PERFECT Project - Part 2 - Study 1

Study Overview
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Brief Summary
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The objectives are to test the acute effects of different extruded pulse snacks on: 1) aerobic endurance and substrate oxidation during exercise 2) response of blood glucose, insulin and appetite on an aerobic exercise session, and 3) food intake two hours following the exercise session. The investigators hypothesize that consumption of food products 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 extruded pulse snacks 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 1

Conditions
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Diabetes, Obesity

Intervention / Treatment
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* Other: Control
* Other: Small particle size pea flour
* Other: Large particle size pea flour
* Other: Lentil flour
* Other: Navy bean flour
* Other: Pinto bean flour


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: 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: Extruded snack control<br>100% corn flour | Other: Control<br>* Non pulse extruded snack<br>|
| Experimental: Extruded snack with small particle size pea flour<br>60% corn flour and 40% small particle size pea flour | Other: Small particle size pea flour<br>* Pulse extruded snack<br>|
| Experimental: Extruded snack with large particle size pea flour<br>60% corn flour and 40% large particle size pea flour | Other: Large particle size pea flour<br>* Pulse extruded snack<br>|
| Experimental: Extruded snack with lentil flour<br>60% corn flour and 40% lentil flour | Other: Lentil flour<br>* Pulse extruded snack<br>|
| Experimental: Extruded snack navy bean flour<br>60% corn flour and 40% navy bean flour | Other: Navy bean flour<br>* Pulse extruded snack<br>|
| Experimental: Extruded snack with pinto bean flour<br>60% corn flour and 40% pinto bean flour | Other: Pinto bean flour<br>* Pulse extruded snack<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 14 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. (Composite measure) | 0 - 240 min | 
| Food Intake | Ad-libitum meal. Food consumed measured by weight. | at 120 min | 
| Subjective Appetite | Measured by VAS questionnaire at 14 time points, used to calculate area under curve (AUC).( Composite measure) | 0-240 min | 
| Exercise intensity | Sixty minute exercise protocol at minutes 60 to 120. Oxygen consumption measured during exercise at 3 time points. | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactate concentration | 60 minute exercise protocol at minutes 60 to 120. Measured before, during, and exercise exercise at 3 time points | 60 minutes | 
| Palatability of treatments | Measured by VAS questionnaire | at 5 minutes | 
| Palatability of meal | Measured by VAS questionnaire | at 260 minutes | 
| Physical comfort | Measured by VAS questionnaire at 13 time points, used to calculate area under curve (AUC) (Composite measure) | 0-240 min | 
| Energy/fatigue | Measured by VAS questionnaire at 13 time points, used to calculate area under curve (AUC) (Composite measure) | 0-240 min | 
| Heart rate | Heart rate monitored over a 60 minute exercise protocol. To monitor exercise intensity and give a measure of fatigue (cardiovascular drift) | 60-120 min | 
| Substrate Oxidation | Measured during 60 minute exercise protocol at minutes 60-120. Respiratory quotient measured during exercise at 3 time points. | 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Prevention, Obesity Prevention