Exploring how fructose is processed in the intestines of patients with MASLD
Luminal Fructose Kinetics (MARTINI) (2024)
This study is testing how the body processes fructose and makes alcohol in the intestines of people with Metabolic Associated Steatotic Liver Disease (MASLD) compared to healthy individuals.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT06539494 on ClinicalTrials.gov |
What this trial studies
This study investigates the metabolism of fructose in the small intestine and its relationship with ethanol production in patients with Metabolic Associated Steatotic Liver Disease (MASLD) compared to healthy individuals. Using 13C fructose isotope tracing and direct luminal sampling via a catheter, the study aims to understand how intestinal pH affects fructose fermentation and ethanol production. Participants will undergo a fructose challenge test before and after a four-week course of omeprazole, a proton pump inhibitor that alters intestinal pH. The study will include 22 participants, divided into healthy volunteers and MASLD patients, aged 18-65.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-65 with biopsy-proven MASLD and a BMI greater than 25, as well as healthy volunteers with a BMI less than 25.
Not a fit: Patients with a history of significant alcohol consumption, diabetes, or other liver diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of MASLD through targeted dietary and pharmacological interventions.
How similar studies have performed: While the specific approach of this study is novel, previous studies have shown the importance of fructose metabolism in liver diseases, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 * Male or postmenopauzal females * BMI \> 25 * Biopsy proven MASLD/MASH * Ability to give informed consent Exclusion Criteria: * 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 * 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
Where this trial is running
Amsterdam
- Amsterdam UMC location AMC — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Max Nieuwdorp, prof — Amsterdam UMC, location AMC
- Study coordinator: Max Nieuwdorp, Prof
- Email: m.nieuwdorp@amsterdamumc.nl
- Phone: 0031 20 5669111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.