Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07463495
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.
Study:
NCT07463495
Study Brief:
Protocol Section:
NCT07463495