PERFECT Project - Part 2 - Study 1

Not Applicable

Completed

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

• Registration Number: NCT02402517
• Lead Sponsor: University of Manitoba

Brief Summary

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.

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: 2014-12-17
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-30
• Study Start: 2015-08
• Status Verified: 2017-05
• Primary Completion: 2017-07
• Study Completion: 2017-12
• 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 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Subjective Appetite	0-240 min	Measured by VAS questionnaire at 14 time points, used to calculate area under curve (AUC).( Composite measure)
Exercise intensity	60 minutes	Sixty minute exercise protocol at minutes 60 to 120. Oxygen consumption measured during exercise at 3 time points.
Plasma Glucose and Insulin Concentrations	0 - 240 min	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)
Food Intake	at 120 min	Ad-libitum meal. Food consumed measured by weight.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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