Non Alcoholic Fatty Liver Disease: Nutritional Epidemiology and Lifestyle Medicine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-13

Study Completion Date

2019-05-20

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.

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Detailed Description

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Conditions

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Non Alcoholic Fatty Liver Disease Lifestyle Diet Modification

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A single cohort of patients with NAFLD, without control group.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mediterranean Style

Educational intervention with personalized suggestions to improve diet and physical activity

Group Type EXPERIMENTAL

Mediterranean Style

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes