PERFECT Project - Part 2 - 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) 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. We hypothesize that consumption of bagels 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. We also hypothesize that consumption of bagels 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 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 flour and pea fibre
* Other: Pea flour and pea protein
* Other: Pea flour + pea fibre + pea protein


Participation Criteria
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Eligibility Criteria
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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: Other
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 (30%) | Other: Pea flour<br>* Pulse ingredient bagel<br>|
| Experimental: Bagel with pea fibre<br>Pea fibre (11g) | Other: Pea fibre<br>* Pulse ingredient bagel<br>|
| Experimental: Bagel w/ pea flour + pea fibre<br>Pea flour (30%) + pea fibre (11g) | Other: Pea flour and pea fibre<br>* Pulse ingredient bagel<br>|
| Experimental: Bagel w/ pea flour + pea protein<br>Pea flour (30%) + pea protein (24g) | Other: Pea flour and pea protein<br>* Pulse ingredient bagel<br>|
| Experimental: Bagel w/ pea flour + pea fibre + pea protein<br>Pea flour (30%) + pea fibre (11g) + pea protein (24g) | Other: Pea flour + 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. Glucose will be determined by automated methods using Abbot Spectrum CCX Analyzer, and Insulin will be measured by commercially available RIA kits | 0-240 | 
| Food Intake | Ad-libitum meal | 120 min | 
| Subjective Appetite | Motivation-to-eat VAS questionnaire | 0-240 min | 
| Exercise intensity | Oxygen consumption measured during exercise at 3 time points | 60-120 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Palatability | Measured by VAS questionnaire | 5 and 260 min | 
| Physical comfort | Measured by VAS questionnaire | 0-240 min | 
| Energy/fatigue | Measured by VAS questionnaire | 0 - 240 min | 
| Heart rate | To monitor exercise intensity and give a measure of fatigue (cardiovascular drift) | 60-120 min | 
| Lactate concentration | Measured before, during, and exercise exercise at 3 time points | 60-120 min | 
| Substrate Oxidation | Respiratory quotient measured during exercise at 3 time points | 60-120 min |