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

Primary Purpose

Non Alcoholic Fatty Liver Disease, Lifestyle, Diet Modification

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Mediterranean Style
Sponsored by
Università degli Studi di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Alcoholic Fatty Liver Disease

Eligibility Criteria

20 Years - 59 Years (Adult)All SexesAccepts 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

Sites / Locations

  • ASST Spedali Civili Brescia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mediterranean Style

Arm Description

Educational intervention with personalized suggestions to improve diet and physical activity

Outcomes

Primary Outcome Measures

Weight loss
A reduction of at least 3 Kg
Body Mass Index (BMI) decrease
A dicresae of at least 1Kg/m2
Waist Circumference (WC) decrease
A decrease of at least 1.5 cm

Secondary Outcome Measures

Blood sugar level decrease
A decrease of 6 mg/dL
Blood cholesterol level decrease
A decrease of 9 mg/dL
Blood triglycerides level dicrease
A decrease of 12 mg/dL

Full Information

First Posted
September 28, 2017
Last Updated
May 22, 2019
Sponsor
Università degli Studi di Brescia
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1. Study Identification

Unique Protocol Identification Number
NCT03300661
Brief Title
Non Alcoholic Fatty Liver Disease: Nutritional Epidemiology and Lifestyle Medicine
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 13, 2017 (Actual)
Primary Completion Date
May 17, 2019 (Actual)
Study Completion Date
May 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi di Brescia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Alcoholic Fatty Liver Disease, Lifestyle, Diet Modification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A single cohort of patients with NAFLD, without control group.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mediterranean Style
Arm Type
Experimental
Arm Description
Educational intervention with personalized suggestions to improve diet and physical activity
Intervention Type
Behavioral
Intervention Name(s)
Mediterranean Style
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight loss
Description
A reduction of at least 3 Kg
Time Frame
12 months
Title
Body Mass Index (BMI) decrease
Description
A dicresae of at least 1Kg/m2
Time Frame
12 months
Title
Waist Circumference (WC) decrease
Description
A decrease of at least 1.5 cm
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Blood sugar level decrease
Description
A decrease of 6 mg/dL
Time Frame
12 months
Title
Blood cholesterol level decrease
Description
A decrease of 9 mg/dL
Time Frame
12 months
Title
Blood triglycerides level dicrease
Description
A decrease of 12 mg/dL
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiara Ricci, MD. PhD
Organizational Affiliation
Università degli Studi di Brescia
Official's Role
Principal Investigator
Facility Information:
Facility Name
ASST Spedali Civili Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Non Alcoholic Fatty Liver Disease: Nutritional Epidemiology and Lifestyle Medicine

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