Clinical trial

The Metabolic Effects of Oral Tributyrin Administration

Recruiting now · Not applicable · 1 countries · Registry ID NCT07463495

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionHealthy Overweight/Obese

Full registry 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

Treatments and study arms

tributyrin

Dietary Supplement

Oral ingestion of tributyrin (liquid) once daily (20 g x 1) for 7 days, then twice daily (20 g x 2) for 7 days.

Control

Dietary Supplement

Oral ingestion of water (liquid) with added bitter substance once daily (20 ml x 1) for 7 days, then twice daily (20 ml x 2) for 7 days

Primary outcomes

Postprandial glucoseDuring trial day, time 120-300 minutes

iAUC of plasma glucose after ingestion of mixed meal

Study locations

1 locations were listed when this page was built. The first 40 are shown.

SDCA / Medical Research Laboratory🇩🇰 Aarhus N, Denmark

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Simon M Denning, MDContact

Email · Call 004578450000