CompletedNot Applicable

Structured Physical Activity Intervention in Patients With MASLD Receiving a Mediterranean Diet

Spain96 participantsStarted 2022-06-01

Plain-language summary

Lifestyle interventions based on diet and physical activity are the cornerstone of management for metabolic dysfunction-associated steatotic liver disease (MASLD), yet individual responses remain highly variable. Advanced imaging biomarkers and genetic profiling may help to characterize response patterns. This study aimed to evaluate the impact of a Mediterranean diet-based lifestyle intervention, with or without structured physical activity, on liver steatosis and fibrosis assessed by magnetic resonance imaging, and to identify determinants of treatment response.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults with histologically confirmed metabolic dysfunction-associated steatotic liver disease (MASLD) Exclusion Criteria: * Other causes of chronic liver disease * Excessive alcohol intake (\>20 g/day in women and \>30 g/day in men) * Inability to perform regular physical activity * Current participation in other clinical trials * Use of steatogenic or investigational drugs.

What they're measuring

Steatosis response

Timeframe: From baseline to week 24

Fibrosis regression

Timeframe: Frome baseline to week 24

Trial details

NCT IDNCT07478588

SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-23

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