Cardiometabolic ConditionsNAT-INCNCT07771166
Effects of N-Acyl Taurines on Incretin Levels in Healthy Subjects
A study testing Arachidonoyl-taurine: First dose at 0 hours, Oleoyl-taurine: First dose at 0 hours and Liquid meal and second dose of OLE-T at 3 hours in people with Cardiometabolic Conditions, run by University Hospital, Gentofte, Copenhagen.
Trial summary
This study is an investigator-initiated, randomised, double-blind, placebo-controlled, cross-over human trial investigating the effect of arachidonoyl-taurine (C20:4-taurine) and oleoyl-taurine (C18:1-taurine) on GLP-1 secretion during fasting and feeding. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Conditions
- What is being tested?
- Arachidonoyl-taurine: First dose at 0 hours, Oleoyl-taurine: First dose at 0 hours and Liquid meal and second dose of OLE-T at 3 hours
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jun 2027to Dec 2028
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 45 years
- Body mass index between 18.5-27 kg/m2
- Informed consent
- Weight stable in the past 3 months
Who cannot join
- Regular tobacco smoking or use of other nicotine-containing products
- Allergy or intolerance to ingredients included in the test compounds or standardised meals
- Glycated haemoglobin (HbA1c) >48 mmol/mol
- Anaemia (haemoglobin below 8.3 mmol/L)
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2 times upper normal values (Normal values: ALT < 70 U/L, AST <45 U/L)
- Nephropathy (eGFR<90mL/min/1.73 m2) and/or albuminuria (>30 mg/g albumin in urine))
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- Women of childbearing potential who are not using effective contraception
- Pregnancy or breastfeeding
- History of hepatobiliary or gastrointestinal disorder(s)
- Use of weight loss medication within the last 6 months
- Any physical or psychological condition, or ongoing medication, that the investigator evaluates would interfere with trial participation, including any acute or chronic illnesses
About this study
Official title: Effects of N-Acyl Taurines on Incretin Levels in Healthy Subjects: a Randomised, Double-blind, Placebo-controlled, Cross-over Study
This study is an investigator-initiated, randomised, double-blind, placebo-controlled, cross-over human trial investigating the effect of arachidonoyl-taurine (C20:4-taurine) and oleoyl-taurine (C18:1-taurine) on GLP-1 secretion during fasting and feeding.
- Conditions
- Cardiometabolic Conditions
- Being tested
- Placebo: First dose at 0 hours, Arachidonoyl-taurine: First dose at 0 hours, Oleoyl-taurine: First dose at 0 hours, Liquid meal and second dose of placebo at 3 hours, Liquid meal and second dose of OLE-T at 3 hours
- Keywords
- Glucagon-like peptide 1, N-acyl taurine, GPR119
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo: First dose at 0 hoursOther
Vehicle (ultrapure water with 10 % fish sauce), orally administered
Arachidonoyl-taurine: First dose at 0 hoursOther
Arachidonoyl-taurine (2 mg/kg) dissolved in ultrapure water with 10 % fish sauce, orally administered
Oleoyl-taurine: First dose at 0 hoursOther
Oleoyl-taurine (2 mg/kg) dissolved in ultrapure water with 10 % fish sauce, orally administered
Liquid meal and second dose of placebo at 3 hoursOther
Liquid meal with 1.5 g paracetamol. Administered with a second dose of: Vehicle (ultrapure water with 10 % fish sauce), orally administered
Liquid meal and second dose of OLE-T at 3 hoursOther
Liquid meal with 1.5 g paracetamol. Administered with a second dose of: Oleoyl-taurine (2 mg/kg) dissolved in ultrapure water with 10 % fish sauce, orally administered
Liquid meal and second dose of ARA-T at 3 hoursOther
Liquid meal with 1.5 g paracetamol. Administered with a second dose of: Arachidonoyl-taurine (2 mg/kg) dissolved in ultrapure water with 10 % fish sauce, orally administered
| Study group | Role | What they receive |
|---|---|---|
| Vehicle | Placebo comparator | Not described Receives: Other: Placebo: First dose at 0 hours; Other: Liquid meal and second dose of placebo at 3 hours |
| ARA-T | Experimental | Not described Receives: Other: Arachidonoyl-taurine: First dose at 0 hours; Other: Liquid meal and second dose of ARA-T at 3 hours |
| OLE-T | Experimental | Not described Receives: Other: Oleoyl-taurine: First dose at 0 hours; Other: Liquid meal and second dose of OLE-T at 3 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucagon-like peptide 1
Incremental area under curve 0-360 minutes
Measured: 0-360 minutes
Secondary outcomes (19)
Plasma glucagon-like peptide 1
Difference in plasma concentration between interventions
Measured: 0-360 minutes
Gastric inhibitory polypeptide
Difference in plasma concentration between interventions
Measured: 0-360 minutes
C-peptide
Difference in plasma concentration between interventions
Measured: 0-360 minutes
Glucagon
Difference in plasma concentration between interventions
Measured: 0-360 minutes
N-acyl taurine species
Difference in plasma concentration between interventions
Measured: 0-360 minutes
Glucose
Difference in plasma concentration between interventions
Measured: 0-360 minutes
Visual analogue scale
Visual analogue scales are 10 cm long lines. Participants will score their subjective perception of their hunger, satiety, thirst, nausea and well-being from 0 cm (none/bad) to 10 cm (the most amount/good).
