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

NCT02670590 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-07-11

No results posted yet for this study

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..

Conditions

Interventions

BEHAVIORAL

diet

diet

Sponsors & Collaborators

  • Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-12-31
Completion
2014-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02670590 on ClinicalTrials.gov