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Can a supplement melt liver fat? a trial puts it to the test

NCT ID NCT07724067

Disease control Sponsor: University of Bari Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This trial is testing whether a special supplement containing silibin, glutathione, and vitamin E can reduce fat buildup in the liver and improve liver function in people with MASLD (a common fatty liver disease linked to metabolism). Over 42 adults, each person will take the supplement for three months and a placebo for three months, with a one-month break in between. The study uses ultrasound and a breath test to measure changes in liver fat and function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a dietary supplement containing silibin-enriched silymarin, reduced glutathione, and vitamin E, delivered using Enterosoma technology to improve absorption
What this could lead to
If effective, this supplement could offer a simple, non-drug option to reduce liver fat and improve liver function in people with MASLD.
What could go wrong
This is a small, early-stage trial with only 42 participants. The supplement may show no benefit over placebo, and results may not apply to everyone with MASLD.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

42 people

The number who actually took part.

Started

May 2024

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Evidence of hepatic steatosis (≥ grade 1) at screening. * Body mass index (BMI) ≥25 kg/m² or presence of metabolic dysfunction consistent with MASLD diagnostic criteria. * Stable body weight (no significant weight change during the 3 months preceding enrollment). * Willingness to maintain usual dietary habits, physical activity, and concomitant medications throughout the study. * Ability to provide written informed consent. Exclusion Criteria: * Excessive alcohol consumption (\>30 g/day for men or \>20 g/day for women). Other known causes of chronic liver disease, including viral hepatitis (HBV or HCV), autoimmune liver disease, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, or drug-induced liver disease. * Evidence of liver cirrhosis, hepatic decompensation, hepatocellular carcinoma, or other severe liver disorders. * Previous bariatric surgery or planned bariatric surgery during the study period. * Current use of medications or nutritional supplements known to significantly affect hepatic steatosis or liver function unless on a stable dose for at least 3 months before enrollment. * Pregnancy or breastfeeding. * Severe renal, cardiovascular, respiratory, endocrine, or malignant disease that could interfere with study participation. * Known allergy or hypersensitivity to silybin, glutathione, vitamin E, or any component of the study product. * Any condition that, in the investigator's judgment, could compromise participant safety or adherence to the study protocol

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Conditions

The condition(s) this trial relates to.

fatty liver disease metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Masld (metabolic dysfunction-associated steatotic liver disease)

Contacts and locations

Locations

  • University of Bari

    Bari, 70124, Italy

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