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Measuring the Glycemic Index of Pulse Based Breads

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03015506
Recruitment Status : Completed
First Posted : January 10, 2017
Last Update Posted : April 28, 2017
Sponsor:
Collaborator:
Agriculture and Agri-Food Canada
Information provided by (Responsible Party):
Glycemic Index Laboratories, Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Carbohydrate Intolerance Other: Bread Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Measuring the Glycemic Index of Pulse Based Breads
Study Start Date : January 2017
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017


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



Primary Outcome Measures :
  1. Glycemic Index [ Time Frame: 120 minutes ]
    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.


Secondary Outcome Measures :
  1. Incremental area under the blood glucose response curve [ Time Frame: 120 minutes ]
    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.

  2. Peak blood glucose concentration (Cmax) [ Time Frame: 120 minutes ]
    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.

  3. Peak rise of blood glucose [ Time Frame: 120 minutes ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015506


Sponsors and Collaborators
Glycemic Index Laboratories, Inc
Agriculture and Agri-Food Canada
Investigators
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Principal Investigator: Thomas MS Wolever, MD, PhD Glycemic Index Laboratories, Inc

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Responsible Party: Glycemic Index Laboratories, Inc
ClinicalTrials.gov Identifier: NCT03015506    
Other Study ID Numbers: 01E91-16-62508
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No