- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02909803
Measuring the Glycemic Index and Tracking Metabolites of New and Emerging Lentil Varieties
September 20, 2016 updated by: Dan Ramdath, Guelph Food Research Centre
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
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Toronto, Ontario, Canada, M5C 2N8
- Glycemic Index Laboratories, Inc
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lentil Variety
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
|
Participants will consume 8 varieties of lentils that are cooked by boiling
|
|
Active Comparator: White Bread
Each participant will consume a serving of white bread containing 25g available carbohydrate on two separate visits
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Participants will consume white bread on at least two different test days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glycemic Response
Time Frame: 120 minutes after consuming each test or control food
|
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.
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120 minutes after consuming each test or control food
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lentil metabolites in blood and urine
Time Frame: Urine and additional 200uL blood samples will be collected before eating test meal and at 120 minutes after.
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Samples will be preserved and analyzed for polyphenols (HPLC) and unknown metabolites using a non-targeted metabolomics approach.
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Urine and additional 200uL blood samples will be collected before eating test meal and at 120 minutes after.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dan Ramdath, PhD, Guelph Research and Development Centre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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
- 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.
- Wolever TMS (2006). The Glycaemic Index: A Physiological Classification of Dietary Carbohydrate. CABI Publishing, Wallingford, UK.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
September 15, 2016
First Submitted That Met QC Criteria
September 20, 2016
First Posted (Estimate)
September 21, 2016
Study Record Updates
Last Update Posted (Estimate)
September 21, 2016
Last Update Submitted That Met QC Criteria
September 20, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lentil metabolites
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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