Recruiting soon

Ketogenic vs. Mediterranean Diet for Advanced Chronic Liver Disease Due to MASLD

What is being tested

Mediterranean diet

+ Very Low Ketogenic Diet

Dietary Supplement

Who is being recruted

Digestive System Diseases+5

+ Fatty Liver

+ Fibrosis

Over 18 Years

+14 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: November 2024

See protocol details

Summary

Principal SponsorUniversity of Palermo

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2024

Actual date on which the first participant was enrolled.

This study focuses on evaluating two different diets to manage weight and liver health in patients with a specific type of liver disease called compensated advanced chronic liver disease, which is related to metabolic issues. The two diets being compared are the Mediterranean diet, known for its balanced approach, and the very low-carbohydrate ketogenic diet (VLCKD), which has gained attention for promoting quick weight loss. The study aims to assess if these diets can help patients achieve significant weight loss and improve liver health, as these patients are at higher risk for liver-related complications and currently have limited treatment options outside of lifestyle changes. Participants in the study will follow one of the two dietary plans for 48 weeks. Those on the Mediterranean diet will consume a balanced intake of carbohydrates, proteins, and fats, while those on the ketogenic diet will follow a low-calorie, low-carbohydrate plan that encourages the body to use fat as an energy source. Progress will be monitored through various health assessments, including body measurements and blood tests, to track changes in liver and metabolic health. Participants will also undergo imaging studies to assess liver condition. The study will help determine the effectiveness of these diets in improving health outcomes for patients with this type of liver disease.

Official TitleA Randomised Controlled Tria of Low-calorie Ketogenic Diet Versus Mediterranean Diet in Patients With Compensated Advanced Chronic Liver Disease (cACLD) Secondary to Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

NCT06537466

Principal SponsorUniversity of Palermo

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesFatty LiverFibrosisLiver CirrhosisLiver DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNon-alcoholic Fatty Liver Disease

Criteria

3 inclusion criteria required to participate

Patients older than 18 years

Pattients with cACLD secondary MASLD. Specifically cACLD is defined as liver stiffness ≥10 KPa by Transient Elastography and/or fibrosis F3 or F4 at liver biopsy by Kleiner scoring system; MASLD is defined by the presence of steatosis and at least one of five cardiometabolic risk factor.

Informed consent form obtained before any trial-related ac.vity.

11 exclusion criteria prevent from participating

Concomitance of any other chronic liver disease: Wilson's disease (normal serum ceruloplasmin); alpha-1-an.trypsin deficiency (normal serum alpha-1-an.trypsin); viral hepatitis (anti-HCV and HBsAg negativity); primary biliary cirrhosis (ANA<1:160 and AMA negativity); autoimmune hepatitis (ANA, SMA and LKM <1:160), . .

MetALD: patients with metabolic dysfunc.on-associated steato.c liver disease, who consume amounts of alcohol per week (140-350 g/wk and 210-420 g/wk for females and males, respectively.

History of or planned gastrointestinal bypass or any additional bariatric surgery/intervention.

Recent significant weight loss ( > 5 % within previous 6 months)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

This equilibrated diet has a caloric value 10% below the total metabolic expenditure of each individual. The total metabolic expenditure is calculated from the basal metabolic expenditure (based on the formula FAO/WHO/UN) multiplied by the coefficient of activity, which is calculated according to the physical activity of each participant. The calories provide to this group range between 1,400 and 1,800 kcal/day. The ration of macronutrients provided is 45-55 % arbohydrates,15-25 % proteins, and 25-35 % fat, in addition to a recommended intake of 20-40 g/day of fiber in the form of vegetables and fruits.

Group II

Experimental

The VLCKD ketogenic protocol entails: a caloric intake \< 800 calories, a protein intake calculated based on individual needs: 1.2 + 0.2 g/kg/ideal body weight, low carbohydrate content (approximately 45-55 g of carbohydrates per day), and low lipids (10-15g/day). Vitamins and minerals, Unlimited vegetables.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Section of Gastroenterology, PROMISE, University of Palermo

Palermo, ItalyOpen Section of Gastroenterology, PROMISE, University of Palermo in Google Maps

Recruiting soonOne Study Center