Measuring the Glycemic Index and Tracking Metabolites of New and Emerging Lentil Varieties

Hyperglycemia Clinical Trial

Official title:

Measuring the Glycemic Index and Tracking Metabolites of New and Emerging Lentil Varieties

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02909803
• Other study ID #: Lentil metabolites
• Status: Completed
• Phase: N/A
• First received: September 15, 2016
• Last updated: September 20, 2016
• Start date: January 2013
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: Guelph Food Research Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Public Health Agency of Canada
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2016
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dietary Modification
• Hyperglycemia

Intervention

Other:
• Lentil Variety
Participants will consume 8 varieties of lentils that are cooked by boiling
• White Bread
Participants will consume white bread on at least two different test days

Locations

Country	Name	City	State
Canada	Glycemic Index Laboratories, Inc	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Guelph Food Research Centre	Glycemic Index Laboratories, Inc, University of Manitoba

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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

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. Review. — View 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.

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. — View Citation

Wolever TMS (2006). The Glycaemic Index: A Physiological Classification of Dietary Carbohydrate. CABI Publishing, Wallingford, UK.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	120 minutes after consuming each test or control food	No
Secondary	Lentil metabolites in blood and urine	Samples will be preserved and analyzed for polyphenols (HPLC) and unknown metabolites using a non-targeted metabolomics approach.	Urine and additional 200uL blood samples will be collected before eating test meal and at 120 minutes after.	No