- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02365363
PERFECT Project - Part 2 - Study 3
January 19, 2023 updated by: University of Manitoba
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 3
The objectives are to test the acute effects of different bagels 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.
We hypothesize that consumption of bagels 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.
We also hypothesize that consumption of bagels 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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3T 6C5
- Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bagel control
100% wheat flour
|
Non pulse ingredient bagel
|
Experimental: Bagel with pea flour
Pea flour (30%)
|
Pulse ingredient bagel
|
Experimental: Bagel with pea fibre
Pea fibre (11g)
|
Pulse ingredient bagel
|
Experimental: Bagel w/ pea flour + pea fibre
Pea flour (30%) + pea fibre (11g)
|
Pulse ingredient bagel
|
Experimental: Bagel w/ pea flour + pea protein
Pea flour (30%) + pea protein (24g)
|
Pulse ingredient bagel
|
Experimental: Bagel w/ pea flour + pea fibre + pea protein
Pea flour (30%) + pea fibre (11g) + pea protein (24g)
|
Pulse ingredient bagel
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective Appetite
Time Frame: 0-240 min
|
Motivation-to-eat VAS questionnaire
|
0-240 min
|
Exercise intensity
Time Frame: 60-120 min
|
Oxygen consumption measured during exercise at 3 time points
|
60-120 min
|
Plasma Glucose and Insulin Concentrations
Time Frame: 0-240
|
Measured in blood using intravenous catheter.
Glucose will be determined by automated methods using Abbot Spectrum CCX Analyzer, and Insulin will be measured by commercially available RIA kits
|
0-240
|
Food Intake
Time Frame: 120 min
|
Ad-libitum meal
|
120 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate
Time Frame: 60-120 min
|
To monitor exercise intensity and give a measure of fatigue (cardiovascular drift)
|
60-120 min
|
Substrate Oxidation
Time Frame: 60-120 min
|
Respiratory quotient measured during exercise at 3 time points
|
60-120 min
|
Palatability
Time Frame: 5 and 260 min
|
Measured by VAS questionnaire
|
5 and 260 min
|
Physical comfort
Time Frame: 0-240 min
|
Measured by VAS questionnaire
|
0-240 min
|
Energy/fatigue
Time Frame: 0 - 240 min
|
Measured by VAS questionnaire
|
0 - 240 min
|
Lactate concentration
Time Frame: 60-120 min
|
Measured before, during, and exercise exercise at 3 time points
|
60-120 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Actual)
December 19, 2017
Study Completion (Actual)
December 19, 2017
Study Registration Dates
First Submitted
December 17, 2014
First Submitted That Met QC Criteria
February 10, 2015
First Posted (Estimate)
February 18, 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
- B2014:114-6
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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