Measuring the Glycemic Index of Pulse Based Breads

Carbohydrate Intolerance Clinical Trial

Official title:

Measuring the Glycemic Index of Pulse Based Breads

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015506
• Other study ID #: 01E91-16-62508
• Status: Completed
• Phase: N/A
• First received: January 6, 2017
• Last updated: April 26, 2017
• Start date: January 2017
• Est. completion date: March 2017

Study information

• Verified date: January 2017
• Source: Glycemic Index Laboratories, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carbohydrate Intolerance

Intervention

Other:
• Bread

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Glycemic Index Laboratories, Inc	Agriculture and Agri-Food Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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