PERFECT Project - Part 1 - Study 2

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 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02366572
• Other study ID #: B2014:114-3
• Status: Completed
• Phase: N/A
• Start date: March 2016
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2017
• Est. primary completion date: March 2017
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Prevention
• Obesity Prevention

Intervention

Other:
• Control
Non pulse extruded cereal
• Pea protein
Pulse extruded cereal
• Pea starch
Pulse extruded cereal
• Pea fibre + pea starch
Pulse extruded cereal
• Pea protein + pea starch
Pulse extruded cereal
• Pea fibre + pea starch + pea protein
Pulse extruded cereal

Locations

Country	Name	City	State
n/a

Sponsors (3)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Glucose and Insulin Concentrations	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
Primary	Food Intake	Measured by VAS questionnaire	at 120 min
Primary	Subjective Appetite	Motivation-to-eat VAS questionnaire	0-200 min
Secondary	Palatability of treaments and meal	Measured by VAS questionnaire	5 and 140 minutes
Secondary	Physical comfort	Measured by VAS questionnaire	0 - 200 min
Secondary	Energy/fatigue	Measured by VAS questionnaire	0-200 min