Health Condition 1: E889- Metabolic disorder, unspecified
Conditions
Interventions
Intervention1: Test Treatment: (Test Food Product providing 50 g available carbohydrates): Test Treatment: (Test Food Product providing 50 g available carbohydrates)
Study duration per subject: 7+1 d
Sponsors
Dr Nishesh Jain
Eligibility
Inclusion criteria
Inclusion criteria: Eligibility will be assessed at screening Participants must meet all of the following criteria 1 Adults aged 20 to 60 years inclusive 2 Documented diagnosis of type 2 diabetes mellitus (T2DM) for more than 1 year prior to screening 3 Body mass index (BMI) Thirty-five kilograms per square meter at the time of screening 4 Willing and able to comply with study procedures dietary restrictions and scheduled visits 5 Written informed consent obtained prior to any study related procedure
Exclusion criteria
Exclusion criteria: Participant meeting any of the following criteria will be considered ineligible for participating in the study 1 Current or recent use of insulin therapy 2 Treatment with systemic glucocorticoids 3 Presence of chronic medical conditions requiring ongoing treatment except stable oral antidiabetic therapy 4 Unstable diabetes or diabetes with severe acute or chronic complications 5 Regular intake of multivitamin and/or mineral supplements within the period immediately preceding screening 6 Known food allergy or hypersensitivity to any component of the Test Product or reference glucose solution 7 Current smokers or use of tobacco products 8 Pregnant or lactating women or women planning pregnancy during the study period 9 Alcohol consumption exceeding 14 units per week 10 Unintentional body weight loss More than ten percent within the 3 months preceding screening 11 Lack of motivation or anticipated non-compliance including inability to attend all required study visits 12 Any other condition which in the opinion of the Investigator, may compromise participant safety or interfere with study assessments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Endpoint 1 Glycemic Index (GI) Calculated as (iAUCtest/iAUCreference)Ã?100 where iAUC is the incremental area under the glucose response curve above baseline over 0â??120 minutes post-ingestion using the trapezoidal ruleTimepoint: Primary Efficacy Endpoint 1 Glycemic Index (GI) Calculated as (iAUCtest/iAUCreference)Ã?100 where iAUC is the incremental area under the glucose response curve above baseline over 0â??120 minutes post-ingestion using the trapezoidal rule At day 2 & 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoint 1 Peak Glucose (Cmax) & Time to Peak (Tmax) Measured over 0â??120 minutes post-ingestion of the test product 2 Mean difference in glucose AUC Calculated over 0â??120 minutes post-ingestion.(for test & reference product) 3 Continuous monitoring of the AE.Timepoint: Secondary Endpoint 1 Peak Glucose (Cmax) & Time to Peak (Tmax) Measured over 0â??120 minutes post-ingestion of the test product 2 Mean difference in glucose AUC Calculated over 0â??120 minutes post-ingestion.(for test & reference product) 3 Continuous monitoring of the AE. At day 1 to day 8 | — |
Countries
India
Contacts
Public ContactDrDevesh Kumar
Chandra Laxmi Hopital
Outcome results
None listed