NCT06537466Not yet recruiting
Ketogenic Diet in MASLD-related cACLD
A 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)
Source: ClinicalTrials.gov · Last updated 5 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 25 Jul 2024
- Start date
- Nov 2024
- Primary completion date
- Nov 2026
- Lead sponsor
- University of Palermo
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06537466
What you commit to
- Study type: Interventional
- Planned participants: 50
- From Nov 2024 to the primary completion date, Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent significant weight loss ( \> 5 % within previous 6 months)
- 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)
Other illness
- 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.
- Decompensated liver cirrhosis and/or presence of hepatocarcinoma and/or portal thrombosis.
- Any additional condition that might interfere with optimal participation in the study, according to investigators opinion
Lab values
- 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), . .
- Type 1 diabetes, cardiac arrhythmias, recent stroke or myocardial infarction, heart failure, elective surgery or invasive procedures, chronic kidney disease (eGFR\<30 ml/min).
Other
- Presence of large esophageal varices (F2 or F3)
- Be pregnant or breasxeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Section of Gastroenterology, PROMISE, University of Palermo Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.