Ketogenic Diet in MASLD-related cACLD

NCT06537466 | Not Yet Recruiting

• 1 other identifier: KETOMASH
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that very low ketogenic diet could represent a new therapeutic option in the management of patients with MASLD and cACLD. Therefore, the investigator propose a randomized controlled study that evaluates the impact of two dietary protocols -Mediterranean diet, and very low ketogenic diet- the MD and the VLCKD, in individuals with cACLD secondary to MASLD.

Conditions

Steatohepatitis, Nonalcoholic; Steatosis of Liver; Cirrhosis, Liver

Keywords

Steatohepatitis; Steatosis; Ketogenic diet

Outcome Measures

Primary Outcomes (1)

• weight loss≥10% compared to the initial weight in individuals with cACLD secondary to MASLD

  Weight in Kg

  48 weeks

Secondary Outcomes (15)

• ▪ changes in liver stiffness by Magnetic Resonance Elastography (MRE)

  48 weeks

• ▪ changes in liver fat by Magnetic Resonance Imaging-proton density fat fraction (MRI-PDFF)

  48 weeks

• ▪ changes in liver stiffness by transient elastography

  48 weeks

• ▪ changes in liver fat by controlled attenuation parameter (CAP)

  48 weeks

• ▪ changes in Spleen stiffness by Magnetic Resonance Elastography (MRE)

  48 weeks

Study Arms (2)

Mediterranean Diet

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.

Dietary Supplement: Mediterranean diet

Very Low Ketogenic Diet

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.

Dietary Supplement: Very Low Ketogenic Diet

Interventions

Mediterranean diet DIETARY_SUPPLEMENT

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.

Mediterranean Diet

Very Low Ketogenic Diet DIETARY_SUPPLEMENT

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.

Very Low Ketogenic Diet

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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\&lt;1:160 and AMA negativity); autoimmune hepatitis (ANA, SMA and LKM \&lt;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 ( \&gt; 5 % within previous 6 months)
• Presence of large esophageal varices (F2 or F3)
• Decompensated liver cirrhosis and/or presence of hepatocarcinoma and/or portal thrombosis.
• Be pregnant or breasxeeding.
• Type 1 diabetes, cardiac arrhythmias, recent stroke or myocardial infarction, heart failure, elective surgery or invasive procedures, chronic kidney disease (eGFR\&lt;30 ml/min).
• Therapy with SGLT-2 inhibitors and/or GLP-1 agonist started within 6 months of screening visit.
• Recent (within 6 months of screening visit) or concomitant use of agents known to cause hepatic steatosis (corticosteroids, amiodarone, methotrexate, tamoxifen, tetracycline, high dose estrogens, valproic acid)
• Any additional condition that might interfere with optimal participation in the study, according to investigators opinion

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

Section of Gastroenterology, PROMISE, University of Palermo

Palermo, Italy

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver; Liver Cirrhosis

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Gastroenterology, MD, PhD

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: August 5, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)