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

Vali  Musazadeh; Parvin  Dehghan; Sodeif  Azadmard-Damirchi

doi:10.18502/jnfs.v7i3.10204

Vali Musazadeh Student research committee, School of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.
Parvin Dehghan Nutrition Research Center, School of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.
Sodeif Azadmard-Damirchi Department of Food Science and Technology, School of Agriculture, University of Tabriz, Tabriz, Iran.

DOI: https://doi.org/10.18502/jnfs.v7i3.10204

Keywords: Fatty acids omega-3; Camelina oil; Oxidative stress; Inflammatory biomarkers; Non-alcoholic fatty liver disease

Abstract

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.