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

Sponsor
Università degli Studi di Brescia (Other)
Overall Status
Completed
CT.gov ID
NCT03300661
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
23.2
Actual Duration (Months)
4.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mediterranean Style
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
A single cohort of patients with NAFLD, without control group.A single cohort of patients with NAFLD, without control group.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open-label, Non-Pharmacological, Intervention Cohort Study Without Control Arm, in Patients With Non Alcoholic Fatty Liver Disease and in Healthy Subjects.
Actual Study Start Date :
Jun 13, 2017
Actual Primary Completion Date :
May 17, 2019
Actual Study Completion Date :
May 20, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Weight loss [12 months]

    A reduction of at least 3 Kg

  2. Body Mass Index (BMI) decrease [12 months]

    A dicresae of at least 1Kg/m2

  3. Waist Circumference (WC) decrease [12 months]

    A decrease of at least 1.5 cm

Secondary Outcome Measures

  1. Blood sugar level decrease [12 months]

    A decrease of 6 mg/dL

  2. Blood cholesterol level decrease [12 months]

    A decrease of 9 mg/dL

  3. Blood triglycerides level dicrease [12 months]

    A decrease of 12 mg/dL

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 59 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ASST Spedali Civili Brescia Brescia Italy 25123

Sponsors and Collaborators

  • Università degli Studi di Brescia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chiara Ricci, Associate Professor, Università degli Studi di Brescia
ClinicalTrials.gov Identifier:
NCT03300661
Other Study ID Numbers:
  • Ubrescia
First Posted:
Oct 3, 2017
Last Update Posted:
May 23, 2019
Last Verified:
May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of May 23, 2019