Measuring the Glycemic Index and Tracking Metabolites of New and Emerging Lentil Varieties
Primary Purpose
Hyperglycemia, Dietary Modification
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lentil Variety
White Bread
Sponsored by
About this trial
This is an interventional basic science trial for Hyperglycemia focused on measuring glucose, glycemic index, lentil, polyphenols, metabolites, bioavailability
Eligibility Criteria
Inclusion Criteria:
- Male or non-pregnant females, 18-75 years of age, inclusive
- Body mass index (BMI) < 40 kg/m²
- Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial and to refrain from smoking for 12hr prior to each visit.
- Normal fasting serum glucose (<7.0mmol/L capillary corresponding to whole blood glucose <6.3mmol/L).
- Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
Exclusion Criteria:
- Failure to meet any one of the inclusion criteria
- Known history of AIDS, hepatitis, diabetes or a heart condition
- Subjects using medications or with any condition which might, in the opinion of Dr. Wolever, the Medical Director of GI Labs, either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
- Major trauma or surgical event within 3 months of screening.
- Unwillingness or inability to comply with the experimental procedures and to follow GI Labs safety guidelines.
- Known intolerance, sensitivity or allergy to any ingredients in the study products.
Sites / Locations
- Glycemic Index Laboratories, Inc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lentil Variety
White Bread
Arm Description
Each participant will consume a serving of one of eight lentil varieties (Greenland; Improve; Impower; Imigreen; Asterix; Redberry; Redcliff; Redbow) containing 25g available carbohydrate at separate study visits
Each participant will consume a serving of white bread containing 25g available carbohydrate on two separate visits
Outcomes
Primary Outcome Measures
Glycemic Response
Incremental blood glucose response after eating the test or control foods will be measured over a period of 120 minutes using finger prick blood samples collected at time 0, 15, 30, 45, 60, 90, 120 minutes.
Secondary Outcome Measures
Lentil metabolites in blood and urine
Samples will be preserved and analyzed for polyphenols (HPLC) and unknown metabolites using a non-targeted metabolomics approach.
Full Information
NCT ID
NCT02909803
First Posted
September 15, 2016
Last Updated
September 20, 2016
Sponsor
Guelph Food Research Centre
Collaborators
Glycemic Index Laboratories, Inc, University of Manitoba
1. Study Identification
Unique Protocol Identification Number
NCT02909803
Brief Title
Measuring the Glycemic Index and Tracking Metabolites of New and Emerging Lentil Varieties
Official Title
Measuring the Glycemic Index and Tracking Metabolites of New and Emerging Lentil Varieties
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guelph Food Research Centre
Collaborators
Glycemic Index Laboratories, Inc, University of Manitoba
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
It is not known whether different lentil varieties have the same efficacy in lowering blood glucose. Similarly, the carbohydrate component of lentils responsible for lowering blood glucose is not known, nor is the bioavailability of lentil metabolites and polyphenol bioactive.
