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.