SDCA / Medical Research Laboratory
Aarhus N, 8200, Denmark
Location status: Recruiting
Recruiting
NCT Number: NCT07463495
The Metabolic Effects of Oral Tributyrin Administration
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Tributyrin
Dietary SupplementOral 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 SupplementOral 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 glucose
Time frame: During trial day, time 120-300 minutes
iAUC of plasma glucose after ingestion of mixed meal
Secondary outcomes
-
Butyrate
Time frame: During trial day, time 0-300 minutes
Plasma concentrations of butyrate
-
Subjective appetite - appetite questionaire
Time frame: 0, 60, 120, 180, 240, 300 minutes
We will assess subjective appetite sensations with a recommended primary scale for self-reported appetite in healthy adults. The scale includes five questions addressing hunger, fullness, satiety, desire to eat and prospective consumption. The participants answer on a computer or tablet by sliding a button on a horizontal line (Visual Analog Scale) with left being eg. "Not hungry at all" to right "As hungry as I have ever felt".
-
Caloric intake
Time frame: Time 300 minutes
Caloric intake (kcal) during ad libitum meal test
-
Gastric emptying assessed by acetaminophen
Time frame: From ingestion of mixed meal test with acetaminophen, time 120-240 minutes
Plasma concentration of acetaminophen following oral acetaminophen intake
-
GLP-1
Time frame: During trial day, time 0-300 minutes
Plasma concentrations of GLP-1
-
GIP
Time frame: During trial day, time 0-300 minutes
Plasma concentrations of GIP
-
LEAP2
Time frame: During trial day, time 0-300 minutes
Plasma concentrations of LEAP2
-
PYY
Time frame: During trial day, time 0-300 minutes
Plasma concentrations of PYY
-
Ghrelin
Time frame: During trial day, time 0-300 minutes
Plasma concentrations of ghrelin
-
Insulin
Time frame: During trial day, time 0-300 minutes
Plasma concentrations of insulin
-
C-peptide
Time frame: During trial day, time 0-300 minutes
Plasma concentrations of c-peptide
-
Glucagon
Time frame: During trial day, time 0-300 minutes
Plasma concentrations of glucagon
-
Cardiac function
Time frame: Time 0 and 90 minutes
Echocardiographic assessment of cardiac output, left ventricular ejection fraction, global longitudinal strain, tricuspid annular plane systolic excursion (TAPSE), systemic vascular resistance
-
β-hydroxybutyrate
Time frame: During trial day, time 0-300 minutes
Plasma concentrations of β-hydroxybutyrate
-
Lactate
Time frame: During trial day, time 0-300 minutes
Plasma concentrations of lactate
-
C-reactive protein (CRP)
Time frame: On trial day, time 0 minutes
Plasma concentrations of CRP
-
Tumor Necrosis Factor ⍺ (TNF-⍺)
Time frame: On trial day, time 0 minutes
Plasma concentrations of TNF-⍺
-
Interleukin 6 (IL-6)
Time frame: On trial day, time 0 minutes
Plasma concentrations of IL-6
-
Interleukin 10 (IL-10)
Time frame: On trial day, time 0 minutes
Plasma concentrations of IL-10
-
Lipopolysaccharide Binding Protein (LPB)
Time frame: On trial day, time 0 minutes
Plasma concentrations of LPB
-
Cortisol
Time frame: On trial day, time 0 minutes
Plasma concentration of cortisol
-
Triglyceride
Time frame: During trial day, time 0-300 minutes
Plasma concentrations of triglyceride
-
FFA
Time frame: During trial day, time 0-300 minutes
Plasma concentrations of free fatty acids
-
Energy expenditure
Time frame: After 60 and 150 minutes approximately
Indirect calorimetry
-
Sleep
Time frame: Three nights at the end of the 2 week period at home
Assessment of sleep duration and stages
-
Fecal butyrate
Time frame: Day 0, 7, 14 during the 2 week period
Fecal concentrations of butyrate
-
Microbiome composition
Time frame: Day 0, 7, 14 during the 2 week period
Analysis of microbiome composition and metagenomics performed on fecal samples
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Aarhus
Other
Registry information
Official study title
The Metabolic Effects of Oral Tributyrin Administration in Overweight/Obese Individuals
Acronym: TRIMET
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Mar 11, 2026
- Registry last updated
- Mar 16, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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