PERFECT Project - Part 1 - Study 3

January 19, 2023 updated by: University of Manitoba

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 3

The objectives are to test the acute effects of different bagels containing pulse ingredients 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 bagels containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake responses compared to non-pulse bagels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

  • Canada
    • 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

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bagel control
100% wheat flour
Other: Control
Non pulse ingredient bagel
Experimental: Bagel with pea flour
Pea flour
Other: Pea flour
Pulse ingredient bagel
Experimental: Bagel with pea fibre
Pea fibre
Other: Pea fibre
Pulse ingredient bagel
Experimental: Bagel with pea protein
Pea protein
Other: Pea protein
Pulse ingredient bagel
Experimental: Bagel with pea flour + pea protein
Pea flour + pea protein
Other: Pea flour + pea protein
Pulse ingredient bagel
Experimental: Bagel with pea fibre + pea protein
Pea fibre + pea protein
Other: Pea fibre + pea protein
Pulse ingredient bagel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Glucose and Insulin Concentrations
Time Frame: 0-200
Measured in blood using intravenous catheter at 12 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
0-200
Food Intake
Time Frame: at 120 min
Ad-libitum meal. Food consumed measured by weight
at 120 min
Subjective Appetite
Time Frame: 0-200 min
Motivation-to-eat VAS questionnaire used to calculate area under curve (AUC)
0-200 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Palatability of meal
Time Frame: at 140 mins
Measured by VAS questionnaire
at 140 mins
Palatability of treatments
Time Frame: at 5 mins
Measured by VAS questionnaire
at 5 mins
Physical comfort
Time Frame: 0 - 200 min
Measured by VAS questionnaire at 12 time points used to calculate area under curve (AUC)
0 - 200 min
Energy/fatigue measured by VAS questionnaire
Time Frame: 0 - 200 mins
Measured by VAS questionnaire at 12 time points, used to calculate area under curve (AUC)
0 - 200 mins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

Saskatchewan Pulse Growers
Alberta Pulse Growers

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)

January 14, 2018

Study Completion (Actual)

January 14, 2018

Study Registration Dates

First Submitted

December 17, 2014

First Submitted That Met QC Criteria

March 5, 2015

First Posted (Estimate)

March 11, 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

  • B2014:114-5

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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