search
Back to results

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

Primary Purpose

Fatty Liver

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
diet
Sponsored by
Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatty Liver

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    NAFLD

    Arm Description

    diet

    Outcomes

    Primary Outcome Measures

    Decrease of fatty liver appearance by ultrasound

    Secondary Outcome Measures

    Full Information

    First Posted
    January 15, 2016
    Last Updated
    July 9, 2017
    Sponsor
    Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02670590
    Brief Title
    NAFLD: Independent Effects of Western Dietary Pattern Profile and Sedentary Life
    Acronym
    ct-NAFLD
    Official Title
    NAFLD: Independent Effects of Western Dietary Pattern Profile and Sedentary Life
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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..
    Detailed Description
    Dietary and physical exercise counseling.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fatty Liver

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    NAFLD
    Arm Type
    Experimental
    Arm Description
    diet
    Intervention Type
    Behavioral
    Intervention Name(s)
    diet
    Intervention Description
    diet
    Primary Outcome Measure Information:
    Title
    Decrease of fatty liver appearance by ultrasound
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    NAFLD: Independent Effects of Western Dietary Pattern Profile and Sedentary Life

    We'll reach out to this number within 24 hrs