Amsterdam UMC location AMC
Amsterdam, Netherlands
Location status: Recruiting
NCT Number: NCT06539494
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 2
Amsterdam, Netherlands
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
In case of the healthy subject group:
Exclusion criteria
Proton pump inhibitor twice a day for 4 weeks
Time frame: four weeks
mM (serum, intestinal fluid, urine and feces)
Time frame: 4 weeks
Area under the curve of fructose in peripheral blood upon ingestion of 1 gram / kg unlabeled fructose in combination with 1000mg of D-fructose-13C6 measured during fructose challange test
Time frame: 4 weeks
Area under the curve of various metabolites (e.g. ethanol) will be measured in breath samples upon ingestion of 1 gram / kg unlabeled fructose in combination with 1000mg of D-fructose-13C6 measured during fructose challange test
Time frame: 4 weeks
Using 24h feces, the investigators will measure fecal concentrations of fructose metabolites such as ethanol, as well as short chain fatty acids (SCFAs) and bile acids.
Time frame: 4 weeks
Using 24h urine, the investigators will measure fecal concentrations of fructose metabolites such as ethanol, as well as SCFAs and bile acids.
Time frame: 4 weeks
mmol/l measured during fructose challange test
Time frame: four weeks
changes in relative abundance (%) of bacterial phyla, genera and species between groups and after intervention with omeprazol measured by 16sRNA sequencing and shotgun metagenome analysis
Time frame: four weeks
Participants are asked to fill out an online dietary questionnaire for the 3 days prior to study visits
Time frame: four weeks
Using specific anaerobic culturing, ethanol production of fecal samples will be assessed of bacterial strains.
Time frame: four weeks
changes in relative abundance (%) of bacterial phyla, genera and species between groups and after intervention with omeprazol measured by 16sRNA sequencing.
Time frame: 4 weeks
measured by RNA sequencing
Time frame: 4 weeks
changes in relative abundance (%) of bacterial phyla, genera and species between groups and after intervention with omeprazol measured by 16sRNA sequencing and shotgun metagenome analysis
Time frame: 4 weeks
Postprandial plasma samples will be prepared for the analysis of mainly: organic acids, amino acids, fatty acids, uric acid, glucose and fructose before and after intervention with omeprazol
Contact information is provided by the study sponsor or research team.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Other
Luminal Fructose Kinetics (MARTINI) (2024)
Acronym: MARTINI
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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