None listed
Conditions
Interventions
Intervention1: NutriChoice Advanced Ragi Cookies(Formerly known as NutriChoice Ragi Cookies): 25 g available carbohydrates providing biscuit will be given to study participants as test food. Single Co
Sponsors
Britannia Industries Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Healthy, adult male and non-pregnant/non-lactating female participants between the ages of 18 to 45 years both inclusive at the time of consent. 2) Participants having fasting blood glucose levels below100 mg/dL. 3) Participants having HbA1c level below 5.7 % 4) Participants with Body Mass Index of 18.5 to 22.9 kg/m2 (both inclusive). 5) Female participants of childbearing potential must have a negative urine pregnancy test performed during screening. 6) Participants who agree to refrain from vigorous physical exercise during the study period. 7) Participants with no medications known to affect glucose tolerance (excluding oral contraceptives) stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins and mineral supplements or drugs to treat hypertension or osteoporosis. 8) Participants with no history of cardiovascular disease. 9) Participants who have not donated blood within 30 days prior to screening.
Exclusion criteria
Exclusion criteria: 1) Participants with any known food allergy or intolerance to any food or beverages. 2) Participants with allergies to wheat, gluten, dairy, or other common biscuit ingredients. 3) Participants with presence of any chronic disease or illness in the past three months or any clinically significant on-going chronic medical illness e.g., Congestive cardiac failure, Hepatitis, Hypotensive episodes, etc. 4) Participants with recent history of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to the study. 5) Participants who have participated in any clinical trial within the past 90 days with blood loss more than 450 mL. 6) Participants who are on an unusual diet, special diet, for whatever reason e.g., high protein diet, low sodium diet, intermittent fasting for two weeks prior to receiving any reference/test product and throughout participant s participation in the study. 7) Participants who have tested positive for HIV test 8) Participants having history of Hepatitis B or C virus. 9) Participants with a known history of diabetes mellitus or the use of anti-hyperglycaemic drugs or insulin to treat diabetes and related conditions. 10) Participants with the presence of disease or drug(s) which influence digestion and absorption of nutrients. 11) Participants with the use of steroids, protease inhibitors or antipsychotics (all of which have major effects on glucose metabolism and body fat distribution). 12) Participants with a history of significant gastrointestinal disorders (e.g., inflammatory bowel disease, gastroparesis) that could affect absorption or digestion.) 13) Participants with any known kidney or liver disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the glycemic index of test products, in healthy participants.Timepoint: 5 mins prior to product administration, 0 min and 15, 30, 45, 60, 90 and 120 minutes post product administration on each product administration day. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of Satiety level using an equilateral 7-point rating scale.Timepoint: 5 mins prior to product administration, 0 min and 15, 30, 60, 90, 120, 180 and 240 minutes post product administration on each product administration day. | — |
Countries
India
Contacts
Public ContactMs Manasa P S
Cliantha Research
Outcome results
None listed