NCT07463495 The Metabolic Effects of Oral Tributyrin Administration
| NCT ID | NCT07463495 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Healthy Overweight/Obese |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-02-20 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2026-02-20 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07463495 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Healthy Overweight/Obese. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07463495 currently recruiting?
Yes, NCT07463495 is actively recruiting participants. Contact the research team at simon.denning@clin.au.dk for enrollment information.
Where is the NCT07463495 trial being conducted?
This trial is being conducted at Aarhus N, Denmark.
Who is sponsoring the NCT07463495 clinical trial?
NCT07463495 is sponsored by University of Aarhus. The trial plans to enroll 12 participants.