The Metabolic Effects of Oral Tributyrin Administration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: tributyrin, Control.
- Who it may be relevant to
- Registry conditions: Healthy Overweight/Obese. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Metabolic Effects of Oral Tributyrin Administration in Overweight/Obese Individuals
Overview
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.
Interventions
- Dietary supplement tributyrin
Oral ingestion of tributyrin (liquid) once daily (20 g x 1) for 7 days, then twice daily (20 g x 2) for 7 days. - Dietary supplement Control
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 outcome measures
- Postprandial glucose [Time frame: During trial day, time 120-300 minutes]
Secondary outcome measures (12)
- Butyrate [Time frame: During trial day, time 0-300 minutes]
- Subjective appetite - appetite questionaire [Time frame: 0, 60, 120, 180, 240, 300 minutes]
- Caloric intake [Time frame: Time 300 minutes]
- Gastric emptying assessed by acetaminophen [Time frame: From ingestion of mixed meal test with acetaminophen, time 120-240 minutes]
- GLP-1 [Time frame: During trial day, time 0-300 minutes]
- GIP [Time frame: During trial day, time 0-300 minutes]
- LEAP2 [Time frame: During trial day, time 0-300 minutes]
- PYY [Time frame: During trial day, time 0-300 minutes]
- Ghrelin [Time frame: During trial day, time 0-300 minutes]
- Insulin [Time frame: During trial day, time 0-300 minutes]
- C-peptide [Time frame: During trial day, time 0-300 minutes]
- Glucagon [Time frame: During trial day, time 0-300 minutes]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Other
Study locations
Denmark · 1 center
- SDCA / Medical Research Laboratory — Aarhus N
Identifiers
NCT: NCT07463495 · 1-10-72-110-25