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

Not Applicable

Completed

• Conditions: Fatty Liver
• Interventions: Behavioral: diet

• Registration Number: NCT02670590
• Lead Sponsor: 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..

Detailed Description

Dietary and physical exercise counseling.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Study First Submitted: 2016-01-15
• Study First Submitted QC: 2016-02-01
• Study First Posted: 2016-02-02
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-09
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NAFLD	diet	diet

Primary Outcome Measures

Name	Time	Method
Decrease of fatty liver appearance by ultrasound	6 months