MASLDEHMet-DIANCT07478588
Structured Physical Activity Intervention in Patients With MASLD Receiving a Mediterranean Diet
A study testing Exercise plus Mediterranean diet and At-home exercise plus Mediterranean diet in people with MASLD, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MASLD
- What is being tested?
- Exercise plus Mediterranean diet and At-home exercise plus Mediterranean diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jun 2022to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with histologically confirmed metabolic dysfunction-associated steatotic liver disease (MASLD)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario Virgen del Rocío de Sevilla
Seville
Hospital Universitario de Valladolid
Valladolid
About this study
Official title: 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
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.
Read the 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
- Being tested
- Exercise plus Mediterranean diet, At-home exercise plus Mediterranean diet
- Keywords
- MASLD, Lifestyle intervention, Liver steatosis, MASH, Metabolic dysfuction-associated steatotic liver disease, Physical activity, Exercise, Mediterranean diet, Magnetic resonance imaging, Proton density fat fraction, Genetic
- Medical subject headings
- Fatty Liver, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise plus Mediterranean dietBehavioural
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.
At-home exercise plus Mediterranean dietBehavioural
Moderate-intensity physical activity at home according to EASL recommendations, plus counselling to follow a Mediterranean diet enriched with extra virgin olive oil.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Supervised exercise programme consisting of moderate-intensity aerobic activity and resistance training three times per week at a sports centre. Receives: 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 Receives: Behavioral: At-home exercise plus Mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steatosis response
Defined as a ≥30% reduction in MRI-proton density fat fraction (PDFF) from baseline to week 24
Measured: From baseline to week 24
Fibrosis regression
≥20% reduction in liver stiffness measured by MRE or improvement of at least one fibrosis stage
Measured: Frome baseline to week 24
Secondary outcomes (15)
% Change in Weight
Weight measured in kilograms
Measured: From baseline to week 24
% Change in Waist Circumference
Waist circumference measured in centimeters
Measured: From baseline to week 24
% Change in Fat Mass
Fat mass measured in % by impedanciometry
Measured: From baseline to week 24
% Change in Muscle Mass
Muscle mass measured in % by impedanciometry
Measured: From baseline to week 24
% Change in Fasting Triglycerides
Triglycerides measured in mg/dL in blood test
Measured: From baseline to week 24
% Change in Fasting Aspartate Transaminase
Aspartate transaminase measured in U/L in blood test
Measured: From baseline to week 24
% Change in Fasting Alanine Transaminase
Alanine transaminase measured in U/L in blood test
Measured: From baseline to week 24
% Change in Fasting Glycosylated Haemoglobin
Glycosylated haemoglobin measured in % in blood test
Measured: From baseline to week 24
Change in Patient Reported Diet Habits by MEDAS Questionnaire
Assessment of patient reported diet habits using the MEDAS questionnaire, a validated 14-item questionnaire of Mediterranean Diet adherence. Score lower than 9 means low adherence to Mediterranean Diet, and score equal or higher than 9 means good adherence to Mediterranean Diet.
Measured: From baseline to week 24
Change in Patient Reported Diet Habits by Dietary Items Recount
Assessment of patient reported diet habits using the Dietary Items Recount survey (units/week), that quantifies average consumption of specific foods or beverages over a seven-day period.
Measured: From baseline to week 24
Change in Exercise Tolerance
Assessment of exercise tolerance and functional capacity using the 6-minute walk test (6MWT). The 6MWT is a functional, submaximal exercise test that measures the maximum distance in meters a person can walk at fastest speed on a flat, hard surface in 6 minutes.
Measured: From baseline to week 24
Change in Patient Reported Physical Activity
Assessment of patient reported physical activity using the International Physical Activity Questionnaire (IPAQ) questionnaire. IPAQ classifies individuals into three categories based on their total Metabolic Equivalent of Task (MET) minutes per week. Low physical activity: Less than 600 MET-minutes/week; moderate physical activity: Between 600 and 3,000 MET-minutes/week; or high physical activity: More than 3,000 MET-minutes/week.
Measured: From baseline to week 24
Change in Patient Reported Individual Functioning
Assessment of individual functioning using the SF-12 questionnaire, a 12-item, patient-reported, validated questionnaire assessing Health-Related Quality of Life (HRQoL) across eight physical and mental domains. It covers physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health.
