The effects of a Mediterranean Dietary Intervention on insulin resistance and hepatic steatosis in patients with Nonalcoholic Fatty Liver Disease (NAFLD).

a Trobe University0 sites94 target enrollmentSeptember 28, 2015

Overview

No summary available.

Registry

who.int

Start Date

September 28, 2015

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

a Trobe University

•Participants will be included if they are \>18years, BMI 20\-40kg/m2, Patients must have had at least one elevated serum aminotransferase (ALT) level (\>20U/L female,
•\>30 U/L male) during the past 6 months and at screening have a level between \>1\.5 and \<5 times Upper Limit of Normal (ULN) in the absence of another cause of liver disease. Diagnosis of NAFLD upon u/s.

•Participants will be excluded if: they are non\-English speaking; refusal or inability to give informed consent; average weekly alcohol ingestion \>140g males or females; a current or past history of cardiovascular, cerebrovascular or peripheral vascular disease; presence of clinically relevant pulmonary, gastro\-intestinal, renal, haematological, neurological, psychiatric, systemic or any acute infectious disease or signs of acute illness; Women who are pregnant or currently breastfeeding; Psychosocial or gastrointestinal (malabsorptive conditions e.g. coeliac disease) contraindications included bulimia nervosa, substance abuse, clinically significant depression, or current psychiatric care. Recent (within 3months of screening visit) change in dose/regimen or introduction of Vitamin E, Vitamin C or high dose Vitamin D, fish oil or probiotics. Participation in any other clinical study targeting diet and lifestyle factors.