NCT07463495Recruiting
The Metabolic Effects of Oral Tributyrin Administration
The Metabolic Effects of Oral Tributyrin Administration in Overweight/Obese Individuals
Source: ClinicalTrials.gov · Last updated 16 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 5 Mar 2026
- Start date
- 20 Feb 2026
- Primary completion date
- Dec 2026
- Lead sponsor
- University of Aarhus
- Diseases
- Obesity
- NCT number
- NCT07463495
What you commit to
- Study type: Interventional
- Planned participants: 12
- From 20 Feb 2026 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Ongoing cancer or other acute/chronic serious diseases (determined by PI)
Lab values
- Medications affecting glucose metabolism and/or appetite (e.g. insulin, metformin, GLP-1 analogues)
Other
- Special diet (HCLF, ketogenic diets, vegan/vegetarian)
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SDCA / Medical Research Laboratory Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.