Measured: From baseline to week 24
Change in Patient Reported Quality of Life
Assessment of patient reported quality of life using the CLDQ-NAFLD Questionnaire, a 36-item, validated, disease-specific questionnaire that assesses patient reported outcomes over the past two weeks across six domains: abdominal symptoms, activity/energy, emotional health, fatigue, systemic symptoms, and worry.
Measured: From baseline to week 24
Genetic Analysis
Rate of patients (in %) carrying different polymorphisms. The genotyping of the single nucleotide polymorphisms (SNP) of interest, PNPLA3 rs738409, HSD17B13 rs72613567, TM6SF2 rs58542926, FUT2 rs601338, MBOAT7 rs641738 and GCKR rs1260326, was performed using TaqMan SNP genotyping assays and chemistries (ThermoFisher, USA).
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Jun 2022
- Primary completion1 Sep 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MASLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuel Romero-Gómez, Principal investigator, Hospital Universitario Virgen del Rocío de Sevilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478588
- Sponsor's protocol ID
- EHMet-DIA
- Other IDs
- P20_01075
- Acronym
- EHMet-DIA
- Status last verified
- Jan 2026
- First submitted
- 4 Mar 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07478588
- Acronym / sponsor ID
- EHMet-DIA / EHMet-DIA
- Conditions
- MASLD
- Keywords
- MASLD, Lifestyle intervention, Liver steatosis, MASH, Metabolic dysfuction-associated steatotic liver disease, Physical activity, Exercise, Mediterranean diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise plus Mediterranean dietSupervised exercise programme consisting of moderate-intensity aerobic activity and resistance training three times per week at a sports centre. |
| Control | Active comparator | Behavioral: At-home exercise plus Mediterranean dietThe control group was advised to perform moderate-intensity physical activity at home according to EASL recommendations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with histologically confirmed metabolic dysfunction-associated steatotic liver disease (MASLD)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise plus Mediterranean dietSupervised 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. | Behavioural | Exercise |
| At-home exercise plus Mediterranean dietModerate-intensity physical activity at home according to EASL recommendations, plus counselling to follow a Mediterranean diet enriched with extra virgin olive oil. | Behavioural | Control |
Primary outcome
Steatosis response
Time frame: From baseline to week 24
Defined as a ≥30% reduction in MRI-proton density fat fraction (PDFF) from baseline to week 24
Fibrosis regression
Time frame: Frome baseline to week 24
≥20% reduction in liver stiffness measured by MRE or improvement of at least one fibrosis stage
15 secondary outcomes
% Change in Weight
Time frame: From baseline to week 24
% Change in Waist Circumference
Time frame: From baseline to week 24
% Change in Fat Mass
Time frame: From baseline to week 24
% Change in Muscle Mass
Time frame: From baseline to week 24
% Change in Fasting Triglycerides
Time frame: From baseline to week 24
% Change in Fasting Aspartate Transaminase
Time frame: From baseline to week 24
% Change in Fasting Alanine Transaminase
Time frame: From baseline to week 24
% Change in Fasting Glycosylated Haemoglobin
Time frame: From baseline to week 24
Change in Patient Reported Diet Habits by MEDAS Questionnaire
Time frame: From baseline to week 24
Change in Patient Reported Diet Habits by Dietary Items Recount
Time frame: From baseline to week 24
Change in Exercise Tolerance
Time frame: From baseline to week 24
Change in Patient Reported Physical Activity
Time frame: From baseline to week 24
Change in Patient Reported Individual Functioning
Time frame: From baseline to week 24
Change in Patient Reported Quality of Life
Time frame: From baseline to week 24
Genetic Analysis
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
Related trials for MASLD
RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
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Recruiting
Exercise for an Aging Liver (EXALIVER)
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, MASH - Metabolic Dysfunction-Associated Steatohepatitis
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
RecruitingObservational study
Clinical Profile of Patients With MASLD in Kazakhstan and Clinical Effectiveness of Ursosan in Almaty
Metabolic Dysfunction-Associated Steatotic Liver Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Romero-Gómez principal investigator
Hospital Universitario Virgen del Rocío de Sevilla
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise plus Mediterranean diet and At-home exercise plus Mediterranean diet in people with MASLD, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steatosis response (time frame: From baseline to week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.