PERFECT Project - Part 1 - Study 1

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Prevention; Obesity Prevention
• 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 (Actual): 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 45 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 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

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 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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Johnston AJ, Mollard RC, Dandeneau D, MacKay DS, Ames N, Curran J, Bouchard DR, Jones PJ. Acute effects of extruded pulse snacks on glycemic response, insulin, appetite, and food intake in healthy young adults in a double blind, randomized, crossover trial. Appl Physiol Nutr Metab. 2021 Jul;46(7):704-710. doi: 10.1139/apnm-2020-0572. Epub 2020 Dec 21.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: December 20, 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: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: B2014:114-1