Health Condition 1: E70-E88- Metabolic disorders
Conditions
Interventions
Intervention1: Arm 2-Foxtail Millet: Foxtail Millet-based food product, which is equivalent to 25 g of available carbohydrate, served with 200 ml of water.
Intervention2: Arm 3(Foxtail Millet + Ash):
Sponsors
CLINISYD RESEARCH GLOBAL SOLUTIONS PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1 Adult age group of 25 to 59 years Subjects, diagnosed with prediabetes as per ADA , both male and female subjects inclusive. 2 Adults Diagnosed with prediabetes 3 Fasting blood glucose levels of 100 to 125 mg per dL as per American Diabetes Association (ADA) And Glycosylated Haemoglobin (HbA1c) 5.7 to 6.4 percentage as per American Diabetes Association (ADA) 4.BMI should be between 18.5 to 24.9 kg per m2 5.Lipid profile (Total cholesterol) within normal range as applicable 6.Must be willing to give written informed consent and comply with the study procedures.6.-Subject?s complete blood count parameters to be within clinically acceptable range as per the discretion by Investigator. 7.Not on antidiabetic medication
Exclusion criteria
Exclusion criteria: 1.Total cholesterol higher than normal range. 2.Subjects particularly on any special diet 3.Subjects suffering from any systemic disorders (diabetes mellitus, cardiovascular, renal, pulmonary, endocrine, or neurological disorders, ulcers, dermatologic disorders, autoimmune diseases) or severe food allergies; an active infectious disease (HBV, HCV, HIV) 4. current diagnosis or a history of relevant depressive episodes or of panic attacks, psychosis, bipolar or eating disorders 5.have special dietary restrictions or food allergies that would prohibit consumption of a variety of foods/beverages; 6.Patient having participated in any other clinical trial within one month prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess glycemic index using blood sugar levels measured at fixed intervals. Timepoint: At fixed intervals (-5, 15, 30, 45, 60, 90 and 120 min) in a day with respect to reference product | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the Glycaemic Index(GI) of the test product assessing C-peptide levelsTimepoint: At -5min and after 120 min in a day with respect to reference product | — |
Countries
India
Contacts
Public ContactSudha Raj
Tumkur University ,Tumkur
Outcome results
None listed