PERFECT Project - Part 1 - Study 2

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 2

The objectives are to test the acute effects of different cereals 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.

We hypothesize that cereals containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake responses compared to non-pulse cereals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

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
  • Competitive sports or athletic training at a high intensity
  • 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
Placebo Comparator: Cereal control
100% Wheat Flour
Other: Control
Non pulse extruded cereal
Experimental: Cereal with pea protein
Pea protein
Other: Pea protein
Pulse extruded cereal
Experimental: Cereal with pea starch
Pea starch
Other: Pea starch
Pulse extruded cereal
Experimental: Cereal w/ pea starch + pea fibre: 5g
Pea starch + pea fibre: 5g
Other: Pea fibre + pea starch
Pulse extruded cereal
Experimental: Cereal w/ pea protein + pea starch: 10g
Pea protein + pea starch: 10g
Other: Pea protein + pea starch
Pulse extruded cereal
Experimental: Cereal w/ pea protein + pea fibre + pea starch: 20g
Pea protein + pea fibre + pea starch: 20g
Other: Pea fibre + pea starch + pea protein
Pulse extruded cereal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Glucose and Insulin Concentrations
Time Frame: 0 - 200 min
Glucose will be determined by automated methods using Abbot Spectrum CCX Analyzer, and Insulin will be measured by commercially available RIA kits
0 - 200 min
Food Intake
Time Frame: at 120 min
Measured by VAS questionnaire
at 120 min
Subjective Appetite
Time Frame: 0-200 min
Motivation-to-eat VAS questionnaire
0-200 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Palatability of treaments and meal
Time Frame: 5 and 140 minutes
Measured by VAS questionnaire
5 and 140 minutes
Physical comfort
Time Frame: 0 - 200 min
Measured by VAS questionnaire
0 - 200 min
Energy/fatigue
Time Frame: 0-200 min
Measured by VAS questionnaire
0-200 min

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 17, 2014

First Submitted That Met QC Criteria

February 18, 2015

First Posted (Estimate)

February 19, 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

  • B2014:114-3

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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