Influence of breakfast cereal consumption on blood glucose release
Phase 1
Completed
- Registration Number
- CTRI/2018/04/013282
- Lead Sponsor
- Kellogg India Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
Inclusion Criteria
Normal healthy adult males in the age group of 18-45 years
BMI cut off â?? 18.5-24.9 kg/m2
Blood glucose level: 80-120mg/dl
Weight stable for last 3 months
Physical activity level less than 2.0
Normal renal and liver function
Subjects consuming low fibre (less than 10g) diet for last 3 days
Regular bowel movement
Exclusion Criteria
Insulin resistance
Diabetics or pre diabetics
Hb level - less than 13 mg/dl
Allergy to nuts, lactose intolerance
Subjects consuming greater than 120ml of alcohol on regular basis or consumed within 48 hrs of the experiment
Subjects consumed alcohol and tea or coffee 24 hour prior to the experiment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a) To assess glycemic response of cereal and milk based breakfast (test meal-1) against standard glucose drink by measuring blood glucose, insulin and C-peptide <br/ ><br>b) To assess glycemic response of cereal and milk based breakfast with added fruits and nuts (test meal-2) against standard glucose drink by measuring blood glucose, insulin and C-peptide <br/ ><br>Timepoint: Baseline - -5 mins <br/ ><br>Post meal - 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min, 180 min
- Secondary Outcome Measures
Name Time Method a)To assess diet induced thermogenesis (DIT) and substrate oxidation of test meal-1 and 2 against standard glucose test using indirect calorimetry <br/ ><br>b)To assess satiety level achieved by test meals against standard glucose test by measuring ghrelin levels and using the visual analogue scale <br/ ><br>Timepoint: a) For Energy expenditure and substrate utilisation - <br/ ><br>-15 min, 30 min, 60 min, 90 min, 120 min, 180 min <br/ ><br>b) Assessing satiety using VAS - -5 min, 10 min, 40 min, 70 min, 100 min, 130 min, 160 min, 190 min <br/ ><br> <br/ ><br>Ghrelin measurement - 5 min, 15 min, 30 min, 60 min, 90 min, 120 min