Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications
Conditions
Interventions
Intervention1: SucroSEB: 500mg, 2 capsules per meal (lunch and dinner), oral route of administration - swallow as a whole with water just before having meal, for 180 days
Intervention2: SEB TG: 500mg
Sponsors
Advanced Enzymes Technologies Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with less physical activity. 2. BMI 18.5 to 35 Kg/m2. 3. Subjects with recent HbA1c reports within 2 weeks can be considered as screening value for participation in the study. 4. Subjects taking stable medicine dose for past 3 months. 5. Subjects who occasionally consume sweets/beverages containing sugar. 6. Subjects with fasting blood sugar level greater than or equal to 130 mg/dL and HbA1c 7.0 to 11.0%. 7. Subjects must have a history of diabetes for more than 1 year and have been on a stable medication. regimen for at least the past 9 months. 8. Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating female 2. Subjects with BMI greater than or equal to 35 3. Type I diabetic patients 4. HbA1c less than 7.0 and greater than 11.0% 5. Diabetes medication (DPP4 inhibitors, Acarbose, Voglibose, Repaglinide, GLP-1 receptor agonists (GLP1RA), and Insulin) 6. Patients 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 |
|---|---|
| Change in Gut microbiome from baseline to end of treatment (assessment on Day 1 and Day 180)Timepoint: 180 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in HbA1c (assessment on Day -1 to Day -7, Day 90 & Day 180) 2. Change in fasting blood glucose (assessment on Day -1 to Day -7, Day 90 & Day 180) 3. Change in fasting insulin (assessment on Day 1, Day 90 & Day 180) 4. Change in Lipid profile (assessment on Day 1, Day 90 & Day 180) - Quantification of TC, TG, LDL, HDL, VLDL 5. Change in anthropometric parameters (assessment on day -1 to -7, Day 1, Day 90 & Day 180) - Body mass index (BMI), Waist circumference (WC), Waist-to-hip ratio (WHR) 6. Assess the peak plasma levels of Glucagon Like peptide-1 (GLP-1) at day 1, & day 180. 7. Questionnaire based assessment - Hunger & satiety scale, 36-Item Short Form Survey Instrument (SF-36), VAS Scale for bowel movement on Day 1, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90, Day 105, Day 120, Day 135, Day 150, Day 165 & Day 180Timepoint: 180 days;8. Liver & Renal safety analysis (assessment on Day 1, Day 90 & Day 180)- Check levels of AST, ALT, hsCRP, BUN, total albumin & globulin. 9. CBC analysis & vital sign check (assessment on Day 1, Day 90 & Day 180) 10. Monitoring subjects for any side effects occurred during the treatment. (weekly follow up- telephonic or paper record), in accordance with complemented by a Tolerability Scale or Assessment to provide a structured evaluation of the products safety. 11. Tolerability - The tolerance of the product by participants assessments for any side effect such as Nausea, Vomiting, Bloating, Abdominal cramps & heartburn experienced during the study. The tolerability will be evaluated by the intensity of each individual symptom on a validated 5-point Likert scale (0-no problem, 1-mild problem, 2-moderate problem, 3-severe problem & 4-very severe problem)Timepoint: 180 days;12. Rate of incidence of AE & SAEs - Recording any adverse (AE) or serious adverse event (SAE) from Day 1 to Day 180.Timepoint: 180 days | — |
Countries
India
Contacts
Public ContactDr Mukul Maurya
Advanced Enzymes Technologies Ltd
Outcome results
None listed