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Measuring the Glycemic Index of Pulse Based Breads

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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

Tracking Information
First Submitted Date  ICMJE January 6, 2017
First Posted Date  ICMJE January 10, 2017
Last Update Posted Date April 28, 2017
Study Start Date  ICMJE January 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2017)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Measuring the Glycemic Index of Pulse Based Breads
Official Title  ICMJE Measuring the Glycemic Index of Pulse Based Breads
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Carbohydrate Intolerance
Intervention  ICMJE Other: Bread
Study Arms  ICMJE
  • Active Comparator: White Bread
    Portion of bread containing 50g available carbohydrate (defined as total carbohydrate minus dietary fiber).
    Intervention: 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: Other: Bread
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2017)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03015506
Other Study ID Numbers  ICMJE 01E91-16-62508
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Glycemic Index Laboratories, Inc
Study Sponsor  ICMJE Glycemic Index Laboratories, Inc
Collaborators  ICMJE Agriculture and Agri-Food Canada
Investigators  ICMJE
Principal Investigator: Thomas MS Wolever, MD, PhD Glycemic Index Laboratories, Inc
PRS Account Glycemic Index Laboratories, Inc
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP