Postprandial Blood Glucose and Insulin Levels Following Consumption of Lentil-containing Food Products

Study Overview
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Brief Summary
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This study will recruit 20 healthy adults (male and female) to complete 9 study visits where they will consume different food products (chili, soup and muffin) with or without lentils incorporated into the them. Blood samples will be obtained by finger prick before and for 2 hours after the meal and analyzed for glucose and insulin.

Detailed Description
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The purpose of the current study is to determine the effects of lentil-containing food products on postprandial blood glucose and insulin levels in healthy premenopausal women and men aged 18-40 years old.This study will use a randomized crossover design. Participants will complete a series of 9 study visits during which participants will consume 9 study treatment meals consisting of muffins, soup and chilli, with and without lentils. Participants will then have their blood sampled for the following 2 hours by finger prick. Participants will remain seated during the test period. All study visits will occur at the Human Nutraceutical Research Unit and be separated by a washout period of 3-7 days. Throughout the study, it will be asked that participants' lifestyle and physical activity remain unchanged. Participants will be instructed to not start any new dietary approaches, and to not start any new natural health products (unless instructed by a physician).

Official Title
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The Love of Lentils (LoL) Study - Phase 2: The Effect of Acute Consumption of Lentil-containing Food Products on Post-prandial Blood Glucose and Insulin in Healthy Adults

Conditions
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Postprandial Glycemia in Healthy Adults

Intervention / Treatment
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* Other: Muffin: 25g available carbohydrate from small green lentil
* Other: Muffin: 25g available carbohydrate from split red lentil
* Other: Wheat muffin
* Other: Soup: 25g available carbohydrate from small green lentil
* Other: Soup: 25g available carbohydrate from split red lentil
* Other: Potato soup
* Other: Chili: 25g available carbohydrate from small green lentil
* Other: Chili: 25g available carbohydrate from split red lentil
* Other: Rice chili


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy men and women Age 18-40 years (aiming for equal distribution among 18-29, 30-40 years of age) BMI 20-30 kg/m2 Exclusion Criteria: Diabetes (fasting blood glucose ≥7.0 mmol/L and/or 2hr blood glucose >11.1 mmol/L post-75g OGTT) 1 Impaired Glucose Tolerance (IGT) (Fasting blood glucose 6.1-6.9 mmol/L and/or 2hr blood glucose 7.8-11.0 mmol/L post-75g OGTT) 1 Blood pressure >140/90 mm Hg Any major medical condition including a history of AIDS or hepatitis Medical or surgical event requiring hospitalization within 3 months of randomization Any medications except a stable dose (3 months) of oral contraceptives, blood pressure or statin medications Natural health products (NHPs) used for glycemic control (all other NHPs okay as long as table for 3 months) Tobacco use Probiotic supplement use Dietary fibre supplement use Pulse consumption >4 servings per week Food allergy or non-food life threatening allergy Alcohol consumption >14 drinks/week or >4 drinks/sitting Recent or intended significant weight loss or gain (>4 kg in previous 3 months) Elite athletes Shift workers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Small Green Lentil Muffin<br>Muffin: 25g available carbohydrate from small green lentil | Other: Muffin: 25g available carbohydrate from small green lentil<br>* Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.<br>|
| Experimental: Split Red Lentil Muffin<br>Muffin: 25g available carbohydrate from split red lentil | Other: Muffin: 25g available carbohydrate from split red lentil<br>* Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.<br>|
| Placebo Comparator: Wheat Muffin<br>Muffin: 25g available carbohydrate from wheat | Other: Wheat muffin<br>* Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.<br>|
| Experimental: Small Green Lentil Soup<br>Soup: 25g available carbohydrate from small green lentil | Other: Soup: 25g available carbohydrate from small green lentil<br>* Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.<br>|
| Experimental: Split Red Lentil Soup<br>Soup: 25g available carbohydrate from split red lentil | Other: Soup: 25g available carbohydrate from split red lentil<br>* Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.<br>|
| Placebo Comparator: Potato Soup<br>Soup: 25g available carbohydrate from potato | Other: Potato soup<br>* Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.<br>|
| Experimental: Small Green Lentil Chili<br>Chili: 25g available carbohydrate from small green lentil | Other: Chili: 25g available carbohydrate from small green lentil<br>* Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.<br>|
| Experimental: Split Red Lentil Chili<br>Chili: 25g available carbohydrate from split red lentil | Other: Chili: 25g available carbohydrate from split red lentil<br>* Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.<br>|
| Placebo Comparator: Rice Chili<br>Chili: 25g available carbohydrate from rice | Other: Rice chili<br>* Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial blood glucose |  | 2 hours postprandial | 
| Postprandial plasma insulin |  | 2 hours postprandial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Lentils, Pulses, Postprandial glycemia