Non Alcoholic Fatty Liver Disease: Nutritional Epidemiology and Lifestyle Medicine

Study Overview
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Brief Summary
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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.

Official Title
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Open-label, Non-Pharmacological, Intervention Cohort Study Without Control Arm, in Patients With Non Alcoholic Fatty Liver Disease and in Healthy Subjects.

Conditions
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Non Alcoholic Fatty Liver Disease, Lifestyle, Diet Modification

Intervention / Treatment
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* Behavioral: Mediterranean Style


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of Fatty Liver at ultrasonography Exclusion Criteria: Pregnancy; Breast Feeding Cirrhosis or End Stage Liver Disease Fatty Liver due to Hepatic Diseases other than Non Alcoholic Fatty Liver disease Concomitant severe clinical condition

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A single cohort of patients with NAFLD, without control group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mediterranean Style<br>Educational intervention with personalized suggestions to improve diet and physical activity | Behavioral: Mediterranean Style<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Blood triglycerides level dicrease | A decrease of 12 mg/dL | 12 months |