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
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