NAFLD: Independent Effects of Western Dietary Pattern Profile and Sedentary Life (ct-NAFLD)

Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

Status: Completed

Conditions: Fatty Liver

Treatments: Behavioral: diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02670590

AOVE

Details and patient eligibility

About

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..

Full description

Dietary and physical exercise counseling.

Enrollment: 150 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

NAFLD

Experimental group

Description:

diet

Treatment:

Behavioral: diet