Effectiveness of Co-Administration of Camelina Oil and Caloric Restriction on Cardiometabolic Risk Factors, Liver Function and Mental Health in Patients with Non-Alcoholic Fatty Liver Disease: A Blinded Randomized Controlled Trial Protocol

Background: Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease (CLD). Omega-3 fatty acids and antioxidants co-supplementation have been considered as an alternative treatment in NAFLD. This trial will evaluate camelina sativa oil (CSO) effects as a rich source of omega-3 fatty acids and antioxidants on cardiometabolic risk factors, metabolic endotoxemia, liver enzymes, hepatic steatosis, and mental health in NAFLD patients. Methods: Forty-six patients with NAFLD will be randomly assigned to either a CSO supplementation or placebo for 12 weeks. Both groups will receive a weight-loss diet too. Insulin resistance, oxidative stress, anti/inflammatory biomarkers, lipid profile, adiponectin, lipopolysaccharide (LPS), anthropometric indices, liver enzymes, hepatic steatosis, and cortisol will be assessed all patients at baseline and post-intervention. DASS and GHQ questionnaires will be completed for all patients at baseline and post-intervention. Results: The CSO is expected to reduce hepatic steatosis and improve cardiometabolic risk factors, liver function, and mental health compared to the placebo group after 12 weeks. Conclusion: The CSO as a phytopharmaceutical drug may improve cardiometabolic risk factors, metabolic endotoxemia, liver enzymes, hepatic steatosis, and mental health in patients with NAFLD.