MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseFonteESSEMASLDNCT07211113
Effects of Long-lasting Bicarbonate-Sulfate-Calcium-Magnesium Water Intake on Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)-Related Outcome
A study testing Fonte Essenziale® mineral water in people with MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
- What is being tested?
- Fonte Essenziale® mineral water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteItaly
- Study dates
- 29 Jan 2023to 2 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring 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.
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.
Read the 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 designed and implemented under the framework of the Ferrarelle-Vanvitelli research agreement (n. 390-01583577-30059 - dated 09/02/2023), which previously enabled the investigation of mineral water as a non-pharmacological intervention in chronic liver disease.
Patients meeting the diagnostic criteria for MASLD [17] will be consecutively screened for potential eligibility. All individuals considered potentially eligible will undergo Transient Elastography (TE) with Liver Stiffness Measurement (LSM) to exclude those with LSM-defined advanced fibrosis (AF) (> F3).
Eligible participants will then be randomized in a 1:1 ratio into two study arms: Group A and Group B. Group A will receive 400 ml/day of Fonte Essenziale® mineral water, administered each morning on an empty stomach for 12 consecutive months, in addition to a specialist-prescribed controlled nutritional regimen (see dedicated subsection), followed by a 6-month washout period during which only the nutritional regimen will be maintained. Group B will follow the same 12-month nutritional protocol without water supplementation. The selected water dose and fasting administration will be based on the original protocol and prior studies, given that gastric emptying is accelerated and absorption more consistent under fasting conditions, potentially enhancing mucosal interaction.
Three study time-points will be defined: baseline (T0), after 12 months (T12), and post-washout (T18), the latter applicable only to Group A. At each time-point, anthropometric, clinical, and demographic data-including age, sex, smoking status, MASLD-related comorbidities, and Body Mass Index (BMI)-will be collected, alongside routine biochemical parameters and TE-derived liver disease progression metrics, including both LSM-defined fibrosis staging and Controlled Attenuation Parameter (CAP)-based steatosis grading. At T12, a ≥30% reduction in baseline CAP values will be considered indicative of steatosis improvement.
Additionally, at each time-point, following the collection of 20 ml serum and 200 mg fecal samples, intestinal permeability (IP) will be assessed via a biomarker panel comprising fecal zonulin (ng/ml), serum LPS-binding protein (LBPp) (µg/ml), indicative of systemic endotoxin exposure, and serum occludin and claudin-1 (ng/ml), representing epithelial tight-junction integrity. At T0, concurrent fecal zonulin >110 ng/ml and serum LBPp >10 µg/ml will define increased IP (in-IP) [6,13]. At T12, improvement in IP (im-IP) will be defined by simultaneous reductions in fecal zonulin <110 ng/ml and serum LBPp <10 µg/ml. This dual-marker approach will be adopted to enhance diagnostic reliability, as single biomarkers may inadequately reflect barrier integrity and function.
IP-associated systemic inflammation (SI) will be evaluated at all time-points by measuring circulating LPS (ng/ml) and pro-inflammatory cytokines [interleukin (IL)-1β, IL-6, and Tumor Necrosis Factor alpha (TNF-α), pg/ml]. Finally, systemic oxidative stress will be assessed using the Biological Antioxidant Potential (BAP) and derivatives of Reactive Oxygen Metabolites (dROM) tests, both validated tools in chronic liver disease contexts.
- Being tested
- Fonte Essenziale® mineral water
- Keywords
- Intestinal permeability, MASLD, Systemic inflammation, Mineral water, Oxidative stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fonte Essenziale® mineral waterDietary supplement
Also called Bicarbonate-Sulfate-Calcium-Magnesium Water
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: After the 12 months of intervention
Secondary outcomes (2)
Impacting on altered Intestinal Permeability-related systemic inflammation
Improving systemic chronic inflammation status in group A compared with group B , as well as in patients of group A presenting improved IP, compared with those not reaching this outcome
Secondary End-point:
Statistically significant reduction of IL-1, TNF-a, IL-6, LPS serum levels in group A (compared with group B), as well as in patients of group A presenting improved IP, compared with those not reaching this outcome
Measured: T0-T12 (after the 12 months of intervention)
Impacting on clinical outcomes
Improving hepatic steatosis severity and metabolic features in group A compared with group B, as well as in patients of group A presenting improved IP, compared with those not reaching this outcome
End-point: Statistically significant reduction of CAP levels in group A (compared with group B), as well as in patients of group A presenting improved IP, compared with those not reaching this outcome
End-point: Statistically significant reduction of FPG, insulin, TG levels, and increase in HDL serum levels in group A (compared with group B), as well as in patients of group A presenting improved IP, compared with those not reaching this outcome
Measured: T0-T12 (after 12 months-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start29 Jan 2023
- Primary completion25 May 2025
- Study completion2 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Federico, University of Campania Luigi Vanvitelli
- Investigators
- Alessandro Federico, Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211113
- Sponsor's protocol ID
- 0001933/i/2023
- Acronym
- FonteESSEMASLD
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41228524
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring 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.
