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Recruiting Not applicable

Role of the Very Low Calorie Ketogenic Diet (VLCKD) in Patients With Non-Alcoholic Steatohepatitis (NASH) With Fibrosis

NCT06308757 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2021-09-29
Last updated
2024-03-15

Condition(s) studied

NASHNAFLDObesityLiver Fibrosis

Investigational drug(s) / intervention(s)

Very-low-calorie ketogenic diet (VLCKD) with meal replacementsMediterranean low-calorie diet (LCD)

Very-low-calorie ketogenic diet (VLCKD) with meal replacements: The VLCKD study arm will receive an experimental diet therapy with very-low-calorie ketogenic meal replacements (VLCKD) consisting of 5 successive phases (600 - 1500 kcal/day).

Mediterranean low-calorie diet (LCD): The Control arm LCD will receive standard Mediterranean type low-calorie diet (LCD) therapy by the most recent guidelines on MAFLD/NAFLD (1200-1500 kcal/day).

Study summary

The purpose of the KETONASH study is to evaluate, in patients with metabolic-associated fatty liver disease (MAFLD) with non-alcoholic steatohepatitis (NASH) and significant liver fibrosis, the effect of a very low-calorie ketogenic diet (VLCKD) compared to that of a standard low-calorie diet (standard Mediterranean LCD - in accordance with the European Association for the Study of the Liver/European Society for Clinical Nutrition and Metabolism guidelines on MAFLD/NAFLD).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients aged ≥18 years with histological diagnosis of NASH with evidence of fibrosis (defined according to NASH CRN) obtained no more than 6 months before enrollment; * Stable weight for more than 6 months with BMI between 30-40 kg/m2; * Patients in whom it is safe and feasible to proceed with liver biopsy and who consent to undergo liver biopsy after 12 months of enrollment to assess the effect of dietary treatment; * Obtained informed consent. Exclusion Criteria: * BMI \<30 or BMI \>40 * Presence of evolved chronic liver disease into cirrhosis (histological F4 or elastometric LSM \>14 kPa) * Type 1 diabetes mellitus * Model for End-stage Liver Disease (MELD) score \>12, AST or ALT ≥5× ULN, HbA1c \>9.5%, INR ≥1.4, creatinine \>1.5 mg/dl, platelets \<100,000/mm3, and total bilirubin \>1.5 mg/dl. * Concurrent presence of any other known chronic liver disease beyond MAFLD/NAFLD, such as alcoholic liver disease, viral (HCV/HBV), cholestatic-autoimmune (PBC/PSC/AIH), Wilson's disease, hemochromatosis, drug-induced liver injury (DILI), or the presence or suspicion of hepatocellular carcinoma (HCC); * Average alcohol consumption exceeding 4/2 units/day (males/females) in the preceding 6 months and a history of excessive alcohol consumption in the last 5 years; * Previous or planned liver transplant, bariatric surgery, ileal resection, or biliary diversion; * History of acute cholecystitis and biliary obstructions (cholangitis); * Recent (in the last 12 months) or concurrent use of agents known to cause hepatic steatosis (long-term systemic corticosteroids \[\>10 days\], amiodarone, methotrexate, tamoxifen, tetracyclines, high-dose estrogens, valproic acid); * Recent (in the last 3 months) change in the dose/regimen or introduction of Vitamin E (at doses ≥400 IU/day), ursodeoxycholic acid (UDCA), betaine, S-adenosyl methionine, silymarin, or pentoxifylline; * Presence of psychiatric disorders and/or diagnosis of any eating disorder; * Life expectancy \<6 months.

Primary outcome measure(s)

  • Change of at least one grade of liver fibrosis — 12 months
    Histological change of liver fibrosis without worsening of NASH
  • Change of histological features of NASH — 12 months
    NASH parameters variation. Improvement in disease activity is defined as decrease in NAFLD Activity Score (NAS) ≥1 points. The worsening of fibrosis is defined as any numerical increase in the stage.

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Italy Recruiting
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 NCT06308757 on ClinicalTrials.gov ↗ ← All trials in Italy