Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: GlucoSEB Supplement (Capsule): GlucoSEB is a proprietary blend of enzymes, probiotics and herbal extract which together cause decline in sugar levels. Therefore, GlucoSEB would lower th
Sponsors
Advanced Enzymes Technologies Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Subjects will be included in the study if they meet all of the following criteria: 1. Age >=30 years, and of any gender. 2. Subjects with limited physical activity 3. BMI: 25 to 40 Kg/m2 4. Subjects who consume diet rich in carbohydrates ( >60%) 5. Subjects taking stable medicine dose for past 3 months 6. For prediabetic group, subjects with fasting blood sugar level (100-125 mg/dL) and HbA1c: 5.7 to 6.4% 7. For diabetic group, subjects with fasting blood sugar level (>= 130 mg/dL) and HbA1c: 7.0 to 9.5% 8. For diabetic group, subjects who are consuming biguanides (Metformin), sulfonylurea, SGLT-2 inhibitors, thiazolidinediones for blood glucose control. 9. Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
Exclusion criteria
Exclusion criteria: Subjects will be deemed ineligible to participate in the study if he/she fulfils any of the following criteria: 1. Pregnant and lactating female. 2. Subjects with BMI >= 40 3. Type I diabetic patients 4. For prediabetic group, subjects who are taking any sugar control supplements. 5. For diabetic group, subjects who are under the DPP-4 inhibitor, incretin mimetic, glucosidase inhibitor, rapid acting/short acting/ intermediate acting and premixed insulin-based treatment. 6. Subject with major chronic complications (including but not limited to) autoimmune disease, inflammation, etc. 7. Organic insufficiency (cardiac, hepatic, renal, respiratory) 8. Use of food supplements specifically containing fibers or polysaccharides 9. Chronic smoking and alcohol intake 10. Allergy to the ingredients in the test product. 11. History of any surgery in the past 3 months. 12. Subject currently taking or has in the past 30 days used GI related probiotics/prebiotics or any enzymes [prescription or over the counter (OTC)].
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postprandial glucose monitoring: Incremental increase in glucose concentration (iAUC) after standard meal consumption, comparison in response among placebo and test Timepoint: Postprandial glucose monitoring: Visit 3, 4, 5 and 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Maximum glucose concentration, Cmax: Determining maximum glucose concentration obtained after consumption of standard meal. 2. Time required to reach maximum glucose, Tmax: Determining time required to reach maximum glucose concentration after consumption of standard meal 3. Insulin secretion: Determining difference in insulin response after consuming standard meal among two arms, control & test. Timepoint: 1. Maximum glucose concentration, Cmax: Visit 3, 4, 5 & 6 2. Time required to reach maximum glucose, Tmax: Visit 3, 4, 5 & 6 3. Insulin secretion: Visit 3 & 5 at 0 hour, 2 hour & 4 hour | — |
Countries
India
Contacts
Public ContactDr Mukul Maurya
Sarvottam Hospital
Outcome results
None listed