The Metabolic Effects of Oral Tributyrin Administration

Recruiting now · Not applicable

Conditions studied: Healthy Overweight/Obese

In brief

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 echocardiography is anticipated to be published separately. * Caloric intake (ad libitum meal test) * Gastric emptying rate (acetaminophen test) * Resting metabolic rate (indirect calorimetry). While 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.

Key facts

Study ID

NCT07463495

Run by

University of Aarhus

People needed

12

Starts

2026-02-20

Expected to finish

2026-12-01

Last updated by the study team

2026-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• SDCA / Medical Research Laboratory — Aarhus N, Denmark (enrolling)

Full record on ClinicalTrials.gov

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