New Non-invasive Biomarkers of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) (NCT06647095) | Clinical Trial Compass
CompletedNot Applicable
New Non-invasive Biomarkers of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
Czechia172 participantsStarted 2021-09-01
Plain-language summary
The goal of this observational study is to learn if some components of blood or exhaled breath can diagnose people having more fat in their livers than is normal, because of their poorer metabolic health (for example, because of obesity and diabetes). The main questions it aims to answer are:
1. Can a method find participants with higher liver fat than healthy participants?
2. Can a method find participants in whom higher liver fat was a cause of liver inflammation or stiffness?
Participants will:
* fast overnight
* have a routine blood draw
* easily exhale a few times into a special device or a plastic bag and fill in a short dietary questionnaire (if participating in a breath test)
* optionally swallow capsules with an orange peel extract and fish oil before exhaling, which can help get better results from breath (capsules will be medically safe and approved)
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for Participants with MASLD:
* Presence of liver steatosis (detected either by hepatic ultrasonography/CAP/histologically) or MASH/simple steatosis confirmed by liver biopsy
* Absence of secondary causes of fat accumulation in the liver and other liver disease: ruled out other etiologies of liver disease, such as viral hepatitis, drug-induced liver disease, autoimmune liver disease, biliary tract disease, and hereditary metabolic diseases
Inclusion Criteria for Negative Controls:
* Absence of liver disease
* For breath analysis: absence of liver steatosis (normal liver ultrasound image and CAP less than 248 dB/m)
* For plasma spectroscopy and bile acid analysis: Body Mass Index ≤ 25 and waist-hip ratio ≤ 0.95 plus normal liver ultrasound
* Absence of diabetes mellitus and metabolic syndrome
* Normal liver function tests, lipid spectrum, fasting glycemia
* Alcohol intake less than 20 g/ day (women) or 30 g/ day (men)
Exclusion Criteria:
* Non-compliance with the investigation program
* Failure to sign the informed consent form
* Liver biopsy/clinic discrepancy
* For LMN a TMA "stress test": fish, see fruit and citrus fruit allergy
* Pregnancy
* For bile acid analysis: Treatment with BA or BA sequestrants
* For bile acid analysis: Portal hypertension (does not apply for MASH patients)
* For bile acid analysis: Cirrhosis (does not apply for MASH patients)
* For plasma spectroscopy: Cirrhosis
* Anamnesis of alcohol abuse (based on GGT, carbohydrate-deficie…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Serum bile acids concentrations in the MASH/ Steatosis/ Healthy controls
Timeframe: A single day during within the data collection period = between September 2021 and September 2024
2
The effect of serum bile acids in the MASH/ Steatosis/ Healthy controls discrimination
Timeframe: A single day during within the data collection period = between September 2021 to September 2024
3
Native breath concentrations of volatile organic compounds in the aim groups
Timeframe: Single measurement on one day within 6 weeks (from mid-February 2023 to the end of March 2023)
4
A change in d-Limonene and TMA concentrations before and after the ingestion of capsules containing d-LMN, TMA, ppbv
Timeframe: Baseline, at 150min after capsules ingestion - both on one day within 6 weeks (from mid-February 2023 to the end of March 2023)
5
The effect of concentrations of volatile organic compounds in exhaled breath, native and post-ingestion, on the discrimination of the aim groups
Timeframe: On one day within 6 weeks (from mid-February 2023 to the end of March 2023)
6
Peak of d-LMN, and TMA concentration after the ingestion of capsules in the aim groups
Timeframe: At an individually specific time point for each participant that occurs within 4 hours after ingestion of d-Limonene and TMA-containing capsules on a single day within 6 weeks (from mid-February 2023 to the end of March 2023)
7
Spectroscopic patterns of blood plasma
Timeframe: Based on single peripheral blood uptake within the data collection period = between September 2021 and September 2024