PERFECT Project - Part 1 - Study 2

Study Overview
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Brief Summary
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The objectives are to test the acute effects of different cereals 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. We hypothesize that cereals containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake responses compared to non-pulse cereals.

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 2

Conditions
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Diabetes Prevention, Obesity Prevention

Intervention / Treatment
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* Other: Control
* Other: Pea protein
* Other: Pea starch
* Other: Pea fibre + pea starch
* Other: Pea protein + pea starch
* Other: Pea fibre + pea starch + 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 Competitive sports or athletic training at a high intensity 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 |
| --- | --- |
| Placebo Comparator: Cereal control<br>100% Wheat Flour | Other: Control<br>* Non pulse extruded cereal<br>|
| Experimental: Cereal with pea protein<br>Pea protein | Other: Pea protein<br>* Pulse extruded cereal<br>|
| Experimental: Cereal with pea starch<br>Pea starch | Other: Pea starch<br>* Pulse extruded cereal<br>|
| Experimental: Cereal w/ pea starch + pea fibre: 5g<br>Pea starch + pea fibre: 5g | Other: Pea fibre + pea starch<br>* Pulse extruded cereal<br>|
| Experimental: Cereal w/ pea protein + pea starch: 10g<br>Pea protein + pea starch: 10g | Other: Pea protein + pea starch<br>* Pulse extruded cereal<br>|
| Experimental: Cereal w/ pea protein + pea fibre + pea starch: 20g<br>Pea protein + pea fibre + pea starch: 20g | Other: Pea fibre + pea starch + pea protein<br>* Pulse extruded cereal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Glucose and Insulin Concentrations | Glucose will be determined by automated methods using Abbot Spectrum CCX Analyzer, and Insulin will be measured by commercially available RIA kits | 0 - 200 min | 
| Food Intake | Measured by VAS questionnaire | at 120 min | 
| Subjective Appetite | Motivation-to-eat VAS questionnaire | 0-200 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Palatability of treaments and meal | Measured by VAS questionnaire | 5 and 140 minutes | 
| Physical comfort | Measured by VAS questionnaire | 0 - 200 min | 
| Energy/fatigue | Measured by VAS questionnaire | 0-200 min |