The Metabolic Effects of Oral Tributyrin Administration
Recruiting · NCT07463495 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Aarhus
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- SDCA / Medical Research Laboratory - Aarhus N, Denmark