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

May 22, 2019 updated by: Chiara Ricci, Università degli Studi di Brescia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, 25123
        • ASST Spedali Civili Brescia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mediterranean Style
Educational intervention with personalized suggestions to improve diet and physical activity
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: 12 months
A reduction of at least 3 Kg
12 months
Body Mass Index (BMI) decrease
Time Frame: 12 months
A dicresae of at least 1Kg/m2
12 months
Waist Circumference (WC) decrease
Time Frame: 12 months
A decrease of at least 1.5 cm
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood sugar level decrease
Time Frame: 12 months
A decrease of 6 mg/dL
12 months
Blood cholesterol level decrease
Time Frame: 12 months
A decrease of 9 mg/dL
12 months
Blood triglycerides level dicrease
Time Frame: 12 months
A decrease of 12 mg/dL
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Brescia

Investigators

  • Principal Investigator: Chiara Ricci, MD. PhD, Università degli Studi di Brescia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2017

Primary Completion (Actual)

May 17, 2019

Study Completion (Actual)

May 20, 2019

Study Registration Dates

First Submitted

September 28, 2017

First Submitted That Met QC Criteria

September 28, 2017

First Posted (Actual)

October 3, 2017

Study Record Updates

Last Update Posted (Actual)

May 23, 2019

Last Update Submitted That Met QC Criteria

May 22, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ubrescia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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