Non Alcoholic Fatty Liver Disease: Nutritional Epidemiology and Lifestyle Medicine (SEELN)

Università degli Studi di Brescia

Status: Completed

Conditions: Lifestyle; Non Alcoholic Fatty Liver Disease; Diet Modification

Treatments: Behavioral: Mediterranean Style

Study type: Interventional

Funder types: Other

Identifiers

NCT03300661

Ubrescia

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 20 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Mediterranean Style

Experimental group

Description:

Educational intervention with personalized suggestions to improve diet and physical activity

Treatment:

Behavioral: Mediterranean Style