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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615001010583
Acronym
MEDINA
Enrollment
94
Registered
2015-09-28
Start date
2015-04-14
Completion date
2017-04-11
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to determine if the Mediterranean Diet (MD) compared to standard care (low fat diet), can reduce the severity of NAFLD and other symptoms often associated with NAFLD namely the Metabolic Syndrome (MetS). The components of the MetS which this study aims to monitor and potentially reduce includes: high blood pressure, increased waist circumference, elevated triglycerides (bad fats in the blood), reduced HDL cholesterol (good fats in the blood) and elevated glucose levels. These symptoms are referred to as the Metabolic Syndrome (MS).

Interventions

Mediterranean Dietary Intervention versus standard diet. This involves randomizing patients to either a Mediterranean Diet intervention arm versus a standard diet (low fat, moderate Carbohydrate) intervention. An Accredited Practicing Dietitian (APD) will provide a dietary consult for intervention patients to follow a Med Diet protocol or patients following a standard protocol (low fat, Australian Guide to Healthy Eating). A food hamper representing typical Mediterranean Diet foods (for example

Mediterranean Dietary Intervention versus standard diet. This involves randomizing patients to either a Mediterranean Diet intervention arm versus a standard diet (low fat, moderate Carbohydrate) intervention. An Accredited Practicing Dietitian (APD) will provide a dietary consult for intervention patients to follow a Med Diet protocol or patients following a standard protocol (low fat, Australian Guide to Healthy Eating). A food hamper representing typical Mediterranean Diet foods (for example olive oil, nuts, natural Greek yoghurt, legumes) will be provided to the intervention group and a supermarket voucher will be provided for the standard group to purchase low fat, moderate carbohydrate food products to achieve the dietary goals. These will be provided at baseline, 6 weeks and 12 weeks. Meal plans and recipe books are all provided at baseline to the relevant diet group. The intervention will be run over a 12 week period with a further 6 and 12month follow up to assess duration of effect and feasibility of sustaining the diet. The dietary intervention and standard diet consults will be delivered by an APD through a face-to-face consultation initially and face-to-face consultations at mid-intervention (6 weeks) and post-intervention timepoints. There are regular phone call reviews to check dietary compliance at weeks 2, 4 and 9. A dietitian will administer the intervention and to monitor adherence food diaries, food frequency questionnaire, plasma fatty acids and urinary hydroxytyrosol will be used as measures for compliance.

Sponsors

La Trobe University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 14, 2026