formulation of canola oil with γ-oryzanol and evaluation of the effectiveness of its consumption compared with unfortified canola and sunflower oils on certain cardiometabolic, oxidative stress and immunity indicators of adults with type 2 diabetes: a randomized controlled clinical trial study protocol

Background and objectives: diabetes mellitus is the most common endocrine disorder worldwide. cardiometabolic risk factors like truncal obesity and unhealthy life style including unhealthy diet contribute to development of type 2 diabetes (t2d) and its complications and attributable deaths. therefore, modification of the patient's diet and lifestyle is a core of t2d treatment. γ-oryzanol (orz) is a phytochemical found in rice bran oil. an increasing body of evidence has demonstrated health benefits of orz including decreasing oxidative stress and insulin resistance. this study will be conducted to examine possible effects of orz-fortified canola oil, as compared with plain canola and sunflower oils, on certain cardiometabolic indicators. materials and methods: a total of 90 adult subjects aged 20-65 y with confirmed diagnosis of t2d will randomly be allocated in one to the three groups to receive: (i) orz-fortified canola oil (14 mg orz/14g); (ii) plain canola oil (without orz); and (iii) sunflower oil. all oils will have equal amounts of vitamins d (4.5 μg =180 iu) and a (240 μg =800 iu) per serving, i.e. 14 g. the subjects will be instructed to use only the given oils for cooking during 12 weeks intervention period. dietary, anthropometric and laboratory evaluations will be done for all participants before and after the intervention. conclusions: the findings of this study will shed a light to our current knowledge of health aspects of cooking oils and also will input information to our future dietary recommendations to t2d patients and, probably, the general population.