Measured: 0-360 minutes
Food intake
Amount of provided meal consumed
Measured: After 360 minutes
Paracetamol (gastric emptying)
Difference in plasma concentration between interventions
Measured: 180-360 minutes
Other glucose-regulating hormones/gut hormones
Difference in plasma concentration between interventions
Measured: 0-360 minutes
Free fatty acids
Difference in plasma concentration between interventions
Measured: 0-360 minutes
Cholesterol
Difference in plasma concentration between interventions
Measured: 0-360 minutes
Bile acids
Difference in plasma concentration between interventions
Measured: 0-360 minutes
Cholecystokinin
Difference in plasma concentration between interventions
Measured: 0-360 minutes
Amino acids
Difference in plasma concentration between interventions
Measured: 0-360 minutes
Gallbladder emptying
Gallbladder volume assessed by ultrasonography
Measured: 0-360 minutes
Fatty acid amide hydrolase genotype
Nucleobase sequence of the fatty acid amide hydrolase gene region of the DNA.
Measured: Baseline
G-protein coupled receptor 119 genotype
Nucleobase sequence of the G-protein coupled receptor 119 gene region of the DNA.
Measured: Baseline
Triglyceride
Difference in plasma concentration between interventions
Measured: 0-360 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study startJun 2027 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic ConditionsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Asger Lund, MD, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771166
- Sponsor's protocol ID
- H-26033426
- Acronym
- NAT-INC
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of N-Acyl Taurines on Incretin Levels in Healthy Subjects: a Randomised, Double-blind, Placebo-controlled, Cross-over Study
- ClinicalTrials.gov ID
- NCT07771166
- Acronym / sponsor ID
- NAT-INC / H-26033426
- Conditions
- Cardiometabolic Conditions
- Keywords
- Glucagon-like peptide 1, N-acyl taurine, GPR119
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Jun 2027 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Aug 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.
This study is an investigator-initiated, randomised, double-blind, placebo-controlled, cross-over human trial investigating the effect of arachidonoyl-taurine (C20:4-taurine) and oleoyl-taurine (C18:1-taurine) on GLP-1 secretion during fasting and feeding.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vehicle | Placebo comparator | Other: Placebo: First dose at 0 hours, Other: Liquid meal and second dose of placebo at 3 hours |
| ARA-T | Experimental | Other: Arachidonoyl-taurine: First dose at 0 hours, Other: Liquid meal and second dose of ARA-T at 3 hours |
| OLE-T | Experimental | Other: Oleoyl-taurine: First dose at 0 hours, Other: Liquid meal and second dose of OLE-T at 3 hours |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 45 years
- Body mass index between 18.5-27 kg/m2
- Informed consent
- Weight stable in the past 3 months
Key exclusion criteria (11 listed)
- Regular tobacco smoking or use of other nicotine-containing products
- Allergy or intolerance to ingredients included in the test compounds or standardised meals
- Glycated haemoglobin (HbA1c) >48 mmol/mol
- Anaemia (haemoglobin below 8.3 mmol/L)
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >2 times upper normal values (Normal values: ALT < 70 U/L, AST <45 U/L)
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 |
|---|---|---|
| Placebo: First dose at 0 hoursVehicle (ultrapure water with 10 % fish sauce), orally administered | Other | Vehicle |
| Arachidonoyl-taurine: First dose at 0 hoursArachidonoyl-taurine (2 mg/kg) dissolved in ultrapure water with 10 % fish sauce, orally administered | Other | ARA-T |
| Oleoyl-taurine: First dose at 0 hoursOleoyl-taurine (2 mg/kg) dissolved in ultrapure water with 10 % fish sauce, orally administered | Other | OLE-T |
| Liquid meal and second dose of placebo at 3 hoursLiquid meal with 1.5 g paracetamol. Administered with a second dose of: Vehicle (ultrapure water with 10 % fish sauce), orally administered | Other | Vehicle |
| Liquid meal and second dose of OLE-T at 3 hoursLiquid meal with 1.5 g paracetamol. Administered with a second dose of: Oleoyl-taurine (2 mg/kg) dissolved in ultrapure water with 10 % fish sauce, orally administered | Other | OLE-T |
| Liquid meal and second dose of ARA-T at 3 hoursLiquid meal with 1.5 g paracetamol. Administered with a second dose of: Arachidonoyl-taurine (2 mg/kg) dissolved in ultrapure water with 10 % fish sauce, orally administered | Other | ARA-T |
Primary outcome
Plasma glucagon-like peptide 1
Time frame: 0-360 minutes
Incremental area under curve 0-360 minutes
19 secondary outcomes
Plasma glucagon-like peptide 1
Time frame: 0-360 minutes
Gastric inhibitory polypeptide
Time frame: 0-360 minutes
C-peptide
Time frame: 0-360 minutes
Glucagon
Time frame: 0-360 minutes
N-acyl taurine species
Time frame: 0-360 minutes
Glucose
Time frame: 0-360 minutes
Visual analogue scale
Time frame: 0-360 minutes
Food intake
Time frame: After 360 minutes
Paracetamol (gastric emptying)
Time frame: 180-360 minutes
Other glucose-regulating hormones/gut hormones
Time frame: 0-360 minutes
Free fatty acids
Time frame: 0-360 minutes
Cholesterol
Time frame: 0-360 minutes
Bile acids
Time frame: 0-360 minutes
Cholecystokinin
Time frame: 0-360 minutes
Amino acids
Time frame: 0-360 minutes
Gallbladder emptying
Time frame: 0-360 minutes
Fatty acid amide hydrolase genotype
Time frame: Baseline
G-protein coupled receptor 119 genotype
Time frame: Baseline
Triglyceride
Time frame: 0-360 minutes
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 18 Aug 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Arachidonoyl-taurine: First dose at 0 hours, Oleoyl-taurine: First dose at 0 hours and Liquid meal and second dose of OLE-T at 3 hours in people with Cardiometabolic Conditions, run by University Hospital, Gentofte, Copenhagen.
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 4 inclusion and 11 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: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma glucagon-like peptide 1 (time frame: 0-360 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 18 Aug 2026.