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:
University of Aarhus
Organization:
Study Overview
Official Title:
The Metabolic Effects of Oral Tributyrin Administration in Overweight/Obese Individuals
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIMET
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: