Status:
COMPLETED
Effects of Long-lasting Bicarbonate-Sulfate-Calcium-Magnesium Water Intake on Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)-Related Outcome
Lead Sponsor:
University of Campania Luigi Vanvitelli
Conditions:
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background: Fonte Essenziale®, a mineral water rich in bicarbonate, sulphate, calcium, and magnesium, has shown potential in modulating the gut-liver axis and microbiota in hepatic steatosis. However,...
Detailed Description
This will be a prospective, randomized, controlled clinical trial conducted at the Hepatogastroenterology Division of the University of Campania "Luigi Vanvitelli" (Naples, Italy). The study will be d...
Eligibility Criteria
Inclusion
- The inclusion criteria were: age \> 18 years, imaging ultrasound-based evidence of hepatic steatosis, and clinical and biochemical features configuring MD (at least one of: obesity, type 2 diabetes, dyslipidemia, or essential arterial hypertension diagnosis).
- All patients who were potentially considered eligible received TE evaluation with the LSM definition. Importantly, patients with AF (TE-assessed LSM confirming \>F3) were excluded. This choice was motivated by evidence that in AF, IP is significantly altered, contributing to an enhanced bacterial translocation, both events influenced by the potential presence of portal hypertension Other exclusion criteria were: (a) chronic liver disease (CLD) of other etiology \[hepatitis B and/or C virus, alcohol-related liver disorder (ALD) with evidence of alcohol abuse history assessed by using the Alcohol Use Disorders Identification Test questionnaire, hemochromatosis, Wilson's disease, or cholestatic liver disorders\]; (b) evidence of cancer, including hepatocellular carcinoma (HCC); (c) acute systemic infections; (d) pregnancy; (e) psychological/psychiatric problems potentially invalidating the informed consent and/or conditions impacting the ability to adhere to dietary recommendations and intervention protocol; (f) chronic kidney disease (with Estimated Glomerular Filtration Rate - eGFR- \<30 ml/min); (g) the use (ongoing and/or in the 3 months preceding the enrollment) of drugs/supplements that could influence IP (e.g., probiotics, antibiotics, NSAIDs).
Exclusion
Key Trial Info
Start Date :
January 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 2 2025
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT07211113
Start Date
January 29 2023
End Date
September 2 2025
Last Update
October 7 2025
Active Locations (1)
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1
University of Campania Luigi Vanvitelli
Napoli, Campania, Italy, 80138