NCT Number: NCT07478588
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.
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All sexes
Interventional
Not applicable
Hospital Universitario Virgen del Rocío de Sevilla, Seville, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Moderate-intensity physical activity at home according to EASL recommendations, plus counselling to follow a Mediterranean diet enriched with extra virgin olive oil.
Time frame: From baseline to week 24
Defined as a ≥30% reduction in MRI-proton density fat fraction (PDFF) from baseline to week 24
Time frame: Frome baseline to week 24
≥20% reduction in liver stiffness measured by MRE or improvement of at least one fibrosis stage
Time frame: From baseline to week 24
Weight measured in kilograms
Time frame: From baseline to week 24
Waist circumference measured in centimeters
Time frame: From baseline to week 24
Fat mass measured in % by impedanciometry
Time frame: From baseline to week 24
Muscle mass measured in % by impedanciometry
Time frame: From baseline to week 24
Triglycerides measured in mg/dL in blood test
Time frame: From baseline to week 24
Aspartate transaminase measured in U/L in blood test
Time frame: From baseline to week 24
Alanine transaminase measured in U/L in blood test
Time frame: From baseline to week 24
Glycosylated haemoglobin measured in % in blood test
Time frame: From baseline to week 24
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.
Time frame: From baseline to week 24
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.
Time frame: From baseline to week 24
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.
Time frame: From baseline to week 24
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.
Time frame: From baseline to week 24
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.
Time frame: From baseline to week 24
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.
Time frame: At baseline
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).
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Other
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
Acronym: EHMet-DIA
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