Oral tributyrin for metabolic control and appetite in adults with obesity

The Metabolic Effects of Oral Tributyrin Administration in Overweight/Obese Individuals

This study will test whether taking oral tributyrin can lower post-meal blood sugar and reduce appetite in adults with obesity.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Aarhus (other)
• Locations: 1 site (Aarhus N)
• Trial ID: NCT07463495 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind crossover trial enrolls about 12 adults with obesity who receive oral tributyrin or placebo for two 2-week periods separated by at least a 2-week washout. Dosing is once or twice daily and participants undergo post-treatment testing including postprandial glucose, hunger questionnaires, enteroendocrine hormones (GLP-1, GIP, PYY, LEAP2, ghrelin), and an ad libitum meal test for caloric intake; echocardiography is included as an exploratory hemodynamic endpoint. The within-subject crossover design increases power for a small sample and excludes medications or special diets that affect glucose or appetite to reduce confounding. Safety labs and screening ensure participants are generally healthy aside from overweight/obesity.

Who should consider this trial

Good fit: Adults aged 18 or older with BMI 30–45 kg/m2, HbA1c below 48 mmol/mol, normal hemoglobin, and not taking glucose- or appetite-altering medications are ideal candidates.

Not a fit: People with diabetes, on glucose-lowering or appetite-modifying drugs, following special diets, or with serious acute/chronic illness are unlikely to be eligible or to benefit from this short exploratory intervention.

Why it matters

Potential benefit: If successful, this approach could offer a simple oral way to improve post-meal glucose control and reduce appetite in people with obesity.

How similar studies have performed: Preclinical work and a few small human studies of butyrate or tributyrin suggest metabolic and appetite effects, but human evidence is limited and inconsistent.

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

Where this trial is running

Aarhus N

• SDCA / Medical Research Laboratory — Aarhus N, Denmark (RECRUITING)

Study contacts

• Study coordinator: Simon M Denning, MD

Conditions: Healthy Overweight/Obese, Appetite, Glucose metabolism, Butyrate, Tributyrin