Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: GLUBLOC Sachet: 1 gram powder sachet with GLUBLOC™ 350mg (a proprietary blend of Morus alba L and Malus domestica peel extracts) with Microcrystalline cellulose and Dibasic calcium phos
Sponsors
My Pura Vida Wellness Private Limited (Puravida)
Eligibility
Inclusion criteria
Inclusion criteria: Healthy subjects: 1.Aged between 18–60 years, 2.BMI between 18.5 and 22.9 kg/m2 3.Fasting blood glucose range between 3.9 and 5.5 mmol/L. Diabetes Patients 1.Aged between 18–60 years, 2.BMI between 18.5 and 29.9 kg/m2 3.Fasting blood glucose = 7.2 mmol/L (or) = 126 mg/dl or HbA1C = 6.5%
Exclusion criteria
Exclusion criteria: Healthy subjects: 1.Women who were pregnant or lactating 2.Any known food allergies 3.Subjects with a bleeding disorder 4.Pre-existing medical condition or taking medication known to affect glucose regulation and/or influence digestion and absorption of nutrients 5.History of diabetes mellitus (type I/II) or they used antihyperglycaemic drugs or insulin to treat diabetes or related conditions 6.Used steroids, protease inhibitors or antipsychotic medicines as these drugs are known to impact glucose metabolism and body fat distribution. Diabetes Patients: 1.food allergies. 2.Used steroids, protease inhibitors or antipsychotic medicines as these drugs are known to impact glucose metabolism and body fat distribution. 3.Subjects with the history of uncontrolled hypertension and/or hyperthyroidism. 4.History of alcoholism 5.Subjects with psychiatric or neurological disability or mental health disorder 6.Subjects with serious health conditions such as cardiac disease, renal dysfunction, and cancers. 7.Female subjects who are pregnant or had planned for pregnancy in the following months or were breast-feeding. 8.Subjects who refuse to sign informed consent. 9.According to the investigator’s opinion, participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To document the impact of GLUBLOC supplementation in patients with diabetes and healthy individualsTimepoint: Baseline samples before intervention, end of the 3rd Month and end of the six month | — |
Secondary
| Measure | Time frame |
|---|---|
| To document adverse effect if any on study productTimepoint: Baseline samples before intervention, end of the 3rd Month and end of the six month | — |
Countries
India
Contacts
Public ContactBalamurugan Ramadass
All India Institute of Medical Sciences
Outcome results
None listed