Measuring the Glycemic Index of Pulse Based Breads

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.

Study Overview

• Status: Completed
• Conditions: Carbohydrate Intolerance
• Intervention / Treatment: Other: Bread

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Glycemic Index Laboratories, Inc
• Collaborators: Agriculture and Agri-Food Canada

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: January 6, 2017
• First Submitted That Met QC Criteria: January 9, 2017
• First Posted (Estimate): January 10, 2017

Study Record Updates

• Last Update Posted (Actual): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 01E91-16-62508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No