Non Alcoholic Fatty Liver Disease: Nutritional Epidemiology and Lifestyle Medicine
Not Applicable
Completed
- Conditions
- Non Alcoholic Fatty Liver DiseaseLifestyleDiet Modification
- Interventions
- Behavioral: Mediterranean Style
- Registration Number
- NCT03300661
- Lead Sponsor
- Università degli Studi di Brescia
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mediterranean Style Mediterranean Style Educational intervention with personalized suggestions to improve diet and physical activity
- Primary Outcome Measures
Name Time Method Body Mass Index (BMI) decrease 12 months A dicresae of at least 1Kg/m2
Waist Circumference (WC) decrease 12 months A decrease of at least 1.5 cm
Weight loss 12 months A reduction of at least 3 Kg
- Secondary Outcome Measures
Name Time Method Blood cholesterol level decrease 12 months A decrease of 9 mg/dL
Blood triglycerides level dicrease 12 months A decrease of 12 mg/dL
Blood sugar level decrease 12 months A decrease of 6 mg/dL
Trial Locations
- Locations (1)
ASST Spedali Civili Brescia
🇮🇹Brescia, Italy