PERFECT Project - Part 1 - Study 2

Not Applicable

Completed

• Conditions: Obesity Prevention; Diabetes Prevention
• Interventions: Other: Pea protein; Other: Pea protein + pea starch; Other: Pea fibre + pea starch + pea protein; Other: Control; Other: Pea starch; Other: Pea fibre + pea starch

• Registration Number: NCT02366572
• Lead Sponsor: University of Manitoba

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2014-12-17
• Study First Submitted QC: 2015-02-18
• Study First Posted: 2015-02-19
• Study Start: 2016-03
• Primary Completion: 2017-03
• Study Completion: 2017-12
• Status Verified: 2021-04
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cereal with pea protein	Pea protein	Pea protein
Cereal w/ pea protein + pea starch: 10g	Pea protein + pea starch	Pea protein + pea starch: 10g
Cereal w/ pea protein + pea fibre + pea starch: 20g	Pea fibre + pea starch + pea protein	Pea protein + pea fibre + pea starch: 20g
Cereal control	Control	100% Wheat Flour
Cereal with pea starch	Pea starch	Pea starch
Cereal w/ pea starch + pea fibre: 5g	Pea fibre + pea starch	Pea starch + pea fibre: 5g

Primary Outcome Measures

Name	Time	Method
Food Intake	at 120 min	Measured by VAS questionnaire
Plasma Glucose and Insulin Concentrations	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
Subjective Appetite	0-200 min	Motivation-to-eat VAS questionnaire

Secondary Outcome Measures

Name	Time	Method
Physical comfort	0 - 200 min	Measured by VAS questionnaire
Energy/fatigue	0-200 min	Measured by VAS questionnaire
Palatability of treaments and meal	5 and 140 minutes	Measured by VAS questionnaire