The effects of curcumin supplementation on fasting triglyceride levels in patients with hypertriglyceridemia taking statin: A randomized double-blind clinical trial

The aim of this study is to investigate the effects of curcumin on serum triglyceride levels in patients with hypertriglyceridemia taking statins. Subjects with a history of hyperlipidemia taking a statin and have a fasting triglyceride level of > 150 mg/dL will be recruited in this study. The study groups will be assigned to receive 500 mg/day curcumin (n= 50) or placebo (n= 50) for a period of 8 weeks. Blinding will be used for the patients, researchers and the statistician. Curcumin and placebo capsules will be encoded by another person, who is not a member of the research team. These codes will be remained confidential until statistical analysis of the results is done. The shape, weight and color of placebo capsules are as same as the original drug (curcumin). Patients are randomized based on the tables of random numbers of the Fleiss book into drug and placebo groups. Then, these random codes will be assigned to patients in sealed envelopes to observe allocation concealment. A history of renal diseases, malabsorption syndrome, biliary obstruction, cancers, or inflammatory or systemic diseases, taking non-statin lipid-lowering drugs, pregnancy or breast-feeding, fasting triglycerides > 400 mg/dl are exclusion criteria. The blood samples will be taken after 12 hours of fasting at baseline and after the intervention period. Serum levels of lipid profile (including total cholesterol, LDL-C, HDL-C and triglycerides), lipoprotein (a), the glycemic indices (including FBG, insulin and HbA1c), adiponectin, leptin and CRP will be measured in all samples and compared between the two study groups.

Vice chancellor for research, Mashhad University of Medical Sciences