MASLDPhase 2MARTININCT06539494
Luminal Fructose Kinetics (MARTINI Study)
A Phase 2 study testing Omeprazole 40 MG in people with MASLD, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- MASLD
- What is being tested?
- Omeprazole 40 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2024to Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In case of the healthy subject group:
- Adult individuals, age > 18 <65 years
- Male or postmenopauzal females
- BMI <25
- Ability to give informed consent In case of the MASLD/MASH group
- Adult individuals, age > 18 <65 years
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- Male or postmenopauzal females
- BMI > 25
- Biopsy proven MASLD/MASH
- Ability to give informed consent
Who cannot join
- 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)
- Proton-pump inhibitor usage one year prior to study participation
- GLP1, SGLT2i or insulin use
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- Antibiotic use for the past 3 months
- Probiotic or symbiotic usage
- Pregnant women
- Chronic illness (including a known history of heart failure, renal failure (eGFR <30 ml/min), pulmonary disease, gastrointestinal disorders, or hematologic diseases), or other inflammatory diseases
- Active infection
- Use of ascal, clopidogrel or other platelet inhibition
- Smoking
- Blood thinners
- Heart failure
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC location AMC
Amsterdam
max nieuwdorp, MD PhD, 0031 20 5669111, m.nieuwdorp@amsterdamumc.nl
About this study
Official title: Luminal Fructose Kinetics (MARTINI) (2024)
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.
Read the 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
- Being tested
- Omeprazole 40 MG
- Keywords
- Fructose, MASLD, Ethanol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omeprazole 40 MGDrug
Proton pump inhibitor twice a day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteer | Active comparator | healthy volunteers who will get omeprazol daily 2dd40 mg for 4 weeks Receives: Drug: Omeprazole 40 MG |
| Sujbects with MASLD | Active comparator | Patients with MASLD who will get omeprazol daily 2dd40 mg for 4 weeks Receives: Drug: Omeprazole 40 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ethanol concentrations before and after omeprazol usage
mM (serum, intestinal fluid, urine and feces)
Measured: four weeks
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
Measured: 4 weeks
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
Measured: 4 weeks
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.
Measured: 4 weeks
Fructose metabolites in urine
Using 24h urine, the investigators will measure fecal concentrations of fructose metabolites such as ethanol, as well as SCFAs and bile acids.
Measured: 4 weeks
Changes in serum glucose concentrations before and after omeprazol
mmol/l measured during fructose challange test
Measured: 4 weeks
Secondary outcomes (7)
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
Measured: four weeks
Changes in dietary intake
Participants are asked to fill out an online dietary questionnaire for the 3 days prior to study visits
Measured: four weeks
Bioreactor analyses
Using specific anaerobic culturing, ethanol production of fecal samples will be assessed of bacterial strains.
Measured: four weeks
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.
Measured: four weeks
Differences in gene expression in small intestinal biopsies
measured by RNA sequencing
Measured: 4 weeks
Changes in Fecal microbiota composition
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
Measured: 4 weeks
Changes in abundance of post prandial plasma metabolites
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Jul 2024
- Primary completionJan 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 2x 11 participants will be given the same intervention (omeprazol daily)
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Nieuwdorp, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Max Nieuwdorp, prof, Principal investigator, Amsterdam UMC, location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539494
- Sponsor's protocol ID
- NL85966.018.23
- Acronym
- MARTINI
- Status last verified
- Aug 2024
- First submitted
- 18 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Luminal Fructose Kinetics (MARTINI) (2024)
- ClinicalTrials.gov ID
- NCT06539494
- Acronym / sponsor ID
- MARTINI / NL85966.018.23
- Conditions
- MASLD
- Keywords
- Fructose, MASLD, Ethanol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2x 11 participants will be given the same intervention (omeprazol daily)
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer | Active comparator | Drug: Omeprazole 40 MGhealthy volunteers who will get omeprazol daily 2dd40 mg for 4 weeks |
| Sujbects with MASLD | Active comparator | Drug: Omeprazole 40 MGPatients with MASLD who will get omeprazol daily 2dd40 mg for 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult individuals, age > 18 <65 years
- Male or postmenopauzal females
- BMI <25
- Ability to give informed consent In case of the MASLD/MASH group
- Adult individuals, age > 18 <65 years
Key exclusion criteria (15 listed)
- 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)
- Proton-pump inhibitor usage one year prior to study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omeprazole 40 MGProton pump inhibitor twice a day for 4 weeks | Drug | Healthy volunteer, Sujbects with MASLD |
Primary outcome
Changes in ethanol concentrations before and after omeprazol usage
Time frame: four weeks
mM (serum, intestinal fluid, urine and feces)
Changes in fructose concentrations in peripheral blood before and after omeprazol usage
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
Changes in fructose metabolites in breath before and after omeprazol usage
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
Fructose metabolites in feces before and after omeprazol usage
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.
Fructose metabolites in urine
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.
Changes in serum glucose concentrations before and after omeprazol
Time frame: 4 weeks
mmol/l measured during fructose challange test
7 secondary outcomes
Changes in microbiota composition in luminal samples
Time frame: four weeks
Changes in dietary intake
Time frame: four weeks
Bioreactor analyses
Time frame: four weeks
Changes in Oral microbiota composition
Time frame: four weeks
Differences in gene expression in small intestinal biopsies
Time frame: 4 weeks
Changes in Fecal microbiota composition
Time frame: 4 weeks
Changes in abundance of post prandial plasma metabolites
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
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Active, not recruitingObservational study
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Qurse Revand for MASLD: A Randomized Controlled Safety and Efficacy Trial
MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
Recruiting
Exercise for an Aging Liver (EXALIVER)
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RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
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RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Max Nieuwdorp, prof principal investigator
Amsterdam UMC, location AMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omeprazole 40 MG in people with MASLD, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Max Nieuwdorp, Prof (0031 20 5669111, m.nieuwdorp@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in ethanol concentrations before and after omeprazol usage (time frame: four weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.