PERFECT Project - Part 1 - Study 1

Not Applicable

Completed

• Conditions: Obesity Prevention; Diabetes Prevention

• Registration Number: NCT02402504
• Lead Sponsor: University of Manitoba

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-20
• Study Start: 2015-03
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-30
• Primary Completion: 2016-07
• 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: 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

Exclusion Criteria

• Restrained eaters
• Regularly skip breakfast
• Smokers
• Those on medications that may influence study outcomes or have experienced any gastrointestinal related health conditions/surgeries over the past year
• Competitive sports or athletic training at a high intensity
• Those unable to walk for an hour continuously

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Subjective Appetite	0-200 min	Measured by VAS questionnaire at 12 time points used to calculate area under curve (AUC) (Composite measure)
Plasma Glucose and Insulin Concentrations	0 - 200 min	Measured in blood using intravenous catheter at 12 time points and 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 (Composite measure)
Food Intake	at 120 min	Ad-libitum meal

Secondary Outcome Measures

Name	Time	Method
Physical Comfort	0-200 min	Measured by VAS questionnaire at 12 time points used to calculate area under curve (AUC). (Composite measure)
Palatability of meal	at 140 minutes	Measured by VAS questionnaire
Palatability of treatments	at 5 minutes	Measured by VAS questionnaire
Energy and Fatigue	0-200 min	Measured by VAS questionnaire at 12 time points and use to calculate AUC. (Composite measure)

Trial Locations

Locations (1)

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