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

NCT ID: NCT02670590

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2014-12-31

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.

Conditions

Fatty Liver

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NAFLD

diet

Group Type: EXPERIMENTAL

diet

Intervention Type: BEHAVIORAL

diet

Interventions

diet

diet

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

OTHER

Sponsor Role: lead

Responsible Party

Guglielmo Trovato, MD, PhD

Dirigente Medico

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

AOVE

Identifier Type: -

Identifier Source: org_study_id