PERFECT Project - Part 1 - Study 1

Not Applicable

Completed

• Conditions: Obesity Prevention; Diabetes Prevention
• Interventions: Other: Pinto bean flour; Other: Small particle size pea flour; Other: Control; Other: Navy bean flour; Other: Lentil flour; Other: Large particle size pea flour

• Registration Number: NCT02402504
• Lead Sponsor: University of Manitoba

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-12-20
• Study Start: 2015-03
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-30
• Primary Completion: 2016-07
• Study Completion: 2017-12
• Status Verified: 2021-04
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Extruded snack with pinto bean flour	Pinto bean flour	60% corn flour and 40% pinto bean flour
Extruded snack with small particle size pea flour	Small particle size pea flour	60% corn flour and 40% small particle size pea flour
Extruded snack control	Control	100% corn flour
Extruded snack navy bean flour	Navy bean flour	60% corn flour and 40% navy bean flour
Extruded snack with lentil flour	Lentil flour	60% corn flour and 40% lentil flour
Extruded snack with large particle size pea flour	Large particle size pea flour	60% corn flour and 40% large particle size pea flour

Primary Outcome Measures

Name	Time	Method
Food Intake	at 120 min	Ad-libitum meal
Subjective Appetite	0-200 min	Measured by VAS questionnaire at 12 time points used to calculate area under curve (AUC) (Composite measure)
Plasma Glucose and Insulin Concentrations	0 - 200 min	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Richardson Centre for Functional Foods and Nutraceuticals; 🇨🇦 Winnipeg, Manitoba, Canada