Possible reduction of Blood Sugar and Cholesterol from using a blend of rice bran oil and sesame oil in comparison with soybean oil

INTERVENTION: Three groups of study participants (i.e. Diabetic, Non‐diabetic and Pre‐diabetic) were screened from the endocrine OPD of the hospital. The Diabetic group was randomized to receive either blend of rice bran oil and sesame oil (80: 20) or soybean oil as cooking oil medium for 12 weeks. Thus in this study group, the active intervention was the blended rice bran oil plus sesame oil (80: 20) and soybean oil was the control group. The oil packs were identical and coded. The codes were not available to anyone involved in the trial. Randomization schedule was generated using computer software. The randomization scheme was not made available to the hospital staff, study monitors and other designated individuals at the study site. The codes were broken after the last follow‐up visit i.e. after study completion. Non‐diabetic and pre‐diabetic subjects were given blend of rice bran oil and sesame oil (80: 20) only. All participants had 3 follow‐up visits at 4 week intervals. Laboratory investigations were done at each follow‐up visit. CONDITION: 1. Type‐2 Diabetes 2. Pre Diabetic 3. Non‐diabetic ; Nutritional, Metabolic, Endocrine PRIMARY OUTCOME: ; 1. Fasting Blood Glucose (FBG) measured at baseline, 4 weeks, 8 weeks, and 12 weeks; 2. Postprandial Blood Glucose (PPBG) measured at baseline, 4 weeks, 8 weeks, and 12 weeks; 3. Haemoglobin A1C (HbA1C) measured at baseline and 12 weeks; SECONDARY OUTCOME: ; 1. Body weight measured at baseline, 4 weeks, 8 weeks, and 12 weeks; 2. Height measured at baseline, 4 weeks, 8 weeks, and 12 weeks; 3. Systolic Blood Pressure (SBP) measured at baseline, 4 weeks, 8 weeks, and 12 weeks; 4. Diastolic Blood Pressure (DBP) measured at baseline, 4 weeks, 8 weeks, and 12 weeks; 5. Total Cholesterol (TC) measured at baseline and 12 weeks; 6. Low density Lipoproteins (LDL) measured at baseline and 12 weeks; 7. Very Low density Lipoproteins (VLDL) measured at baseline and 12 weeks; 8. High Density Lipoproteins (HDL) measured at baseline and 12 weeks; 9. Serum Triglycerides (TG) measured at baseline and 12 weeks; 10. Aspartate Aminotransferase (AST) measured at baseline and 12 weeks; 11. Alanine aminotransferase (ALT) measured at baseline and 12 weeks; 12. Alkaline Phosphatase (ALP) measured at baseline and 12 weeks; 13. Seum Bilirubin measured at baseline and 12 weeks; 14. Serum Urea measured at baseline and 12 weeks; 15. Serum Creatinine measured at baseline and 12 weeks; 16. Serum Uric acid measured at baseline and 12 weeks; INCLUSION CRITERIA: 1. Patients with Diabetes 1.1 Men and women age 25 to 65 years 1.2 Fasting blood glucose more than 125 mg/dL or HbA1c more than 6.5 1.3 On stable oral anti‐diabetic therapy for past 4 weeks or more 1.4 Willing to give informed consent 1.5 Number of adult family members less than 5 2. Subjects with pre‐diabetes 2.1 Men and women age 25 to 65 years 2.2 Fasting blood glucose more than 100 and less than 125 mg/dL or HbA1c between 5.7 ‐ 6.5 2.3 Willing to give informed consent 2.4 Number of adult family members less than 5 3. Healthy Volunteers 3.1 Men and women age 25 to 65 years 3.2 Fasting Blood Glucose less than 100 mg/dL or HbA1C <5.7 3.3 Willing to give informed consent