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The Metabolic Effects of Oral Tributyrin Administration

NCT07463495 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-03-16

No results posted yet for this 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.

Conditions

  • Healthy Overweight/Obese

Interventions

DIETARY_SUPPLEMENT

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.

DIETARY_SUPPLEMENT

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

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-20
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07463495 on ClinicalTrials.gov