NCT06308757 Role of the Very Low Calorie Ketogenic Diet (VLCKD) in Patients With Non-Alcoholic Steatohepatitis (NASH) With Fibrosis
| NCT ID | NCT06308757 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Bologna |
| Condition | NASH |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2021-09-29 |
| Primary Completion | 2024-11-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 42 participants in total. It began in 2021-09-29 with a primary completion date of 2024-11-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Fabio Piscaglia
PRINCIPAL INVESTIGATOR
University of Bologna
Frequently Asked Questions
Who can join the NCT06308757 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying NASH. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06308757 currently recruiting?
Yes, NCT06308757 is actively recruiting participants. Contact the research team at fabio.piscaglia@unibo.it for enrollment information.
Where is the NCT06308757 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06308757 clinical trial?
NCT06308757 is sponsored by University of Bologna. The principal investigator is Fabio Piscaglia at University of Bologna. The trial plans to enroll 42 participants.