Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-27 @ 10:45 PM
Study NCT ID:
NCT06220695
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Nutrigenetic Intervention in MASLD
Sponsor:
Maastricht University
Organization:
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: