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The Metabolic Effects of Oral Tributyrin Administration

RecruitingNAAges 18 Years - anyAllUniversity of Aarhus
NCT07463495 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. The main questions it aims to answer are: * Does tributyrin have glucose lowering properties in humans? * Does tributyrin reduce appetite in humans? A 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: * Postprandial blood sugar levels * Hunger sensations (questionnaire) * Enteroendocrine hormone secretion (GLP-1, GIP, PYY, LEAP2, ghrelin) * Cardiac function (echocardiography) - An exploratory study evaluating the hemodynamic effects assessed by echocard

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📋 Eligibility rules (as published)
Inclusion Criteria: * A body mass index (BMI) between 30-45 kg/m2 * Older than 18 years of age * HbA1c \< 48 mmol/mol * Hemoglobin within normal range (females: 7.3-9.5 mmol/L, males: 8.3-10.5 mmol/L) * Written and oral consent to participate Exclusion Criteria: * Medications affecting glucose metabolism and/or appetite (e.g. insulin, metformin, GLP-1 analogues) * Special diet (HCLF, ketogenic diets, vegan/vegetarian) * Ongoing cancer or other acute/chronic serious diseases (determined by PI) * Inability to understand Danish or English * Abnormal blood samples at screening visit (determined by PI and co-investigators) * Deemed unsuitable to participate by the PI and co-investigators
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What it tests

  • tributyrin
  • Control
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Where

1 site
SDCA / Medical Research Laboratory
Aarhus N, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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