Status:
ACTIVE_NOT_RECRUITING
A Nutrigenetic Intervention in MASLD
Lead Sponsor:
Maastricht University
Collaborating Sponsors:
Istanbul University - Cerrahpasa
Conditions:
NAFLD
Fatty Liver
Eligibility:
All Genders
18-80 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06220695
Start Date
October 19 2023
End Date
October 18 2024
Last Update
April 15 2024
Active Locations (1)
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1
Istanbul University Cerrahpasa Hospital
Istanbul, Turkey (Türkiye)