PERFECT Project - Part 1 - Study 3

Study Overview
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Brief Summary
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The objectives are to test the acute effects of different bagels containing pulse ingredients on: 1) post-prandial blood glucose, insulin and appetite for two hours, and 2) food intake two hours following consumption of pulse products. The investigators hypothesize that bagels containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake responses compared to non-pulse bagels.

Official Title
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Pulse EnRiched Food and Exercise Clinical Trials (PERFECT Project): Part 1 - Acute Effects of Pulse Ingredients in Snack Products on Appetite, Blood Glucose, and Food Intake in Adults - Study 3

Conditions
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Diabetes Prevention, Obesity Prevention

Intervention / Treatment
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* Other: Control
* Other: Pea flour
* Other: Pea fibre
* Other: Pea protein
* Other: Pea flour + pea protein
* Other: Pea fibre + pea protein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normoglycemic (<5.6 mmol/L) and normotensive (systolic blood pressure <140 mm Hg and diastolic blood pressure below < 90 mm Hg) BMI of 18.5-29.9 kg/m2 Exclusion Criteria: Restrained eaters Regularly skip breakfast Smokers Those who are active (organized activities or athletic training at a high intensity; ≥ 150 min per week of moderate to vigorous physical activity) Those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year. Those unable to walk for an hour continuously

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bagel control<br>100% wheat flour | Other: Control<br>* Non pulse ingredient bagel<br>|
| Experimental: Bagel with pea flour<br>Pea flour | Other: Pea flour<br>* Pulse ingredient bagel<br>|
| Experimental: Bagel with pea fibre<br>Pea fibre | Other: Pea fibre<br>* Pulse ingredient bagel<br>|
| Experimental: Bagel with pea protein<br>Pea protein | Other: Pea protein<br>* Pulse ingredient bagel<br>|
| Experimental: Bagel with pea flour + pea protein<br>Pea flour + pea protein | Other: Pea flour + pea protein<br>* Pulse ingredient bagel<br>|
| Experimental: Bagel with pea fibre + pea protein<br>Pea fibre + pea protein | Other: Pea fibre + pea protein<br>* Pulse ingredient bagel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Glucose and Insulin Concentrations | Measured in blood using intravenous catheter at 12 time points used to calculate area under curve (AUC). Glucose will be determined by automated methods using Abbot Spectrum CCX Analyzer, and Insulin will be measured by commercially available RIA kits | 0-200 | 
| Food Intake | Ad-libitum meal. Food consumed measured by weight | at 120 min | 
| Subjective Appetite | Motivation-to-eat VAS questionnaire used to calculate area under curve (AUC) | 0-200 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Palatability of meal | Measured by VAS questionnaire | at 140 mins | 
| Palatability of treatments | Measured by VAS questionnaire | at 5 mins | 
| Physical comfort | Measured by VAS questionnaire at 12 time points used to calculate area under curve (AUC) | 0 - 200 min | 
| Energy/fatigue measured by VAS questionnaire | Measured by VAS questionnaire at 12 time points, used to calculate area under curve (AUC) | 0 - 200 mins |