- ClinicalTrials.gov ID
- NCT07211113
- Acronym / sponsor ID
- FonteESSEMASLD / 0001933/i/2023
- Keywords
- Intestinal permeability, MASLD, Systemic inflammation, Mineral water, Oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 29 Jan 2023 (actual)
- Primary completion
- 25 May 2025 (actual)
- Study completion
- 2 Sep 2025 (actual)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 designed and implemented under the framework of the Ferrarelle-Vanvitelli research agreement (n. 390-01583577-30059 - dated 09/02/2023), which previously enabled the investigation of mineral water as a non-pharmacological intervention in chronic liver disease.
Patients meeting the diagnostic criteria for MASLD [17] will be consecutively screened for potential eligibility. All individuals considered potentially eligible will undergo Transient Elastography (TE) with Liver Stiffness Measurement (LSM) to exclude those with LSM-defined advanced fibrosis (AF) (> F3).
Eligible participants will then be randomized in a 1:1 ratio into two study arms: Group A and Group B. Group A will receive 400 ml/day of Fonte Essenziale® mineral water, administered each morning on an empty stomach for 12 consecutive months, in addition to a specialist-prescribed controlled nutritional regimen (see dedicated subsection), followed by a 6-month washout period during which only the nutritional regimen will be maintained. Group B will follow the same 12-month nutritional protocol without water supplementation. The selected water dose and fasting administration will be based on the original protocol and prior studies, given that gastric emptying is accelerated and absorption more consistent under fasting conditions, potentially enhancing mucosal interaction.
Three study time-points will be defined: baseline (T0), after 12 months (T12), and post-washout (T18), the latter applicable only to Group A. At each time-point, anthropometric, clinical, and demographic data-including age, sex, smoking status, MASLD-related comorbidities, and Body Mass Index (BMI)-will be collected, alongside routine biochemical parameters and TE-derived liver disease progression metrics, including both LSM-defined fibrosis staging and Controlled Attenuation Parameter (CAP)-based steatosis grading. At T12, a ≥30% reduction in baseline CAP values will be considered indicative of steatosis improvement.
Additionally, at each time-point, following the collection of 20 ml serum and 200 mg fecal samples, intestinal permeability (IP) will be assessed via a biomarker panel comprising fecal zonulin (ng/ml), serum LPS-binding protein (LBPp) (µg/ml), indicative of systemic endotoxin exposure, and serum occludin and claudin-1 (ng/ml), representing epithelial tight-junction integrity. At T0, concurrent fecal zonulin >110 ng/ml and serum LBPp >10 µg/ml will define increased IP (in-IP) [6,13]. At T12, improvement in IP (im-IP) will be defined by simultaneous reductions in fecal zonulin <110 ng/ml and serum LBPp <10 µg/ml. This dual-marker approach will be adopted to enhance diagnostic reliability, as single biomarkers may inadequately reflect barrier integrity and function.
IP-associated systemic inflammation (SI) will be evaluated at all time-points by measuring circulating LPS (ng/ml) and pro-inflammatory cytokines [interleukin (IL)-1β, IL-6, and Tumor Necrosis Factor alpha (TNF-α), pg/ml]. Finally, systemic oxidative stress will be assessed using the Biological Antioxidant Potential (BAP) and derivatives of Reactive Oxygen Metabolites (dROM) tests, both validated tools in chronic liver disease contexts.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Dietary Supplement: Fonte Essenziale® mineral water400 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 |
| Group B | No intervention | –Patients receiving the same (of Group A) specialist-prescribed controlled nutritional regimen without water supplementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fonte Essenziale® mineral waterAlso: Bicarbonate-Sulfate-Calcium-Magnesium Water400 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 | Dietary supplement | Group A |
Primary outcome
Intestinal permeability changes
Time frame: T0-T12 (after the 12 months of intervention)
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).
Impacting on intestinal permeability
Time frame: After the 12 months of intervention
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).
2 secondary outcomes
Impacting on altered Intestinal Permeability-related systemic inflammation
Time frame: T0-T12 (after the 12 months of intervention)
Impacting on clinical outcomes
Time frame: T0-T12 (after 12 months-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Derived from this study: PubMed 41228524Dallio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro Federico principal investigator
University of Campania Luigi Vanvitelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fonte Essenziale® mineral water in people with MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intestinal permeability changes (time frame: T0-T12 (after the 12 months of intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07211113, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.