UNMASK: Unveiling the Pathobiology of Metabolic Dysfunction-Associated Steatotic Liver Disease for the Discovery of Novel Therapeutics and Biomarkers

Summary

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.

Eligibility

Inclusion Criteria:

* 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
* Liver stiffness measurement by Fibroscan ≥ 8, CAP ≥ 248 db/m and MRI PDFF ≥ 5%. ,

Exclusion Criteria:

* 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
* Cirrhosis or transplant waitlist
* Pregnancy or parenteral nutrition
* No nutritional interventions, medications for weight loss or weight loss higher than 5% within the last year
* Presence of other comorbidities that would impact lifestyle intervention (i. e. prosthesis)
* Absence of a personal smartphone with a compatible operating system capable of supporting the Amazfit Bip 6 accelerometer app's functionalities: Android 7.0 or iOS 14.0, or later.

Conditions2

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