The Metabolic Effects of Oral Tributyrin Administration

NCT07463495 | Recruiting

• 1 other identifier: 1-10-72-110-25
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Overweight/Obese

Keywords

Appetite; Glucose metabolism; Butyrate; Tributyrin

Outcome Measures

Primary Outcomes (1)

• Postprandial glucose

  iAUC of plasma glucose after ingestion of mixed meal

  During trial day, time 120-300 minutes

Secondary Outcomes (27)

• Butyrate

  During trial day, time 0-300 minutes

• Subjective appetite - appetite questionaire

  0, 60, 120, 180, 240, 300 minutes

• Caloric intake

  Time 300 minutes

• Gastric emptying assessed by acetaminophen

  From ingestion of mixed meal test with acetaminophen, time 120-240 minutes

• GLP-1

  During trial day, time 0-300 minutes

Study Arms (2)

Oral tributyrin

EXPERIMENTAL

Oral ingestion of tributyrin

Dietary Supplement: tributyrin

Control

PLACEBO COMPARATOR

Oral ingestion of placebo

Dietary Supplement: Control

Interventions

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.

Oral tributyrin

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

SDCA / Medical Research Laboratory

Aarhus N, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

tributyrin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Simon M Denning, MD

CONTACT

0045 78450000; simon.denning@clin.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 11, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)