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

NCT07478588 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-03-19

No results posted yet for this study

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.

Conditions

  • MASLD

Interventions

BEHAVIORAL

Exercise plus Mediterranean diet

Supervised exercise programme consisting of moderate-intensity aerobic activity and resistance training three times per week at a sports centre, plus counselling to follow a Mediterranean diet enriched with extra virgin olive oil.

BEHAVIORAL

At-home exercise plus Mediterranean diet

Moderate-intensity physical activity at home according to EASL recommendations, plus counselling to follow a Mediterranean diet enriched with extra virgin olive oil.

Sponsors & Collaborators

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Principal Investigators

  • Manuel Romero-Gómez · Hospital Universitario Virgen del Rocío de Sevilla

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-02-23
Completion
2024-04-03

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07478588 on ClinicalTrials.gov