Ketogenic Diet in MASLD-related cACLD

NCT06537466 · tracked via the Priya Life Science Italy tracker

Sponsor

University of Palermo

Phase

Not applicable

Started

2024-11

Last updated

2024-08-05

Condition(s) studied

Steatohepatitis, NonalcoholicSteatosis of LiverCirrhosis, Liver

Investigational drug(s) / intervention(s)

Mediterranean dietVery Low Ketogenic Diet

Mediterranean diet: 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.

Very Low Ketogenic Diet: 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 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Patients older than 18 years 2. 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. 3. Informed consent form obtained before any trial-related ac.vity. Exclusion Criteria: 1. 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), . . 2. 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. 3. History of or planned gastrointestinal bypass or any additional bariatric surgery/intervention. 4. Recent significant weight loss ( \> 5 % within previous 6 months) 5. Presence of large esophageal varices (F2 or F3) 6. Decompensated liver cirrhosis and/or presence of hepatocarcinoma and/or portal thrombosis. 7. Be pregnant or breasxeeding. 8. Type 1 diabetes, cardiac arrhythmias, recent stroke or myocardial infarction, heart failure, elective surgery or invasive procedures, chronic kidney disease (eGFR\<30 ml/min). 9. Therapy with SGLT-2 inhibitors and/or GLP-1 agonist started within 6 months of screening visit. 10. 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) 11. Any additional condition that might interfere with optimal participation in the study, according to investigators opinion

Primary outcome measure(s)

weight loss≥10% compared to the initial weight in individuals with cACLD secondary to MASLD — 48 weeks
Weight in Kg

Trial sites (1)

Facility	City	Region	Status
Section of Gastroenterology, PROMISE, University of Palermo	Palermo	Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06537466 on ClinicalTrials.gov ↗ ← All trials in Italy