Measuring the Glycemic Index of Pulse Based Breads

Study Overview
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Brief Summary
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The objective of this study is to determine the glycemic index of 4 pulse-based breads in at least 10 normal healthy human volunteers. Participants will be studied in the morning on 6 separate days after overnight fasts. On the first and last days they will consume a test meal consisting of about 2 slices of white bread (50g carbohydrate) and on the other 4 days they will consume 2-3 slices (50g carbohydrate) from 4 different test breads containing starch obtained from pulses (beans and/or lentils). Blood glucose will be measured at intervals over 2 hours. Glycemic index is calculated as 0.71 times F/WB where F is the incremental area under the curve of blood glucose (AUC) after each test bread and WB is the mean AUC after white bread.

Official Title
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Measuring the Glycemic Index of Pulse Based Breads

Conditions
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Carbohydrate Intolerance

Intervention / Treatment
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* Other: Bread


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: participants in good health Exclusion Criteria: known history of HIV known history of diabetes history of hepatitis within the last 3 months heart condition requiring hospitalization within 3 months use of medications or presence of any condition which in the opinion of the study physician, would increase the risk of harm to the subject or to others, or affect the results of the study. participants who cannot or will not comply with experimental procedures or the safety guidelines of Glycemic Index Laboratories, Inc.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: White Bread<br>Portion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber). | Other: Bread<br> <br> |
| Experimental: Pea Bread<br>Portion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber) containing 18% (by weight) pea flour. | Other: Bread<br> <br> |
| Experimental: Green Lentil Bread<br>Portion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber) containing 18% (by weight) green lentil flour. | Other: Bread<br> <br> |
| Experimental: Red Lentil Bread<br>Portion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber) containing 18% (by weight) red lentil flour. | Other: Bread<br> <br> |
| Experimental: Chickpea Bread<br>Portion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber) containing 18% (by weight) chickpea flour. | Other: Bread<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic Index | Glycemic index is 0.71 times F/WB where F is the incremental area under the blood glucose response curve ignoring area below fasting (AUC) elicited by a pulse bread, and WB is the mean AUC elicited by White Bread. AUC is calculated using the trapezoid rule from 2 measures of fasting blood glucose taken 5 minutes apart (the average of these measures is taken to be fasting blood glucose) and measures of blood glucose at 15, 30, 45, 60, 90 and 120 minutes after starting to eat. The mean of the values for each pulse bread in each subject is the glycemic index. | 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental area under the blood glucose response curve | Incremental area under the blood glucose response curve ignoring area below fasting (AUC) is calculated using the trapezoid rule from 2 measures of fasting blood glucose taken about 5 minutes apart (the average of these measures is taken to be fasting blood glucose) and measures of blood glucose at 15, 30, 45, 60, 90 and 120 minutes after starting to eat. | 120 minutes | 
| Peak blood glucose concentration (Cmax) | Cmax is the maximum of the blood glucose concentrations measured at 15, 30, 45, 60, 90 and 120 minutes after consumption of a test meal. | 120 minutes | 
| Peak rise of blood glucose | The maximum of the blood glucose concentrations measured at 15, 30, 45, 60, 90 and 120 minutes after consumption of a test meal minus the fasting blood glucose concentration. | 120 minutes |