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Clinical Trials in Denmark / NCT07463495
Recruiting Not applicable

The Metabolic Effects of Oral Tributyrin Administration

NCT07463495 · tracked via the Priya Life Science Denmark tracker
Sponsor
University of Aarhus
Phase
Not applicable
Started
2026-02-20
Last updated
2026-03-16

Condition(s) studied

Healthy Overweight/Obese

Investigational drug(s) / intervention(s)

tributyrinControl

tributyrin: Oral ingestion of tributyrin (liquid) once daily (20 g x 1) for 7 days, then twice daily (20 g x 2) for 7 days.

Control: 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

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Postprandial glucose — During trial day, time 120-300 minutes
    iAUC of plasma glucose after ingestion of mixed meal

Trial sites (1)

FacilityCityRegionStatus
SDCA / Medical Research Laboratory Aarhus N Denmark Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07463495 on ClinicalTrials.gov ↗ ← All trials in Denmark