The Role of Very Low Calorie Ketogenic Diet (VLCKD) in Patients Affected by Non-Alcoholic Steatohepatitis (NASH) With Significant Fibrosis (KETONASH)

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna
RECRUITING
Bologna
Contact Information
Primary
Fabio Piscaglia, MD, PhD, Professor
fabio.piscaglia@unibo.it
0512142214
Backup
Federico Ravaioli, MD, PhD
f.ravaioli@unibo.it
+393333176759
Time Frame
Start Date: 2021-09-29
Estimated Completion Date: 2026-12-12
Participants
Target number of participants: 42
Treatments
Experimental: VLCKD arm
The VLCKD dietary intervention consists of five phases:~Ketogenic Low-Calorie Period (2 months):~* Phase 1 (30 days - Visits 1-3): Ketogenic diet with low-fat content, 600 kcal/day.~* Phase 2 (15 days - Visit 5): 660 kcal/day.~* Phase 3 (15 days - Visit 5): 730 kcal/day~Low-Calorie Period (2 months):~Phase 4 (30 days - Visits 6-7): Hypocaloric diet with the reintroduction of different foods, 1,050 kcal/day.~\- Phase 5 (30 days - Visits 7-8): 1,400 kcal/day.~During these phases, the patient will receive nutritional supplementation with vitamins, trace elements, and omega-3 fatty acids. Throughout the very low-calorie ketogenic period, the patient will have three interim dietetic consultations (Visits 2-4) and a medical visit (Visit 5). During the low-calorie period, the patient will receive alternating two dietetic consultations (Visits 6 and 7) and one medical visit every 30 days (Visit 8).
Active_comparator: Control LCD arm
The control LCD arm consists of a diet with natural low-calorie foods (1200-1500 kcal/day or a reduction of 500-1000 kcal/day compared to baseline) and a low glycemic index based on the Mediterranean Diet model, following the most recent guidelines on MAFLD/NAFLD. Similar to the VLCKD arm, for the entire duration of the dietetic treatment, the patient will alternately receive dietetic consultations and medical visits.~At the end of the dietary intervention, patients from both study arms will continue with a controlled, low glycemic index diet tailored to the patient's basal metabolic rate (BMR) (estimated with bioimpedance assessment) for an additional six months.~Both study arms will follow a physical activity schedule and will have psychological-motivational support.
Sponsors
Leads: University of Bologna

This content was sourced from clinicaltrials.gov