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| ID | Type | Description | Link |
|---|---|---|---|
| EPPERMED2024-496 | Other Grant/Funding Number | ISCIII under the frame of EP PerMed |
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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | OTHER |
| Hacettepe University | OTHER |
| Consorcio Centro de Investigación Biomédica en Red (CIBER) |
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Overall design: The study will include one intervention based on Mediterranean diet plus structured lifestyle intervention (150 min/week of moderate-intensity or 75 min/week of high-intensity exercise) for a total of 16 weeks. Following a screening period of up to 12 months, eligible participants will be included in a single cohort.
Study details include:
The UNMASK trial is a multicenter (Spain, Italy and Turkey), prospective, open-label lifestyle intervention based on tailored caloric restriction and monitored exercise. UNMASK aims to prove that the amelioration of MASLD at systemic and hepatic levels will be parallel to the improvement in our selected biomarkers. Given the known challenges with diagnosis and staging of MASH when using histopathological assessments of liver biopsies, the study will evaluate various blood-based non-invasive biomarkers. Non-invasive tests will be performed to asses endpoints. UNMASK includes a single arm in which patients undergo lifestyle changes, chiefly through the prescription of Mediterranean diet and physical exercise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal lifestyle intervention | Experimental | Mediterranean diet (MD) rich in olive oil, nuts and coffee, combined with structured exercise through a lifestyle intervention (LSI) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal lifestyle intervention | Behavioral | Mediterranean diet plus structured lifestyle intervention (150 min/week of moderate-intensity or 75 min/week of high-intensity exercise) for a total of 16 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving a Steatosis Response | Defined as a 30% decrease in MRI-Proton Density Fat Fraction (PDFF) and CAP assessed by Transient Elastography | From baseline to month 16 |
| Number of Participants Achieving Fibrosis Regression | >20% reduction in liver stiffness measured by MRE. | From baseline to month 16 |
| Change From Baseline in Metabolic Dysfunction-Associated Steatohepatitis Resolution Index Score | Change from baseline to Month 16 in the Metabolic Dysfunction-Associated Steatohepatitis Resolution Index (MASH Resolution Index; MASH-RI), a composite non-invasive score developed to estimate resolution of steatohepatitis. The MASH-RI is calculated as: 0.520-0.003×baseline ALT (U/L)-0.024×(latest ALT (U/L)-baseline ALT (U/L))-0.048×baseline MRI-PDFF-2.571×([latest MRI-PDFF-baseline MRI-PDFF]/baseline MRI-PDFF)-0.039×baseline AST (U/L). A MASH-RI ≥-0.67 rules in MASH resolution, and a MASH-RI of ≤-2.67 rules out a resolution. | From baseline to month 16 |
| Measure | Description | Time Frame |
|---|---|---|
| % Change in Weight | Weight measured in kilograms | From baseline to month 16 |
| % Change in Waist Circumference | Waist Circumference measured in centimeters |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Internal Medicine and Liver Transplantation Unit | Not yet recruiting | Roma | Italy |
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| Label | URL |
|---|---|
| Description of the UNMASK Study within the EP PerMed project database, which currently lists transnational research and innovation projects in personalised medicine funded by EP PerMed | View source |
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| OTHER_GOV |
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| From baseline to month 16 |
| Change in Patient Reported Physical Activity | Assessment of patient reported physical activity using the International Physical Activity Questionnaire (IPAQ). IPAQ classifies individuals into five 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-minute/week | From baseline to month 16 |
| Change in Patient Reported Diet Habits by MEDAS Questionnaire | Assessment of patient reported diet habits using the MEDAS questionnaire, a 14-item questionnaire of Mediterranean Diet adherence. Score lower than 9 means low adherence to Mediterranean Diet, and score equal or higher that 9 means good adherence to Mediterranean Diet. | From baseline to month 16 |
| Hospital Universitario Virgen del Rocío de Sevilla | Recruiting | Seville | Spain |
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| Hacettepe University | Not yet recruiting | Ankara | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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