Overall design: The study will include one intervention based on Mediterranean diet plus structured lifestyle intervention (150 min/week of moderate-intensity or 75 min/week of high-intensity exercise) for a total of 16 weeks. Following a screening period of up to 12 months, eligible participants will be included in a single cohort.
Study details include:
* Study duration will be up to 36 months including the screening period. * Intervention will be up to 16 weeks. * Visit frequency will be every 4 weeks for the interventional period and every 12 weeks during follow-up.
Metabolic disarrangements following ATPIII criteria (i.e. comorbidities such as Type 2 diabetes, central obesity, BMI≥>25 kg/m2, hypertension, dyslipidaemia.
Written informed consent
No dietetical counsellor/weight loss higher than 10% within the prior 6 months
Age over 18 years old
Significant alcohol intake (≥30 g/day in men and ≥20 g/day in women)
Other causes of liver disease (evidence of viral or autoimmune hepatitis, HIV, drug-induced fatty liver or other metabolic liver diseases)
Use of recreational drugs
Decompensated acute or chronic liver disease
Single group
Multimodal lifestyle intervention
BehavioralMediterranean diet plus structured lifestyle intervention (150 min/week of moderate-intensity or 75 min/week of high-intensity exercise) for a total of 16 weeks.
Number of Participants Achieving a Steatosis Response
Defined as a 30% decrease in MRI-Proton Density Fat Fraction (PDFF) and CAP assessed by Transient Elastography
Number of Participants Achieving Fibrosis Regression
\>20% reduction in liver stiffness measured by MRE.
Change From Baseline in Metabolic Dysfunction-Associated Steatohepatitis Resolution Index Score
Change from baseline to Month 16 in the Metabolic Dysfunction-Associated Steatohepatitis Resolution Index (MASH Resolution Index; MASH-RI), a composite non-invasive score developed to estimate resolution of steatohepatitis. The MASH-RI is calculated as: 0.520-0.003×baseline ALT (U/L)-0.024×(latest ALT (U/L)-baseline ALT (U/L))-0.048×baseline MRI-PDFF-2.571×(\[latest MRI-PDFF-baseline MRI-PDFF\]/baseline MRI-PDFF)-0.039×baseline AST (U/L). A MASH-RI ≥-0.67 rules in MASH resolution, and a MASH-RI of ≤-2.67 rules out a resolution.
% Change in Weight
Weight measured in kilograms
% Change in Waist Circumference
Waist Circumference measured in centimeters
Change in Patient Reported Physical Activity
Assessment of patient reported physical activity using the International Physical Activity Questionnaire (IPAQ). IPAQ classifies individuals into five categories based on their total Metabolic Equivalent of Task (MET) minutes per week. Low physical activity: Less than 600 MET-minutes/week; moderate physical activity: Between 600 and 3,000 MET-minutes/week; or high physical activity: More than 3,000 MET-minute/week
Change in Patient Reported Diet Habits by MEDAS Questionnaire
Assessment of patient reported diet habits using the MEDAS questionnaire, a 14-item questionnaire of Mediterranean Diet adherence. Score lower than 9 means low adherence to Mediterranean Diet, and score equal or higher that 9 means good adherence to Mediterranean Diet.
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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Lead sponsor
Instituto de Salud Carlos III
Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborator
Hacettepe University
Collaborator
Consorcio Centro de Investigación Biomédica en Red (CIBER)
Collaborator
