Non Alcoholic Fatty Liver Disease: Nutritional Epidemiology and Lifestyle Medicine

Diet Modification Clinical Trial

— SEELN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03300661
• Other study ID #: Ubrescia
• Status: Completed
• Phase: N/A
• Start date: June 13, 2017
• Est. completion date: May 20, 2019

Study information

• Verified date: May 2019
• Source: Università degli Studi di Brescia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 20, 2019
• Est. primary completion date: May 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet Modification
• Fatty Liver
• Lifestyle
• Liver Diseases
• Non Alcoholic Fatty Liver Disease
• Non-alcoholic Fatty Liver Disease

Intervention

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.

Locations

Country	Name	City	State
Italy	ASST Spedali Civili Brescia	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Brescia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	A reduction of at least 3 Kg	12 months
Primary	Body Mass Index (BMI) decrease	A dicresae of at least 1Kg/m2	12 months
Primary	Waist Circumference (WC) decrease	A decrease of at least 1.5 cm	12 months
Secondary	Blood sugar level decrease	A decrease of 6 mg/dL	12 months
Secondary	Blood cholesterol level decrease	A decrease of 9 mg/dL	12 months
Secondary	Blood triglycerides level dicrease	A decrease of 12 mg/dL	12 months