HyperglycemiaNCT02909803
Measuring the Glycemic Index and Tracking Metabolites of New and Emerging Lentil Varieties
A study testing Lentil Variety and White Bread in people with Hyperglycemia and Dietary Modification, run by Guelph Food Research Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia, Dietary Modification
- What is being tested?
- Lentil Variety and White Bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hyperglycemia, Dietary Modification
- Being tested
- Lentil Variety, White Bread
- Keywords
- glucose, glycemic index, lentil, polyphenols, metabolites, bioavailability
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lentil VarietyOther
Participants will consume 8 varieties of lentils that are cooked by boiling
White BreadOther
Participants will consume white bread on at least two different test days
| Study group | Role | What they receive |
|---|---|---|
| Lentil Variety | Experimental | 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 Receives: Other: Lentil Variety |
| White Bread | Active comparator | Each participant will consume a serving of white bread containing 25g available carbohydrate on two separate visits Receives: Other: White Bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 minutes after consuming each test or control food
Secondary outcomes (1)
Lentil metabolites in blood and urine
Samples will be preserved and analyzed for polyphenols (HPLC) and unknown metabolites using a non-targeted metabolomics approach.
Measured: Urine and additional 200uL blood samples will be collected before eating test meal and at 120 minutes after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startJan 2013
- Primary completionMar 2013
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guelph Food Research Centre
- Sponsor type
- Other government
- Collaborators
- Glycemic Index Laboratories, Inc, University of Manitoba
- Responsible party
- Principal investigator, Dan Ramdath, Guelph Food Research Centre
- Investigators
- Dan Ramdath, PhD, Principal investigator, Guelph Research and Development Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909803
- Sponsor's protocol ID
- Lentil metabolites
- Status last verified
- Sep 2016
- First submitted
- 15 Sep 2016
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 3942088Wolever 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.
PubMed 27497151Wang, 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 at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring the Glycemic Index and Tracking Metabolites of New and Emerging Lentil Varieties
- ClinicalTrials.gov ID
- NCT02909803
- Acronym / sponsor ID
- Lentil metabolites
- Conditions
- Hyperglycemia, Dietary Modification
- Keywords
- glucose, glycemic index, lentil, polyphenols, metabolites, bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Guelph Food Research CentreOther government
- Collaborators
- Glycemic Index Laboratories, Inc, University of Manitoba
- Study start
- Jan 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lentil Variety | Experimental | Other: Lentil VarietyEach 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 |
| White Bread | Active comparator | Other: White BreadEach participant will consume a serving of white bread containing 25g available carbohydrate on two separate visits |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lentil VarietyParticipants will consume 8 varieties of lentils that are cooked by boiling | Other | Lentil Variety |
| White BreadParticipants will consume white bread on at least two different test days | Other | White Bread |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
- BackgroundHealth 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
- Background: PubMed 3942088Wolever 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.
- BackgroundWolever TMS (2006). The Glycaemic Index: A Physiological Classification of Dietary Carbohydrate. CABI Publishing, Wallingford, UK.
- Background: PubMed 27497151Ramdath 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.
- BackgroundWang, 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Ramdath, PhD principal investigator
Guelph Research and Development Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lentil Variety and White Bread in people with Hyperglycemia and Dietary Modification, run by Guelph Food Research Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Response (time frame: 120 minutes after consuming each test or control food). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02909803, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2016.