title: Effect of Tocotrienols enriched canola oil on glycemic control and oxidative status in patients with type 2 diabetes mellitus: A randomized double-blind placebo-controlled clinical trial.
abstract: BACKGROUND
  Tocotrienols have been shown to improve glycemic control and redox balance in an animal study, but their effects on patients with diabetes are unknown. The study aimed to investigate whether tocotrienols improves glycemic control, insulin sensitivity, and oxidative stress in individuals with type 2 diabetes mellitus (T2DM).
  
  
  METHODS
  This study was a double-blinded, placebo-controlled, randomized trial. A total of 50 patients, aged 35-60 years, with T2DM treated by noninsulin hypoglycemic drugs were randomly assigned to receive either 15 mL/day tocotrienols (200 mg) enriched canola oil (n = 25) or pure canola oil (n = 25) for 8 weeks. Fasting blood sugar (FBS), fasting insulin, total antioxidant capacity (TAC), malondialdehyde (MDA), and homeostatic model assessment for insulin resistance (HOMA-IR) were determined before and after the intervention. The data were compared between and within groups, before and after the intervention.
  
  
  RESULTS
  Baseline characteristics of participants including age, sex, physical activity, disease duration, and type of drug consumption were not significantly different between the two groups. In tocotrienol enriched canola oil, FBS (mean percent change: -15.4% vs. 3.9%; P = 0.006) and MDA (median percent change: -35.6% vs. 16.3%; P = 0.003) were significantly reduced while TAC was significantly increased (median percent change: 21.4% vs. 2.3%; P = 0.001) compared to pure canola oil. At the end of the study, patients who treated with tocotrienols had lower FBS (P = 0.023) and MDA (P = 0.044) compared to the pure canola oil group. However, tocotrienols had no effect on insulin concentrations and HOMA-IR.
  
  
  CONCLUSIONS
  Tocotrienols can improve FBS concentrations and modifies redox balance in T2DM patients with poor glycemic control and can be considered in combination with hypoglycemic drugs to better control of T2DM.
authors.affiliation: Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran ; Endocrine Research Center, Firouzgar Hospital, Iran University of Medical Sciences, Tehran, Iran.
authors.forename: Mohammadreza
authors.initials: M
authors.lastname: Vafa
authors.affiliation: Department of Nutrition, School of Paramedicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
authors.forename: Neda
authors.initials: N
authors.lastname: Haghighat
authors.affiliation: Nutrition and Endocrine Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
authors.forename: Nazanin
authors.initials: N
authors.lastname: Moslehi
authors.affiliation: Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.
authors.forename: Shahriar
authors.initials: S
authors.lastname: Eghtesadi
authors.affiliation: Endocrine Research Center, Firouzgar Hospital, Iran University of Medical Sciences, Tehran, Iran ; Department of Endocrinology, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.
authors.forename: Iraj
authors.initials: I
authors.lastname: Heydari
keywords: Diabetes mellitus; hyperglycemia; oxidative stress; randomized controlled trial; tocotrienols