Health TrialsbyHealthPanel

Luminal Fructose Kinetics (MARTINI Study)

ConditionMASLD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult individuals, age > 18 <65 years

Male or postmenopauzal females

BMI <25

Ability to give informed consent In case of the MASLD/MASH group

Disqualifiers

History of sustained excess alcohol ingestion: daily consumption >30g/day (3 drinks per day) for males and >20 g/day (2 drinks per day) for females

Patients with diabetes

Bariatric surgery

Other forms of liver disease (e.g. Hepatitis B,C, Wilson disease, hemochromatosis)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Omeprazole 40 MG

    Drug

    Proton pump inhibitor twice a day for 4 weeks

Treatment groups

22 Participants
are divided into 2 treatment groups
Group A: Healthy volunteerActive comparator 1 intervention
Group B: Sujbects with MASLDActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes in ethanol concentrations before and after omeprazol usage

mM (serum, intestinal fluid, urine and feces)

Time frame
four weeks
2

Changes in fructose concentrations in peripheral blood before and after omeprazol usage

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
3

Changes in fructose metabolites in breath before and after omeprazol usage

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
4

Fructose metabolites in feces before and after omeprazol usage

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

Secondary outcomes

1

Changes in microbiota composition in luminal samples

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
2

Changes in dietary intake

Participants are asked to fill out an online dietary questionnaire for the 3 days prior to study visits

Time frame
four weeks
3

Bioreactor analyses

Using specific anaerobic culturing, ethanol production of fecal samples will be assessed of bacterial strains.

Time frame
four weeks
4

Changes in Oral microbiota composition

changes in relative abundance (%) of bacterial phyla, genera and species between groups and after intervention with omeprazol measured by 16sRNA sequencing.

Time frame
four weeks

Other outcomes

Sponsors and contacts

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

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Lead sponsor

Source ClinicalTrials.gov
Apply now