The effect of canola oil compared with sesame and sesame-canola oil on cardio-metabolic biomarkers in patients with type 2 diabetes: Design and research protocol of a randomized, triple-blind, three-way, crossover clinical trial

Abstract

BACKGROUND Both canola and sesame oils consumption have been associated with favorable effects on cardio-metabolic biomarkers. However, to the best of our knowledge, no study has compared their effects on cardiovascular risk factors. The present study aimed to assess the effect of canola, sesame, and sesame-canola oils consumption on cardio-metabolic biomarkers in patients with type 2 diabetes mellitus (T2DM). METHODS This study was a randomized, triple-blind, three-way, crossover clinical trial. The study participants included 102 individuals with T2DM. Their spouses were also included in the study. The participants were entered into a 4-week run-in period. After that, their regular dietary oil was replaced with canola, sesame, or sesame-canola oils (a blend of sesame and canola oils) in three 9-week phases, which were separated by two 4-week washout periods (sunflower oil was consumed during the run-in and the washout periods). Dietary, physical activity, blood pressure, and anthropometric measurements were assessed at the beginning, in the middle (week 4-5), and at the end of each treatment phase. Blood samples were taken at the beginning and at the end of each phase. Serum, plasma, buffy coat, and whole blood samples were extracted and kept at -80 ºC for further analysis. Serum fasting blood sugar (FBS), triglyceride (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) were selected as the primary outcomes. RESULTS 102 participants with T2DM were randomly assigned to one of the 6 rolling methods. Through them, 93 individuals (91.2%) completely participated in all phases. CONCLUSION The present study will provide an exceptional opportunity to examine the effect of canola, sesame, and sesame-canola oil on cardio-metabolic markers in adults with and without T2DM. This trial will also provide a good medium for the investigation of gene-dietary oils interaction in the future.