NCT06539494

Luminal Fructose Kinetics (MARTINI Study)

Luminal Fructose Kinetics (MARTINI) (2024)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

In this study the investigators aim is to explore the dynamics of (small) intestinal fructose catabolism in humans and ethanol production in relation to small intestinal signalling pathways and changes in pH, using 13C fructose isotope tracing techniques complemented with direct luminal sampling via small intestinal catheter in biopsy proven MASLD/MASH patients vs healthy (BMI\<25) subjects. Additionally the investigators will repeat the experiment after four weeks of administering omeprazole at a dose of 40 mg twice daily. Omeprazole is a proton pump inhibitor, known to elevate pH from 2-6.

Detailed description

The investigators will perform a non blinded single centre intervention study in 2x 11 participants Participants will be either healthy volunteers with a BMI \< 25 and Age 18-65 or patients with MASLD with a BMI \>25, Age 18-65 The objective of the investigators is to study the fructose host/microbial kinetics in humans and to establish the role of (small) intestinal pH on fructose fermentation and endogenous ethanol production in a MASLD/MASH population versus healthy subjects Subjects will be given omeprazole orally given twice a day 40mg for four weeks At baseline and after four weeks of omeprazole, a fructose challenge test with labelled fructose and fomepizole and a gastroscopy will be performed, during which a nasal-intestinal catheter will be placed to allow for luminal sampling during the fructose challenge test.

Conditions

• MASLD

Interventions

Type	Name	Description
DRUG	Omeprazole 40 MG	Proton pump inhibitor twice a day for 4 weeks

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-01-01
• Completion: 2026-04-01
• First posted: 2024-08-06
• Last updated: 2024-08-06

Locations

1 site across 1 country: Netherlands