NCT07821515

Brief Summary

The study aim is to determine whether acute inhibition of endogenous prostaglandin synthesis by paracetamol affects the release of gut hormones, glucose absorption and glycemia in healthy young individuals

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Jun 2026Dec 2026

Study Start

First participant enrolled

June 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2026

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

September 15, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

September 9, 2026

Last Update Submit

September 9, 2026

Conditions

Healthy Young AdultsPhysiology

Keywords

prostaglandinsglucosegut hormonesParacetamolGLP-1GIPmeal test

Outcome Measures

Primary Outcomes (1)

  • Glucagon-like peptide 1

    Plasma concentration

    From baseline samples (-15, 0 min) until the end of the meal test at t = 180min

Secondary Outcomes (8)

  • Glucose

    From baseline samples (-15, 0 min) until the end of the meal test at t = 180min

  • Gastrin

    From baseline samples (-15, 0 min) until the end of the meal test at t = 180min

  • Cholecystokinin

    From baseline samples (-15, 0 min) until the end of the meal test at t = 180min

  • Glucose-dependent insulinotropic polypeptide (GIP)

    From baseline samples (-15, 0 min) until the end of the meal test at t = 180min

  • C-peptide

    From baseline samples (-15, 0 min) until the end of the meal test at t = 180min

  • +3 more secondary outcomes

Study Arms (2)

Paracetamol (1000mg)

ACTIVE COMPARATOR
Other: Paracetamol

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

ParacetamolOTHER

Paracetamol is used as a tool to block prostaglandin synthesis

Paracetamol (1000mg)
PlaceboOTHER

A placebo will be administered to be able to determine the effect of paracetamol on prostaglandin synthesis

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • BMI of 20-25
  • Written informed consent

You may not qualify if:

  • Haemoglobin \< 7.9 mmol/L
  • Pregnancy or breastfeeding
  • Significant gastrointestinal symptoms (e.g. dyspepsia, postprandial pain)
  • Use of medication that cannot be paused for 12 hours or any drug that affects gastric emptying, small intestinal motility, glucose absorption.
  • Use of paracetamol, NSAID, aspirin or similar within the previous week.
  • Evidence of drug abuse, consumption of tobacco in any form or daily consumption of more than 20g alcohol
  • History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery including cholecystectomy (but not uncomplicated appendicectomy)
  • Participation in other research studies within the previous 3 months
  • Inability to give informed consent
  • Intolerance to any of the components of paracetamol and the meals used for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Biomedical Sciences, The Panum Institute, University of Copenhagen,

Copenhagen, Capital, 2200, Denmark

RECRUITING

Hvidovre Hospital, Copenhagen University Hospital

Hvidovre, 2650, Denmark

RECRUITING

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Simon Veedfald, MD, PhD

    Department of BIomedical Scienes, University Copenhagen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Veedfald, MD, PhD

CONTACT

+45 41102595veedfald@sund.ku.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
identical capsules containing Paracetamol and placebo is prepared by the pharmacy
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomised double blind placebo-controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

September 9, 2026

First Posted

September 15, 2026

Study Start

June 1, 2026

Primary Completion

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 15, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)