Effects of Long-lasting Bicarbonate-Sulfate-Calcium-Magnesium Water Intake on Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)-Related Outcome

NCT07211113 | Completed DMC

• 1 other identifier: 0001933/i/2023
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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, its long-term effects on intestinal permeability (IP), systemic inflammation (SI), and oxidative stress-key factors in Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) -remain unexplored. MASLD patients will be consecutively endoller and randomized into two groups: group A receiving Fonte Essenziale® (400 ml/day, fasting) plus a controlled nutritional regimen for 12 months, followed by a 6-month water washout; group B followed only the controlled nutritional regimen. IP markers, SI (IL-1β, IL-6, TNF-α), oxidative stress (dROMs/BAP), and clinical data (including Controlled Attenuation Parameter - CAP) will be assessed at baseline (T0), 12 months (T12), and post-washout (T18). Baseline increased IP (in-IP) was defined by fecal zonulin \>110 ng/ml and serum LBPp \>10 µg/ml; improvement (im-IP) required normalization of both. A ≥30% CAP reduction will indicate hepatic steatosis improvement.

Conditions

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Keywords

Intestinal permeability; MASLD; Systemic inflammation; Mineral water; Oxidative stress

Outcome Measures

Primary Outcomes (2)

• Intestinal permeability changes

  Improving increased intestinal permeability (IP) in group A compared with group B Primary End-point (composite): Statistically significant reduction of fecal zonulin, simultaneously with a significant increase occludin and claudin 1 serum levels, in group A (compared with group B) Note: In each patient, the simultaneous reduction of fecal zonulin (\< 110 ng/ml) and serum LPBp (\< 10 microg/ml) defined an improvement in IP (i-IP).

  T0-T12 (after the 12 months of intervention)

• Impacting on intestinal permeability

  Improving increased intestinal permeability (IP) in group A compared with group B Endpoint: Statistically significant reduction of fecal zonulin, simultaneously with a significant increase occludin and claudin 1 serum levels, in group A (compared with group B) Note:In each patient, the simultaneous reduction of fecal zonulin (\< 110 ng/ml) and serum LPBp (\< 10 microg/ml) defined an improvement in IP (i-IP).

  After the 12 months of intervention

Secondary Outcomes (2)

• Impacting on altered Intestinal Permeability-related systemic inflammation

  T0-T12 (after the 12 months of intervention)

• Impacting on clinical outcomes

  T0-T12 (after 12 months-intervention)

Study Arms (2)

Group A

EXPERIMENTAL

400 ml/day of Fonte Essenziale® mineral water, taken every morning on an empty stomach for 12 consecutive months, in addition to a specialist-prescribed controlled nutritional regimen, followed by a 6-month water wash-out period of exclusive controlled nutritional regimen

Dietary Supplement: Fonte Essenziale® mineral water

Group B

NO INTERVENTION

Patients receiving the same (of Group A) specialist-prescribed controlled nutritional regimen without water supplementation

Interventions

Fonte Essenziale® mineral water DIETARY_SUPPLEMENT

400 ml/day of Fonte Essenziale® mineral water, taken every morning on an empty stomach for 12 consecutive months, in addition to a specialist-prescribed controlled nutritional regimen

Also known as: Bicarbonate-Sulfate-Calcium-Magnesium Water

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

University of Campania Luigi Vanvitelli

Napoli, Campania, 80138, Italy

Location

Related Publications (1)

• Dallio M, Romeo M, Di Nardo F, Senese G, Silvestrin A, Coppola A, Napolitano C, Vaia P, Basile C, Martinelli G, Gregorio A, Federico A. Beneficial Effects of Long-Lasting Bicarbonate-Sulfate-Calcium-Magnesium Water Intake on Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)-Related Outcomes via Impacting Intestinal Permeability (IP), IP-Related Systemic Inflammation, and Oxidative Stress. Nutrients. 2025 Oct 31;17(21):3452. doi: 10.3390/nu17213452.

  PMID: 41228524 DERIVED

Study Officials

• Alessandro Federico

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The randomization list was generated using online randomization software (http://www.graphpad.com/quickcalcs/index.cfm) using permuted block list generation (to further reduce sequence predictability). Furthermore, the methods and tools used to generate the sequence were tracked. Regarding allocation concealment, the following criteria were also met: the block size was not disclosed to the investigators enrolling the patients; the investigators recruiting the patients did not know to which group the nex
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: Eligible participants will be randomly assigned in a 1:1 ratio into two study arms: 1) Group A: received 400 ml/day of Fonte Essenziale® mineral water, taken every morning on an empty stomach for 12 consecutive months, in addition to a specialist-prescribed controlled nutritional regimen, followed by a 6-month water wash-out period of exclusive controlled nutritional regimen; 2) Group B: followed the same specialist-prescribed controlled nutritional regimen without water supplementation

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 7, 2025
• Study Start: January 29, 2023
• Primary Completion: May 25, 2025
• Study Completion: September 2, 2025
• Last Updated: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)