Detailed Description
The overall aim of this work is to produce credible evidence for substantiating a food health claim for post prandial blood glucose lowering by lentil. Although several studies have shown that lentil consumption results in a lowering of post prandial blood glucose, it is not known whether different lentil varieties have the same efficacy. Similarly, the carbohydrate component of lentils responsible for lowering blood glucose is not known, nor is the bioavailability of lentil metabolites and polyphenol bioactive. The investigators hypothesize that the slowly digestible starch content of lentil is inversely related to in vivo glycemic response. The specific aims of this study are: (i) to identify the putative component(s) in lentil that might account for its blood glucose lowering effect, and (ii) to identify differences in blood glucose reduction among lentil varieties. These aims will be achieved in a three-step process. Firstly, in vitro studies will be pursued to determine the carbohydrate fractions of 20 new and emerging Canadian lentil varieties. Secondly, these results will be used to choose 8 lentil varieties with different slowly digestible starch content for a human Glycemic Index study. Thirdly, identification of lentil metabolites will be achieved by collecting extra capillary blood (200uL)and urine samples at fasting and 120min for measurement of polyphenols and metabolites using established HPLC and metabolomics techniques.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Dietary Modification
Keywords
glucose, glycemic index, lentil, polyphenols, metabolites, bioavailability
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lentil Variety
Arm Type
Experimental
Arm Description
Each participant will consume a serving of one of eight lentil varieties (Greenland; Improve; Impower; Imigreen; Asterix; Redberry; Redcliff; Redbow) containing 25g available carbohydrate at separate study visits
Arm Title
White Bread
Arm Type
Active Comparator
Arm Description
Each participant will consume a serving of white bread containing 25g available carbohydrate on two separate visits
Intervention Type
Other
Intervention Name(s)
Lentil Variety
Intervention Description
Participants will consume 8 varieties of lentils that are cooked by boiling
Intervention Type
Other
Intervention Name(s)
White Bread
Intervention Description
Participants will consume white bread on at least two different test days
Primary Outcome Measure Information:
Title
Glycemic Response
Description
Incremental blood glucose response after eating the test or control foods will be measured over a period of 120 minutes using finger prick blood samples collected at time 0, 15, 30, 45, 60, 90, 120 minutes.
Time Frame
120 minutes after consuming each test or control food
Secondary Outcome Measure Information:
Title
Lentil metabolites in blood and urine
Description
Samples will be preserved and analyzed for polyphenols (HPLC) and unknown metabolites using a non-targeted metabolomics approach.
Time Frame
Urine and additional 200uL blood samples will be collected before eating test meal and at 120 minutes after.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or non-pregnant females, 18-75 years of age, inclusive
Body mass index (BMI) < 40 kg/m²
Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial and to refrain from smoking for 12hr prior to each visit.
Normal fasting serum glucose (<7.0mmol/L capillary corresponding to whole blood glucose <6.3mmol/L).
Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
Exclusion Criteria:
Failure to meet any one of the inclusion criteria
Known history of AIDS, hepatitis, diabetes or a heart condition
Subjects using medications or with any condition which might, in the opinion of Dr. Wolever, the Medical Director of GI Labs, either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
Major trauma or surgical event within 3 months of screening.
Unwillingness or inability to comply with the experimental procedures and to follow GI Labs safety guidelines.
Known intolerance, sensitivity or allergy to any ingredients in the study products.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Ramdath, PhD
Organizational Affiliation
Guelph Research and Development Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glycemic Index Laboratories, Inc
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2N8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Health Canada. Bureau of Nutritional Sciences, food directorate, health products and food branch. June 2013. Draft guidance document on food health claims related to the reduction in post-prandial glycaemic response
Results Reference
background
PubMed Identifier
3942088
Citation
Wolever TM, Jenkins DJ. The use of the glycemic index in predicting the blood glucose response to mixed meals. Am J Clin Nutr. 1986 Jan;43(1):167-72. doi: 10.1093/ajcn/43.1.167.
Results Reference
background
Citation
Wolever TMS (2006). The Glycaemic Index: A Physiological Classification of Dietary Carbohydrate. CABI Publishing, Wallingford, UK.
Results Reference
background
PubMed Identifier
27497151
Citation
Ramdath D, Renwick S, Duncan AM. The Role of Pulses in the Dietary Management of Diabetes. Can J Diabetes. 2016 Aug;40(4):355-63. doi: 10.1016/j.jcjd.2016.05.015.
Results Reference
background
Citation
Wang, L., Zahradka, P., Taylor, C. and Aliani, M., Metabolomics Analysis of Serum and Urine After Bean Consumption by Patients with Peripheral Arterial Disease. The FASEB Journal, 30(1 Supplement): 682-10, 2016.
Results Reference
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Measuring the Glycemic Index and Tracking Metabolites of New and Emerging Lentil Varieties
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