The Effectiveness of a Mediterranean Diet Intervention in NAFLD Clinical Course
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Harokopio University
- Enrollment
- 44
- Primary Endpoint
- Regulation of hepatic steatosis
Study Overview
Brief Summary
The effects of Mediterranean Diet (MedDiet) on clinical, biochemical and inflammatory profile in NAFLD patients with simple steatosis. Potential associations of single nucleotide polymorphisms to diet composition and patients' profile were also investigated.
Detailed Description
Diet is a modifiable key factor targeted in prevention and management of non-alcoholic fatty liver disease (NAFLD). The aim of the study is to investigate the effect of Mediterranean Diet (MedDiet) on clinical, biochemical and inflammatory profile in NAFLD patients with simple steatosis. Potential associations of single nucleotide polymorphisms to diet composition and patients' profile are investigated. In this non-randomised, open-label study, 44 untreated NAFLD patients with non significant fibrosis receive nutritional counsel to increase adherence to MedDiet. Adherence to MedDiet is estimated with MedDietScore. Furthermore, genotyping of STAT3 rs2293152 and GCKR rs1260326 single nucleotide polymorphisms takes place.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •men and women >18y of age, no change in body weight (BW) for the last 6 months prior to the trial and body mass index (BMI) >25 kg/m2.
Exclusion Criteria
- •the presence of chronic viral hepatitis, the presence of congenital or acquired liver disease, the history of prior exposure to hepatotoxic drugs, the evidence of hepatic cirrhosis, ultrasonography values less than 1Hz, bariatric surgery, daily consumption of ethanol more than 20g for women and more than 30g for men for over 6 months during the last 5 years, any medication effective on fatty liver disease introduced <6 months prior to or during the trial, the co-presence of a life-threatening disease, psychiatric disorders impairing the patient's ability to provide written informed consent, age>65 years, pregnant or lactating women, subjects supplemented with omega-3 polyunsaturated fatty acids, probiotics/synbiotics, antioxidant vitamins and/or phytochemicals, any planned, structured and repetitive physical activity. Patients with any medication change during the trial were excluded from analysis.
Outcomes
Primary Outcomes
Regulation of hepatic steatosis
Time Frame: Change from Baseline to 6 months
A decrease in liver fat
Secondary Outcomes
- Adherence to MedDiet(Change from Baseline to 6 months)
- Association of single nucleotide polymorphisms to response to dietary treatment(Change from Baseline to 6 months)
- Regulation of visfatin(Change from Baseline to 6 months)
- Regulation of oxLDL(Change from Baseline to 6 months)
Investigators
Andriana C Kaliora
Assistant Professor, Human Nutrition and Foods
Harokopio University