NCT02670590

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fatty Liver

Interventions

Type	Name	Description
BEHAVIORAL	diet	diet

Timeline

• Start date: 2011-01-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2016-02-02
• Last updated: 2017-07-11