Healthy Overweight/ObeseTRIMETNCT07463495
The Metabolic Effects of Oral Tributyrin Administration
A study testing tributyrin in people with Healthy Overweight/Obese, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy Overweight/Obese
- What is being tested?
- tributyrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Feb 2026to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
SDCA / Medical Research Laboratory
Aarhus N, 8200
Simon M Denning, MD, 004578450000, simon.denning@clin.au.dk
About this study
Official title: The Metabolic Effects of Oral Tributyrin Administration in Overweight/Obese Individuals
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:
Read more
- 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
- Being tested
- tributyrin, Control
- Keywords
- Appetite, Glucose metabolism, Butyrate, Tributyrin
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tributyrinDietary 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.
ControlDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Oral tributyrin | Experimental | Oral ingestion of tributyrin Receives: Dietary Supplement: tributyrin |
| Control | Placebo comparator | Oral ingestion of placebo Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glucose
iAUC of plasma glucose after ingestion of mixed meal
Measured: During trial day, time 120-300 minutes
Secondary outcomes (27)
Butyrate
Plasma concentrations of butyrate
Measured: During trial day, time 0-300 minutes
Subjective appetite - appetite questionaire
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".
Measured: 0, 60, 120, 180, 240, 300 minutes
Caloric intake
Caloric intake (kcal) during ad libitum meal test
Measured: Time 300 minutes
Gastric emptying assessed by acetaminophen
Plasma concentration of acetaminophen following oral acetaminophen intake
Measured: From ingestion of mixed meal test with acetaminophen, time 120-240 minutes
GLP-1
Plasma concentrations of GLP-1
Measured: During trial day, time 0-300 minutes
GIP
Plasma concentrations of GIP
Measured: During trial day, time 0-300 minutes
LEAP2
Plasma concentrations of LEAP2
Measured: During trial day, time 0-300 minutes
PYY
Plasma concentrations of PYY
Measured: During trial day, time 0-300 minutes
Ghrelin
Plasma concentrations of ghrelin
Measured: During trial day, time 0-300 minutes
Insulin
Plasma concentrations of insulin
Measured: During trial day, time 0-300 minutes
C-peptide
Plasma concentrations of c-peptide
Measured: During trial day, time 0-300 minutes
Glucagon
Plasma concentrations of glucagon
Measured: During trial day, time 0-300 minutes
Cardiac function
Echocardiographic assessment of cardiac output, left ventricular ejection fraction, global longitudinal strain, tricuspid annular plane systolic excursion (TAPSE), systemic vascular resistance
Measured: Time 0 and 90 minutes
β-hydroxybutyrate
Plasma concentrations of β-hydroxybutyrate
Measured: During trial day, time 0-300 minutes
Lactate
Plasma concentrations of lactate
Measured: During trial day, time 0-300 minutes
C-reactive protein (CRP)
Plasma concentrations of CRP
Measured: On trial day, time 0 minutes
Tumor Necrosis Factor ⍺ (TNF-⍺)
Plasma concentrations of TNF-⍺
Measured: On trial day, time 0 minutes
Interleukin 6 (IL-6)
Plasma concentrations of IL-6
Measured: On trial day, time 0 minutes
Interleukin 10 (IL-10)
Plasma concentrations of IL-10
Measured: On trial day, time 0 minutes
Lipopolysaccharide Binding Protein (LPB)
Plasma concentrations of LPB
Measured: On trial day, time 0 minutes
Cortisol
Plasma concentration of cortisol
Measured: On trial day, time 0 minutes
Triglyceride
Plasma concentrations of triglyceride
Measured: During trial day, time 0-300 minutes
FFA
Plasma concentrations of free fatty acids
Measured: During trial day, time 0-300 minutes
Energy expenditure
Indirect calorimetry
Measured: After 60 and 150 minutes approximately
Sleep
Assessment of sleep duration and stages
Measured: Three nights at the end of the 2 week period at home
Fecal butyrate
Fecal concentrations of butyrate
Measured: Day 0, 7, 14 during the 2 week period
Microbiome composition
Analysis of microbiome composition and metagenomics performed on fecal samples
Measured: Day 0, 7, 14 during the 2 week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start20 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Overweight/ObeseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463495
- Sponsor's protocol ID
- 1-10-72-110-25
- Acronym
- TRIMET
- Status last verified
- Nov 2025
- First submitted
- 5 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The corresponding author will make data available on reasonable request.