PERFECT Project - Part 1 - Study 3

Not Applicable

Completed

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

• Registration Number: NCT02385890
• Lead Sponsor: University of Manitoba

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2014-12-17
• Study First Submitted QC: 2015-03-05
• Study First Posted: 2015-03-11
• Study Start: 2016-10
• Primary Completion: 2018-01-14
• Study Completion: 2018-01-14
• Status Verified: 2021-04
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bagel with pea fibre	Pea fibre	Pea fibre
Bagel with pea flour	Pea flour	Pea flour
Bagel with pea protein	Pea protein	Pea protein
Bagel with pea flour + pea protein	Pea flour + pea protein	Pea flour + pea protein
Bagel with pea fibre + pea protein	Pea fibre + pea protein	Pea fibre + pea protein
Bagel control	Control	100% wheat flour

Primary Outcome Measures

Name	Time	Method
Plasma Glucose and Insulin Concentrations	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
Food Intake	at 120 min	Ad-libitum meal. Food consumed measured by weight
Subjective Appetite	0-200 min	Motivation-to-eat VAS questionnaire used to calculate area under curve (AUC)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada