A Nutrigenetic Intervention in MASLD

NAFLD Clinical Trial

Official title:

Efficacy of Isocaloric Mediterranean Diet and Low-fat Diet in Overweight/Obese MASLD Subjects With Respect to PNPLA3 Single Nucleotide Polymorphism: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06220695
• Other study ID #: UMCRPS-23-1
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 19, 2023
• Est. completion date: October 18, 2024

Study information

• Verified date: April 2024
• Source: Maastricht University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: October 18, 2024
• Est. primary completion date: October 18, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• NAFLD

Intervention

Behavioral:
• Dietary intervention
The dietary intervention is a personalized counselling programme implemented in form of a moderate caloric restriction (˜500 kcal/day) to allow for a moderate weight loss (˜5% BW). Each participant will be invited for consultation visits to a study dietitian, lasting up to 30 minutes. During the sessions, participants will be provided with written information material that explains the principles of diet in concern. Dietary interventions for both groups will be standardized in terms of education and one-on-one counseling. Education and dietary prescription will be individualized by the study dietitians within the diet-specific recommendations, to allow for personal food preferences. All subjects will receive equivalent intensity of care in terms of opportunities for contact and availability of individual dietary counseling. Motivational interviewing techniques and behavior change techniques will be adopted by study dietitians to ensure long-term maintenance of dietary modification.

Locations

Country	Name	City	State
Turkey	Istanbul University Cerrahpasa Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University	Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in CAP (db/m)	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	12 weeks
Primary	Decrease in Liver Stiffness (kPa)	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	12 weeks