composition and metagenomics performed on fecal samples'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Appetite', 'Glucose metabolism', 'Butyrate', 'Tributyrin'], 'conditions': ['Healthy Overweight/Obese']}, 'descriptionModule': {'briefSummary': 'The goal of this double-blinded randomized clinical cross-over trial is to investigate the metabolic and appetite regulating effects of oral tributyrin (a butyrate pro-drug) administration vs placebo.\n\nThe main questions it aims to answer are:\n\n* Does tributyrin have glucose lowering properties in humans?\n* Does tributyrin reduce appetite in humans?\n\nA sample size calculation estimated a minimum of 10 participants. We expect to include 12 participants in this study. Tributyrin or placebo is ingested once or twice daily for 2x2 weeks, separated by a washout period of minimum 2 weeks. On trial day following each 2-week period we assess:\n\n* Postprandial blood sugar levels\n* Hunger sensations (questionnaire)\n* Enteroendocrine hormone secretion (GLP-1, GIP, PYY, LEAP2, ghrelin)\n* Cardiac function (echocardiography) - An exploratory study evaluating the hemodynamic effects assessed by echocardiography is anticipated to be published separately.\n* Caloric intake (ad libitum meal test)\n* Gastric emptying rate (acetaminophen test)\n* Resting metabolic rate (indirect calorimetry).\n\nWhile at home, subjects will wear a sleep monitoring device for three consecutive nights and deliver fecal samples for analysis of short-chain fatty acid content and microbiota composition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A body mass index (BMI) between 30-45 kg/m2\n* Older than 18 years of age\n* HbA1c \\< 48 mmol/mol\n* Hemoglobin within normal range (females: 7.3-9.5 mmol/L, males: 8.3-10.5 mmol/L)\n* Written and oral consent to participate\n\nExclusion Criteria:\n\n* Medications affecting glucose metabolism and/or appetite (e.g. insulin, metformin, GLP-1 analogues)\n* Special diet (HCLF, ketogenic diets, vegan/vegetarian)\n* Ongoing cancer or other acute/chronic serious diseases (determined by PI)\n* Inability to understand Danish or English\n* Abnormal blood samples at screening visit (determined by PI and co-investigators)\n* Deemed unsuitable to participate by the PI and co-investigators'}, 'identificationModule': {'nctId': 'NCT07463495', 'acronym': 'TRIMET', 'briefTitle': 'The Metabolic Effects of Oral Tributyrin Administration', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'The Metabolic Effects of Oral Tributyrin Administration in Overweight/Obese Individuals', 'orgStudyIdInfo': {'id': '1-10-72-110-25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral tributyrin', 'description': 'Oral ingestion of tributyrin', 'interventionNames': ['Dietary Supplement: tributyrin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Oral ingestion of placebo', 'interventionNames': ['Dietary Supplement: Control']}], 'interventions': [{'name': 'tributyrin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral ingestion of tributyrin (liquid) once daily (20 g x 1) for 7 days, then twice daily (20 g x 2) for 7 days.', 'armGroupLabels': ['Oral tributyrin']}, {'name': 'Control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral ingestion of water (liquid) with added bitter substance once daily (20 ml x 1) for 7 days, then twice daily (20 ml x 2) for 7 days', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Simon M Denning, MD', 'role': 'CONTACT', 'email': 'simon.denning@clin.au.dk', 'phone': '004578450000'}], 'facility': 'SDCA / Medical Research Laboratory', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}], 'centralContacts': [{'name': 'Simon M Denning, MD', 'role': 'CONTACT', 'email': 'simon.denning@clin.au.dk', 'phone': '0045 78450000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The corresponding author will make data available on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}