PERFECT Project - Part 1 - Study 1

Obesity Prevention Clinical Trial

Official title:

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 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02402504
• Other study ID #: B2014:114-1
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: December 2017

Study information

• Verified date: April 2021
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Prevention
• Obesity Prevention

Intervention

Other:
• Control
Non pulse extruded snack
• Small particle size pea flour
Pulse extruded snack
• Large particle size pea flour
Pulse extruded snack
• Lentil flour
Pulse extruded snack
• Navy bean flour
Pulse extruded snack
• Pinto bean flour
Pulse extruded snack

Locations

Country	Name	City	State
Canada	Richardson Centre for Functional Foods and Nutraceuticals	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
University of Manitoba	Alberta Pulse Growers, Saskatchewan Pulse Growers

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Glucose and Insulin Concentrations	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)	0 - 200 min
Primary	Food Intake	Ad-libitum meal	at 120 min
Primary	Subjective Appetite	Measured by VAS questionnaire at 12 time points used to calculate area under curve (AUC) (Composite measure)	0-200 min
Secondary	Palatability of treatments	Measured by VAS questionnaire	at 5 minutes
Secondary	Palatability of meal	Measured by VAS questionnaire	at 140 minutes
Secondary	Energy and Fatigue	Measured by VAS questionnaire at 12 time points and use to calculate AUC. (Composite measure)	0-200 min
Secondary	Physical Comfort	Measured by VAS questionnaire at 12 time points used to calculate area under curve (AUC). (Composite measure)	0-200 min