PERFECT Project - Part 2 - Study 1

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3T 2N2
      • Richardson Centre for Functional Foods and Nutraceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Extruded snack control; 100% corn flour	Other: Control; Non pulse extruded snack
Experimental: Extruded snack with small particle size pea flour; 60% corn flour and 40% small particle size pea flour	Other: Small particle size pea flour; Pulse extruded snack
Experimental: Extruded snack with large particle size pea flour; 60% corn flour and 40% large particle size pea flour	Other: Large particle size pea flour; Pulse extruded snack
Experimental: Extruded snack with lentil flour; 60% corn flour and 40% lentil flour	Other: Lentil flour; Pulse extruded snack
Experimental: Extruded snack navy bean flour; 60% corn flour and 40% navy bean flour	Other: Navy bean flour; Pulse extruded snack
Experimental: Extruded snack with pinto bean flour; 60% corn flour and 40% pinto bean flour	Other: Pinto bean flour; Pulse extruded snack

What is the study measuring?

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
Palatability of treatments	Measured by VAS questionnaire	at 5 minutes
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 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

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Saskatchewan Pulse Growers; Alberta Pulse Growers

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: December 17, 2014
• First Submitted That Met QC Criteria: March 24, 2015
• First Posted (Estimate): March 30, 2015

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Diabetes Prevention; Obesity Prevention
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: B2014:114-2