PERFECT Project - Part 2 - 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) aerobic endurance and substrate oxidation during exercise 2) response of blood glucose, insulin and appetite to an aerobic exercise session, and 3) food intake two hours following the exercise session. The investigators hypothesize that consumption of cereals containing pulse ingredients 60 minutes before exercise will increase aerobic endurance (lower oxygen consumption), decrease carbohydrate oxidation (greater respiratory quotient), and a reduction in lactate production during compared to the same exercise session following the ingestion of a non-pulse food. The investigators also hypothesize that consumption of cereals containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake, suggesting lower calorie compensation, following a 60-minute aerobic exercise session compared to the same exercise session following the ingestion of a non-pulse food.

Official Title
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Pulse EnRiched Food and Exercise Clinical Trials (PERFECT Project): Part 2 - Acute Effects of Pulse Ingredients in Food Products on Aerobic Endurance and Substrate Oxidation During Exercise, as Well as, the Blood Glucose, Insulin, Lactate and Food Intake Response Following an Endurance Exercise Session 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) Body Mass Index of 18.5-29.9 kg/m2 Exclusion Criteria: Restrained eaters Regularly skip breakfast Smokers Those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year Those who are active (organized activities or athletic training at a high intensity; ≥ 150 minutes per week of moderate to vigorous physical activity) Those unable to walk for an hour continuously

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Control<br>100% Wheat Flour | Other: Control<br>* Non pulse extruded cereal<br>|
| Experimental: Cereal w/ pea protein<br>Pea protein | Other: Pea protein<br>* Pulse extruded cereal<br>|
| Experimental: Cereal w/ pea starch<br>Pea starch | Other: Pea Starch<br>* Pulse extruded cereal<br>|
| Experimental: Cereal w/ pea starch + pea fibre<br>Pea starch + pea fibre: 5g | Other: Pea fibre + pea starch<br>* Pulse extruded cereal<br>|
| Experimental: Cereal w/ pea protein + pea starch<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:<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 Concentrations | Measured in blood using intravenous catheter. Glucose will be determined by automated methods using Abbot Spectrum Clinical Chemistry-X Analyzer, | 0-240 minutes | 
| Food Intake | Ad-libitum meal | at 240 minutes | 
| Subjective Appetite | Motivation-to-eat Visual Analog Scale questionnaire | 0-240 minutes | 
| Exercise intensity | Oxygen consumption measured during exercise at 3 time points | 60-120 minutes | 
| Insulin concentrations | Measured in blood using intravenous catheter. and Insulin will be measured by commercially available radioimmunoassay (RIA) kits | 0-240 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Palatability measured by Visual Analog Scale questionnaire | Food tasting | 5 and 260 minutes | 
| Physical comfort measured by Visual Analog Scale questionnaire | Contributions from energy intake | 0-240 minutes | 
| Energy/fatigue measured by Visual Analog Scale questionnaire | Estimate of energy expenditure | 0 - 240 minutes | 
| Heart rate | To monitor exercise intensity and give a measure of fatigue (cardiovascular drift) | 60-120 minutes | 
| Substrate Oxidation | Respiratory quotient measured during exercise at 3 time points | 60-120 minutes | 
| Lactate concentration | Measured before, during, and after exercise exercise at 3 time points | 60-120 minutes |