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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolic Effects of Oral Tributyrin Administration in Overweight/Obese Individuals
- ClinicalTrials.gov ID
- NCT07463495
- Acronym / sponsor ID
- TRIMET / 1-10-72-110-25
- Conditions
- Healthy Overweight/Obese
- Keywords
- Appetite, Glucose metabolism, Butyrate, Tributyrin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral tributyrin | Experimental | Dietary Supplement: tributyrinOral ingestion of tributyrin |
| Control | Placebo comparator | Dietary Supplement: ControlOral ingestion of placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tributyrinOral 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 | Oral tributyrin |
| ControlOral 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 | Dietary supplement | Control |
Primary outcome
Postprandial glucose
Time frame: During trial day, time 120-300 minutes
iAUC of plasma glucose after ingestion of mixed meal
27 secondary outcomes
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
Cardiac function
Time frame: Time 0 and 90 minutes
β-hydroxybutyrate
Time frame: During trial day, time 0-300 minutes
Lactate
Time frame: During trial day, time 0-300 minutes
C-reactive protein (CRP)
Time frame: On trial day, time 0 minutes
Tumor Necrosis Factor ⍺ (TNF-⍺)
Time frame: On trial day, time 0 minutes
Interleukin 6 (IL-6)
Time frame: On trial day, time 0 minutes
Interleukin 10 (IL-10)
Time frame: On trial day, time 0 minutes
Lipopolysaccharide Binding Protein (LPB)
Time frame: On trial day, time 0 minutes
Cortisol
Time frame: On trial day, time 0 minutes
Triglyceride
Time frame: During trial day, time 0-300 minutes
FFA
Time frame: During trial day, time 0-300 minutes
Energy expenditure
Time frame: After 60 and 150 minutes approximately
Sleep
Time frame: Three nights at the end of the 2 week period at home
Fecal butyrate
Time frame: Day 0, 7, 14 during the 2 week period
Microbiome composition
Time frame: Day 0, 7, 14 during the 2 week period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No. The corresponding author will make data available on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tributyrin in people with Healthy Overweight/Obese, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon M Denning, MD (0045 78450000, simon.denning@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial glucose (time frame: During trial day, time 120-300 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.