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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02670590
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : July 11, 2017
Information provided by (Responsible Party):
Guglielmo Trovato, MD, PhD, Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

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..

Condition or disease Intervention/treatment Phase
Fatty Liver Behavioral: diet Not Applicable

Detailed Description:
Dietary and physical exercise counseling.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NAFLD: Independent Effects of Western Dietary Pattern Profile and Sedentary Life
Study Start Date : January 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: NAFLD
Behavioral: diet

Primary Outcome Measures :
  1. Decrease of fatty liver appearance by ultrasound [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Responsible Party: Guglielmo Trovato, MD, PhD, Dirigente Medico, Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele Identifier: NCT02670590    
Other Study ID Numbers: AOVE
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Fatty Liver
Liver Diseases
Digestive System Diseases