NCT07478588

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

Impacto de la Dieta Mediterránea Frente a la Dieta hipocalórica en la progresión de la Enfermedad hepática y el Riesgo Cardiovascular en Pacientes Con Enfermedad Hepática Metabólica Grasa. Búsqueda de Biomarcadores y Dianas terapéuticas

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This randomized controlled trial included adults with histologically confirmed metabolic dysfunction-associated steatotic liver disease (MASLD) recruited between June 2022 and February 2023 at two tertiary referral centres in Spain (Virgen del Rocío University Hospital, Seville, and University Hospital of Valladolid). Exclusion criteria included 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, and use of steatogenic or investigational drugs. At the screening visit, all patients received counselling to follow a Mediterranean diet enriched with extra virgin olive oil. Participants were then randomized 1:1 to a structured physical activity programme (exercise group) or to a control group receiving standard lifestyle recommendations during a 12-week active intervention period. Randomization was performed using a computer-generated sequence with concealed allocation. This was followed by a further 12-week observation phase without supervised intervention, with a total follow-up period of 24 weeks, designed to reflect real-life clinical practice. The sample size was calculated based on the primary endpoint of steatosis improvement. Assuming an absolute difference of 30% between groups, with a two-sided α level of 0.05 and 80% power, a minimum of 36 patients per group was required. To account for an anticipated dropout rate of 20%, the target sample size was increased to 45 patients per group. The study protocol was approved by the local ethics committees of both centres, and all participants provided written informed consent. The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines.

Conditions

• MASLD

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-02-23
• Completion: 2024-04-03
• First posted: 2026-03-17
• Last updated: 2026-03-19

Locations

2 sites across 1 country: Spain