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

NARecruitingINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

September 29, 2021

Primary Completion Date

November 24, 2024

Study Completion Date

December 12, 2026

Conditions
NASHNAFLDObesityLiver Fibrosis
Interventions
DIETARY_SUPPLEMENT

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).

DIETARY_SUPPLEMENT

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).

Trial Locations (1)

40138

RECRUITING

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna

All Listed Sponsors
lead

University of Bologna

OTHER