Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: DiabeSmart atta additive: Food prepared using DiabeSmart atta additive will be provided once on Day 2
Intervention2: 1. DiabeSmart atta additive
2. DiabeSmart South Indian Mixture
3.
Sponsors
Bajo Foods Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged 30-55 years both inclusive. 2. Subjects with history of prediabetes (5.7-6.4%) and Diabetes mellitus â?? type II for 1-15 years. 3. Diabetics with HbA1c >7.5%
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to any of the study treatments, excipients, or drugs of similar chemical classes including sulfonylureas and meglitinides 2. History of type 1 diabetes 3. Subjects on insulin therapy 4. Subjects with the history of uncontrolled hypertension and/or hyperthyroidism 5. History of alcoholism 6. Subjects with psychiatric or neurological disability or mental health disorder 7. Subjects with serious health conditions such as cardiac disease, renal dysfunction, and cancers. 8. Female subjects who are pregnant or had planned for pregnancy in the following months or were breast-feeding. 9. Subjects who refuse to sign informed consent. 10. Those who have participated in another clinical trial within 1 month of visit 1 or plan to participate during the clinical trial period. 11. According to the investigatorâ??s opinion, participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable. 12. Any planned surgery during study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Fasting Blood Sugar Test 2. Post-prandial blood glucoseTimepoint: 1. Baseline on day 1 and day 2 2. At 1 hr and 2 hr post each product consumption on day 1 and day 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of any AETimepoint: Day 1 and Day 2 | — |
Countries
India
Contacts
Public ContactSubham Dutta
Syncorp Health Pvt Ltd
Outcome results
None listed