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NCT Number: NCT07771166

Effects of N-Acyl Taurines on Incretin Levels in Healthy Subjects

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 45 years
  • Body mass index between 18.5-27 kg/m2
  • Informed consent
  • Weight stable in the past 3 months

Exclusion criteria

  • 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))
  • 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

Treatment and study plan

Placebo: First dose at 0 hours

Other

Vehicle (ultrapure water with 10 % fish sauce), orally administered

Arachidonoyl-taurine: First dose at 0 hours

Other

Arachidonoyl-taurine (2 mg/kg) dissolved in ultrapure water with 10 % fish sauce, orally administered

Oleoyl-taurine: First dose at 0 hours

Other

Oleoyl-taurine (2 mg/kg) dissolved in ultrapure water with 10 % fish sauce, orally administered

Liquid meal and second dose of placebo at 3 hours

Other

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 hours

Other

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 hours

Other

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

Primary outcomes

  1. Plasma glucagon-like peptide 1

    Time frame: 0-360 minutes

    Incremental area under curve 0-360 minutes

Secondary outcomes

  1. Plasma glucagon-like peptide 1

    Time frame: 0-360 minutes

    Difference in plasma concentration between interventions

  2. Gastric inhibitory polypeptide

    Time frame: 0-360 minutes

    Difference in plasma concentration between interventions

  3. C-peptide

    Time frame: 0-360 minutes

    Difference in plasma concentration between interventions

  4. Glucagon

    Time frame: 0-360 minutes

    Difference in plasma concentration between interventions

  5. N-acyl taurine species

    Time frame: 0-360 minutes

    Difference in plasma concentration between interventions

  6. Glucose

    Time frame: 0-360 minutes

    Difference in plasma concentration between interventions

  7. Visual analogue scale

    Time frame: 0-360 minutes

    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).

  8. Food intake

    Time frame: After 360 minutes

    Amount of provided meal consumed

  9. Paracetamol (gastric emptying)

    Time frame: 180-360 minutes

    Difference in plasma concentration between interventions

  10. Other glucose-regulating hormones/gut hormones

    Time frame: 0-360 minutes

    Difference in plasma concentration between interventions

  11. Free fatty acids

    Time frame: 0-360 minutes

    Difference in plasma concentration between interventions

  12. Cholesterol

    Time frame: 0-360 minutes

    Difference in plasma concentration between interventions

  13. Bile acids

    Time frame: 0-360 minutes

    Difference in plasma concentration between interventions

  14. Cholecystokinin

    Time frame: 0-360 minutes

    Difference in plasma concentration between interventions

  15. Amino acids

    Time frame: 0-360 minutes

    Difference in plasma concentration between interventions

  16. Gallbladder emptying

    Time frame: 0-360 minutes

    Gallbladder volume assessed by ultrasonography

  17. Fatty acid amide hydrolase genotype

    Time frame: Baseline

    Nucleobase sequence of the fatty acid amide hydrolase gene region of the DNA.

  18. G-protein coupled receptor 119 genotype

    Time frame: Baseline

    Nucleobase sequence of the G-protein coupled receptor 119 gene region of the DNA.

  19. Triglyceride

    Time frame: 0-360 minutes

    Difference in plasma concentration between interventions

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

Effects of N-Acyl Taurines on Incretin Levels in Healthy Subjects: a Randomised, Double-blind, Placebo-controlled, Cross-over Study

Acronym: NAT-INC

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Aug 18, 2026
Registry last updated
Aug 18, 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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