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Effect of fish oil supplementation on the concentration of miRNA-122, FGF-21 and liver fibrosis in patients with NAFLD: Stu ... 1 1. Introduction 2 1.1. Study objectives 2 2. Materials and methods 2 2.1. Design 2 2.2. Eligibility criteria 2 2.3. Recruitment 2 2.4. Randomization and blinding 2 2.5. Intervention 3 2.6. Outcomes 4 2.6.1. Primary outcome 4 2.6.2. Secondary outcome 4 2.6.3. Exploratory variables 4 2.7. Data collection and management 5 2.7.1. Blood collection 5 2.7.2. Quantification of miRNA expression 5 2.7.3. Quantification of FGF-21 concentration 5 2.7.4. Determination of fatty acid profile in erythrocytes 5 2.7.5. Assessment of laboratory markers 5 2.7.6. Assessment of hepatic steatosis and fibrosis 5 2.7.7. Anthropometry and body composition 6 2.7.8. Physical activity level 6 2.7.9. Resting energy expenditure 6 2.7.10. Dietary assessment 6 2.7.11. Feasibility and safety 6 2.8. Data management 6 2.9. Data quality 7 2.10. Sample size 7 2.11. Statistical methods 7 3. Discussion 7 Progress of the research 7 Authors contribution 7 Financing 7 Availability of data and materials 8 Ethical aspects 8 Declaration of conflict of interest 8 Acknowledgment 8 Appendix A. Suppleme

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UND

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nonfiction