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The study is an open-label intervention non pharmacological Cohort Study without control arm in patients with Non Alcoholic Fatty Liver Disease (NAFLD) and in healthy subjects.
The intervention in patients with NAFLD is educational, providing personalized suggestions to improve diet and physical activity; the intervention in healthy subjects is educational, providing general suggestions to improve diet and physical activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean Style | Experimental | Educational intervention with personalized suggestions to improve diet and physical activity |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean Style | Behavioral | After completion of a Food Frequency Questinnaire (FFQ) and the International Physical Activity Questionnaire (IPAQ), patients enrolled in the study undergo a personalized educational intervention by a registered dietician. During the intervention the dietician advice about the main errors in diet and physical activity (by FFQ and IPAQ) and chooses three aims in diet modification and one aim in physical activity improvement. Patients adherence is assessed by the same dietician every three months, using FFQ and IPAQ, and futher supports are provided. Total intervention lenght is twelve months. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | A reduction of at least 3 Kg | 12 months |
| Body Mass Index (BMI) decrease | A dicresae of at least 1Kg/m2 | 12 months |
| Waist Circumference (WC) decrease | A decrease of at least 1.5 cm | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood sugar level decrease | A decrease of 6 mg/dL | 12 months |
| Blood cholesterol level decrease | A decrease of 9 mg/dL | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chiara Ricci, MD. PhD | Università degli Studi di Brescia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASST Spedali Civili Brescia | Brescia | 25123 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38303926 | Derived | Zanini B, Benini F, Marullo M, Simonetto A, Rossi A, Cavagnoli P, Bonalumi A, Marconi S, Pigozzi MG, Gilioli G, Valerio A, Donato F, Castellano M, Ricci C. Mediterranean-Oriented Dietary Intervention Is Effective to Reduce Liver Steatosis in Patients with Nonalcoholic Fatty Liver Disease: Results from an Italian Clinical Trial. Int J Clin Pract. 2024 Jan 25;2024:8861126. doi: 10.1155/2024/8861126. eCollection 2024. |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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A single cohort of patients with NAFLD, without control group.
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| Blood triglycerides level dicrease | A decrease of 12 mg/dL | 12 months |