1. Type-2 Diabetes 2. Pre Diabetic 3. Non-diabetic Nutritional, Metabolic, Endocrine
Conditions
Interventions
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 ric
Sponsors
Pharmainstinct
Eligibility
Sex/Gender
All
Inclusion criteria
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 3.4 Number of adult family members less than 5
Exclusion criteria
Exclusion criteria: 1. BMI more than or equal to 30 kg/m2 2. Patients consuming laxatives for more than twice a month 3. Consuming more than or equal to 20g alcohol per day and/or more than 10 cigarettes per day 4. Lactating or pregnant mothers 5. Regular users of rice bran oil, or sesame oil for the last 3 months 6. Those who take more than 2 major meals per week outside home or frequent travellers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Outcome results
None listed