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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.
 
ClinicalTrials.gov Identifier: NCT02670590
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Guglielmo Trovato, MD, PhD, Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

Tracking Information
First Submitted Date  ICMJE January 15, 2016
First Posted Date  ICMJE February 2, 2016
Last Update Posted Date July 11, 2017
Study Start Date  ICMJE January 2011
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2016)
Decrease of fatty liver appearance by ultrasound [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NAFLD: Independent Effects of Western Dietary Pattern Profile and Sedentary Life
Official Title  ICMJE NAFLD: Independent Effects of Western Dietary Pattern Profile and Sedentary Life
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fatty Liver
Intervention  ICMJE Behavioral: diet
diet
Study Arms  ICMJE Experimental: NAFLD
diet
Intervention: Behavioral: diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2016)
150
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02670590
Other Study ID Numbers  ICMJE AOVE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Guglielmo Trovato, MD, PhD, Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
Study Sponsor  ICMJE Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP