NAFLD: Independent Effects of Western Dietary Pattern Profile and Sedentary Life (ct-NAFLD)

July 9, 2017 updated by: Guglielmo Trovato, MD, PhD, Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
Investigators perform a counseling intervention study (6 months) in adult subjects with evidence of Fatty Liver by Ultrasound, graded 0-3 according to the Bright Liver Score (BLS); exclusion criteria are diabetes, renal insufficiency (glomerular filtration rate < 90 ml/min), cancer, heart failure > II NYHA ( New York Heart Association) Class), chronic virus hepatitis, and cirrhosis. Insulin resistance was assessed as homeostasis model assessment-insulin resistance (HOMA-IR) . Suggestions and advice on individual "healthy" food purchase, storage, and cooking were given. Reliable feedback and evidence of patients' adherence were obtained by scheduled dietician's interviews. Investigators will challenge the predictive effects of the Adherence to Mediterranean Diet, of Western dietary profile score and of increased physical activity at 6 months in a body mass index changes-balanced model to detect independent effects, if any, of the studied variable on NAFLD persistence, amelioration or disappearance. Threshold and odds of Mediterranean and Western dietary profile score will be calculated by contingency tables and receiver operator characteristic curve (ROC) analysis..

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dietary and physical exercise counseling.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

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

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinical diagnosis of fatty liver

Exclusion Criteria:

  • type I or type II diabetes,
  • no alcohol, cancer, malnutrition, severe obesity, renal insufficiency, viral hepatitis, other chronic disease

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: NAFLD
diet
Behavioral: diet
diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decrease of fatty liver appearance by ultrasound
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

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

January 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 15, 2016

First Submitted That Met QC Criteria

February 1, 2016

First Posted (Estimate)

February 2, 2016

Study Record Updates

Last Update Posted (Actual)

July 11, 2017

Last Update Submitted That Met QC Criteria

July 9, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOVE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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