MEDINA: Mediterranean Dietary Intervention Study in Nonalcoholic Fatty Liver Disease (NAFLD) patients

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes; on Alcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis; Cardiovascular Disease; Non Alcoholic Fatty Liver Disease; Diet and Nutrition - Other diet and nutrition disorders; Metabolic and Endocrine - Other metabolic disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12615001010583
• Lead Sponsor: a Trobe University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified