Fatty Liver Clinical Trial
— ct-NAFLDOfficial title:
NAFLD: Independent Effects of Western Dietary Pattern Profile and Sedentary Life
Verified date | July 2017 |
Source | Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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..
Status | Completed |
Enrollment | 150 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decrease of fatty liver appearance by ultrasound | 6 months |
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