NCT03300661

Non Alcoholic Fatty Liver Disease: Nutritional Epidemiology and Lifestyle Medicine

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Università degli Studi di Brescia · Academic / Other
• Sex: All
• Age: 20 Years – 59 Years
• Healthy volunteers: Accepted

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.

Conditions

• Non Alcoholic Fatty Liver Disease
• Lifestyle
• Diet Modification

Interventions

Type	Name	Description
BEHAVIORAL	Mediterranean Style	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.

Timeline

• Start date: 2017-06-13
• Primary completion: 2019-05-17
• Completion: 2019-05-20
• First posted: 2017-10-03
• Last updated: 2019-05-23

Locations

1 site across 1 country: Italy