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

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.

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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