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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity Hospital, Gentofte, Copenhagen

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age between 18 and 45 years

Body mass index between 18.5-27 kg/m2

Informed consent

Weight stable in the past 3 months

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Placebo: First dose at 0 hours

    Other intervention

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

  • Arachidonoyl-taurine: First dose at 0 hours

    Other intervention

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

  • Oleoyl-taurine: First dose at 0 hours

    Other intervention

    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 intervention

    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 intervention

    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 intervention

    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

Treatment groups

18 Participants
are divided into 3 treatment groups
Group A: VehiclePlacebo comparator 2 interventions
Group B: ARA-TExperimental treatment 2 interventions
Group C: OLE-TExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Plasma glucagon-like peptide 1

Incremental area under curve 0-360 minutes

Time frame
0-360 minutes

Secondary outcomes

1

Plasma glucagon-like peptide 1

Difference in plasma concentration between interventions

Time frame
0-360 minutes
2

Gastric inhibitory polypeptide

Difference in plasma concentration between interventions

Time frame
0-360 minutes
3

C-peptide

Difference in plasma concentration between interventions

Time frame
0-360 minutes
4

Glucagon

Difference in plasma concentration between interventions

Time frame
0-360 minutes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Gentofte, Copenhagen

Lead sponsor

University of Copenhagen

Collaborator

This trial is not recruiting at the moment. You can still explore other options: