PERFECT Project - Part 1 - 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) 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 snack products containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake responses compared to non-pulse snack products.

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 1

Conditions
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Diabetes Prevention, Obesity Prevention

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 on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year Competitive sports or athletic training at a high intensity 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: 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 12 time points and 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 - 200 min | 
| Food Intake | Ad-libitum meal | at 120 min | 
| Subjective Appetite | Measured by VAS questionnaire at 12 time points used to calculate area under curve (AUC) (Composite measure) | 0-200 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Palatability of treatments | Measured by VAS questionnaire | at 5 minutes | 
| Palatability of meal | Measured by VAS questionnaire | at 140 minutes | 
| Energy and Fatigue | Measured by VAS questionnaire at 12 time points and use to calculate AUC. (Composite measure) | 0-200 min | 
| Physical Comfort | Measured by VAS questionnaire at 12 time points used to calculate area under curve (AUC). (Composite measure) | 0-200 min |