PERFECT Project - Part 2 - Study 2
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 2
1 other identifier
interventional
30
1 country
1
Brief Summary
The objectives are to test the acute effects of different cereals containing pulse ingredients on: 1) aerobic endurance and substrate oxidation during exercise 2) response of blood glucose, insulin and appetite to an aerobic exercise session, and 3) food intake two hours following the exercise session. The investigators hypothesize that consumption of cereals 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 cereals containing pulse ingredients 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2014
CompletedFirst Posted
Study publicly available on registry
February 25, 2015
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJanuary 26, 2023
July 1, 2018
1.2 years
December 17, 2014
January 25, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
Plasma Glucose Concentrations
Measured in blood using intravenous catheter. Glucose will be determined by automated methods using Abbot Spectrum Clinical Chemistry-X Analyzer,
0-240 minutes
Food Intake
Ad-libitum meal
at 240 minutes
Subjective Appetite
Motivation-to-eat Visual Analog Scale questionnaire
0-240 minutes
Exercise intensity
Oxygen consumption measured during exercise at 3 time points
60-120 minutes
Insulin concentrations
Measured in blood using intravenous catheter. and Insulin will be measured by commercially available radioimmunoassay (RIA) kits
0-240 minutes
Secondary Outcomes (6)
Palatability measured by Visual Analog Scale questionnaire
5 and 260 minutes
Physical comfort measured by Visual Analog Scale questionnaire
0-240 minutes
Energy/fatigue measured by Visual Analog Scale questionnaire
0 - 240 minutes
Heart rate
60-120 minutes
Substrate Oxidation
60-120 minutes
- +1 more secondary outcomes
Study Arms (6)
Control
PLACEBO COMPARATOR100% Wheat Flour
Cereal w/ pea protein
EXPERIMENTALPea protein
Cereal w/ pea starch
EXPERIMENTALPea starch
Cereal w/ pea starch + pea fibre
EXPERIMENTALPea starch + pea fibre: 5g
Cereal w/ pea protein + pea starch
EXPERIMENTALPea protein + pea starch: 10g
Cereal w/ pea protein + pea fibre + pea starch:
EXPERIMENTALPea protein + pea fibre + pea starch: 20g
Interventions
Pulse extruded cereal
Eligibility Criteria
You may qualify if:
- Normoglycemic (\<5.6 mmol/L) and normotensive (systolic blood pressure \<140 mm Hg and diastolic blood pressure below \< 90 mm Hg)
- Body Mass Index of 18.5-29.9 kg/m2
You may not qualify if:
- 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
- Those who are active (organized activities or athletic training at a high intensity; ≥ 150 minutes per week of moderate to vigorous physical activity)
- Those unable to walk for an hour continuously
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Manitobalead
- Saskatchewan Pulse Growerscollaborator
- Alberta Pulse Growerscollaborator
Study Sites (1)
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, R3T 2N2, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter JH Jones, PhD
University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2014
First Posted
February 25, 2015
Study Start
May 1, 2016
Primary Completion
July 1, 2017
Study Completion
December 1, 2017
Last Updated
January 26, 2023
Record last verified: 2018-07