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New Non-invasive Biomarkers of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)

NCT06647095 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 172

Last updated 2024-11-01

No results posted yet for this study

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)

Conditions

  • Healthy
  • Simple Steatosis (SS)
  • Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
  • Metabolic Dysfunction-associated Steatohepatitis (MASH)

Interventions

DIETARY_SUPPLEMENT

D-Limonene Gelcaps

Capsules containing d-Limonene will be optionally given during the breath test to all participants of all groups

DIETARY_SUPPLEMENT

Fish Oil Concentrate, 1000 Mg Oral Capsule

Capsules containing fish oil will be optionally given during the breath test to all participants of all groups

Sponsors & Collaborators

  • General University Hospital, Prague

    lead OTHER

Principal Investigators

  • Barbora Nováková, MD · General University Hospital, Prague

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-09-01
Completion
2024-09-01

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06647095 on ClinicalTrials.gov