NCT07478588

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2024

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
Last Updated

March 19, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

March 4, 2026

Last Update Submit

March 17, 2026

Conditions

MASLD

Keywords

MASLDLifestyle interventionLiver steatosisMASHMetabolic dysfuction-associated steatotic liver diseasePhysical activityExerciseMediterranean dietMagnetic resonance imagingProton density fat fractionGenetic

Outcome Measures

Primary Outcomes (2)

  • Steatosis response

    Defined as a ≥30% reduction in MRI-proton density fat fraction (PDFF) from baseline to week 24

    From baseline to week 24

  • Fibrosis regression

    ≥20% reduction in liver stiffness measured by MRE or improvement of at least one fibrosis stage

    Frome baseline to week 24

Secondary Outcomes (15)

  • % Change in Weight

    From baseline to week 24

  • % Change in Waist Circumference

    From baseline to week 24

  • % Change in Fat Mass

    From baseline to week 24

  • % Change in Muscle Mass

    From baseline to week 24

  • % Change in Fasting Triglycerides

    From baseline to week 24

  • +10 more secondary outcomes

Study Arms (2)

Exercise

EXPERIMENTAL

Supervised exercise programme consisting of moderate-intensity aerobic activity and resistance training three times per week at a sports centre.

Behavioral: Exercise plus Mediterranean diet

Control

ACTIVE COMPARATOR

The control group was advised to perform moderate-intensity physical activity at home according to EASL recommendations

Behavioral: At-home exercise plus Mediterranean diet

Interventions

Exercise plus Mediterranean dietBEHAVIORAL

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.

Exercise
At-home exercise plus Mediterranean dietBEHAVIORAL

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

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with histologically confirmed metabolic dysfunction-associated steatotic liver disease (MASLD)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario Virgen del Rocío de Sevilla

Seville, Spain

Location

Hospital Universitario de Valladolid

Valladolid, Spain

Location

MeSH Terms

Conditions

Fatty LiverMotor Activity

Interventions

ExerciseDiet, Mediterranean

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaDiet, Plant-BasedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Manuel Romero-Gómez

    Hospital Universitario Virgen del Rocío de Sevilla

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 17, 2026

Study Start

June 1, 2022

Primary Completion

February 23, 2023

Study Completion

April 3, 2024

Last Updated

March 19, 2026

Record last verified: 2026-01

Locations

ES(2)