Dietary intervention with octacosanol & vitamin K2 supplement on lipid profile, oxidative stress and inflammation in patients on atorvastatin therapy

This study was focused on the influence of octacosanol supplementation on proprotein convertase subtilisin kexin type 9 (PCSK9) level and lipid profile in patients on chronic atorvastatin therapy. The subjects were randomly assigned to receive either dietary supplement which consists of octacosanol (20 mg) and vitamin K2 (45 µg) (AbelaPharm, Belgrade, Serbia) or placebo. Participants used 1 capsule, either dietary supplement (octacosanol + vitamin K2) or placebo, daily with an evening meal. The subjects visited the research center three times during the study: at baseline, after 8 and 13 weeks. The diet was monitored by 3-day food record kept at baseline and at the end of the study. At each study visit, the participants underwent physician and clinical examination, as well as all anthropometric measurements. A questionnaire assessing smoking status, alcohol consumption and intake of medications was also filled out. Physical and clinical examination, vital signs, laboratory parameters (alanine aminotransferase (ALT), serum aspartate aminotransferase (AST), creatine phosphokinase (CK) and fasting glucose) were evaluated for safety assessment. Participants had to bring all used empty and unused study supplements. At each visit any unusual or adverse effect was reported in the appropriate record forms.