Ketogenic Diet Versus Mediterranean Diet in Adults With Fatty Liver Cirrhosis

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with compensated advanced chronic liver disease caused by metabolic fatty liver disease (MASLD). It compares a very low calorie ketogenic diet with a Mediterranean diet.

Age

Older than 18 years.

Sex

All sexes can join.

Disease stage

Compensated advanced chronic liver disease (cACLD) due to MASLD: liver stiffness of 10 KPa or more on Transient Elastography, and/or fibrosis F3 or F4 on liver biopsy. MASLD means fatty liver plus at least one of five cardiometabolic risk factors.

Earlier treatment

Cannot have started SGLT-2 inhibitors or GLP-1 agonists within 6 months of screening. Cannot have used drugs known to cause fatty liver (such as corticosteroids, amiodarone, methotrexate, tamoxifen, tetracycline, high dose estrogens, valproic acid) within 6 months or now. No past or planned gastrointestinal bypass or other bariatric surgery.

Biomarker or test result

Liver stiffness of 10 KPa or more on Transient Elastography, and/or fibrosis F3 or F4 on liver biopsy.

Main reasons for not taking part

• Any other chronic liver disease
• Alcohol intake in the MetALD range (140-350 g/wk for females, 210-420 g/wk for males)
• Decompensated cirrhosis, liver cancer or portal thrombosis
• Pregnant or breastfeeding
• Weight loss of more than 5 % in the past 6 months

The registry criteria, word for word

What the trial wants to find out

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.

The 2 groups in the trial

• Mediterranean DietExisting treatment, for comparison

  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 DietTreatment being tested

  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.