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Ketogenic Diet in MASLD-related cACLD
Sponsor: University of Palermo
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-11
Completion Date
2026-11
Last Updated
2024-08-05
Healthy Volunteers
No
Interventions
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.
Locations (1)
Section of Gastroenterology, PROMISE, University of Palermo
Palermo, Italy