A Nutrigenetic Intervention in MASLD

Not Applicable

Active, not recruiting

• Conditions: Fatty Liver; NAFLD

• Registration Number: NCT06220695
• Lead Sponsor: Maastricht University

Brief Summary

The study is designed as a 12-week randomized controlled dietary intervention in individuals who had been diagnosed with NAFLD in the last 6 months and whose body mass index is above 25 at the time of participation in the pre-screening. The study sample is determined as 150 subjects and randomization will be done by stratification according to PNPLA3 genotype. At baseline, hepatic steatosis and fibrosis will be measured with Fibroscan, body composition will be analyzed, and transaminases and sugar and lipid metabolism indicators will be examined. The study will be conducted in parallel groups, with each group receiving equal amounts and intensity of Mediterranean diet or low-fat diet therapy. At the end of the 12-week intervention, baseline measurements will be repeated and the efficacy of the Mediterranean Diet and Low-fat diet therapies will be compared, as well as the effect of PNPLA3 mutation on intrahepatic response will be analyzed.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-19
• Study First Submitted: 2024-01-15
• Study First Submitted QC: 2024-01-15
• Study First Posted: 2024-01-24
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-15
• Primary Completion: 2024-10-18
• Study Completion: 2024-10-18

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Able to understand and sign informed consent
• BMI> 25 kg/m2
• Between 18-80 years
• previous clinical diagnosis of MASLD by abdominal USG, MRI, FibroScan® or liver biopsy

Exclusion Criteria

• Excessive alcohol use (more than 20 g/day for women and 30g/day for men= >2 units alcohol/day for women and >3 units for men)
• Other liver diseases: Hepatitis B virus, Hepatitis C virus, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, Alpha 1 antitrypsin deficiency
• Secondary causes for steatosis: disorders of lipid metabolism, HCV Genotype 3, total parental nutrition, severe surgical weight loss, medications (amiodarone, tamoxifen, methotrexate, corticosteroids and HAART)
• Celiac disease
• pregnancy and breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Decrease in CAP (db/m)	12 weeks	The primary objective of this study is to determine the percentage decrease in hepatic steatosis at the end of week 12, measured by FibroScan® with CAP
Decrease in Liver Stiffness (kPa)	12 weeks	The primary objective of this study is to determine the percentage decrease in hepatic fibrosis at the end of week 12, measured by FibroScan® with E

Trial Locations

Locations (1)

Istanbul University Cerrahpasa Hospital; 🇹🇷 Istanbul, Turkey