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
About this trial
This is an interventional treatment trial for Fatty Liver
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
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
NCT ID
NCT02670590
First Posted
January 15, 2016
Last Updated
July 9, 2017
Sponsor
Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
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
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