Efficacy of Delta-Tocotrienol vs Placebo on control of blood glucose level in prediabetic patients – A randomized controlled trial

INTERVENTION: Study setting: This study will be conducted at Maga Medical Complex/Armed Forces Institutes of Pathology (AFIP), National University of Medical Sciences Rawalpindi, Pakistan. Randomization: The prediabetic patients will be assigned to one of the two arms consisting of (A) intervention nutritional supplements (NS) and (B) control placebo (PS) arm by simple randomization. Details of intervention: Patients in the NS arm will be assigned to receive nutritional supplement capsule (Delta‐tocotrienol 300 mg) once daily orally for 12 weeks. Patients in PS arm will receive a matching placebo (cellulose 300 mg) for the same frequency and duration. During the study period, participants in both arms will be requested to avoid consuming vitamin E, resveratrol or anti‐ inflammatory drugs. Masking will be carried out as follows: Participants: Blinded Healthcare providers: Blinded CONDITION: Prediabetes PRIMARY OUTCOME: 1.Improvement of glycemic control including mean reduction in measurement of fasting plasma glucose (mmol/L) and HbA1c (mmol/L) at 12 weeks with baseline values [At the baseline of the study and at 12 weeks after Delta‐Tocotrienol supplementation (NS).]; SECONDARY OUTCOME: Mean reduction in insulin resistance by measuring fasting blood glucose, (mmol/L), serum insulin (IU/L) and Homeostatic Model Assessment of Insulin Resistance (HOMA IR). ; [At the baseline of the study and at 12 weeks after Delta‐Tocotrienol supplementation (NS).]; INCLUSION CRITERIA: * Both men and women * Aged 18‐60 years * Participants who are diagnosed to have Prediabetic criteria: a. Impaired fasting plasma glucose level (5.6‐6.9mmol/L) or/and b. Glycosylated hemoglobin (HbA1c) 5.7% to 6.4%