A new definition for metabolic dysfunction-associated fatty liver disease: An international expert consensus statement.
Mohammed Eslam, Philip N Newsome, Shiv K Sarin...
https://pubmed.ncbi.nlm.nih.gov/32278004Actively Recruiting
Led by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis · Updated on 2026-05-06
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
Metabolic dysfunction-associated steatotic liver disease (MASLD) is a common chronic condition linked to metabolic problems like obesity and diabetes, and it is a leading cause of liver-related illness and death. This research evaluates how consuming extra virgin olive oil (EVOO), a key part of the Mediterranean diet known for its anti-inflammatory and antioxidant properties, affects liver fat, inflammation, and metabolism in adults with MASLD who are overweight or have obesity. The study aims to clarify the optimal amount of EVOO intake for these individuals. Participants will follow a Mediterranean-style diet tailored to their age, sex, and lifestyle, with two different daily amounts of raw EVOO added: either 3 tablespoons (about 30 g) or 9 tablespoons (about 90 g). The study lasts about 74 days, beginning with a 14-day period where all participants consume 3 tablespoons of EVOO to reduce selection bias before being randomly assigned to one of the two dosage groups. EVOO is included as part of their total calorie intake and used raw throughout the day. During the study, participants will attend several visits for assessments including Fibroscan scans to measure liver fat, body measurements, blood tests to check liver enzymes and inflammation markers, and stool and urine samples to study gut microbiota and metabolism. Body weight will be tracked weekly to avoid significant changes that could affect results. The main outcomes measured are changes in liver fat levels, inflammatory cytokines, and liver enzymes after two months of treatment. Secondary outcomes include changes in blood lipid profiles and gut microbiota composition.
CONDITIONS
EVOO and Metabolic Liver Health in MASLD
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants consume a predefined amount of extra virgin olive oil (3 tablespoons per day) for 14 days to reduce selection bias before randomization.
1 visit (in-person) after 14 days for reassessment
Duration - Approximately 74 days
Participants are randomized to consume an isocaloric Mediterranean-style diet with either 3 tablespoons or 9 tablespoons of extra virgin olive oil daily, used raw at any time of day.
3 visits (in-person) during treatment at day 0 (enrollment), day 30, and day 60
Total: 1 location
1
UOS Data Science
Castellana Grotte, Italy, Italy, 70013
Actively Recruiting
R
Rossella Tatoli, Dietician
R
Rossella Donghia, Biologist
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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