PERFECT Project - Part 1 - Study 3

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 3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02385890
• Other study ID #: B2014:114-5
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: January 14, 2018

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 14, 2018
• Est. primary completion date: January 14, 2018
• 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 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

Related Conditions & MeSH terms

• Diabetes Prevention
• Obesity Prevention

Intervention

Other:
• Control
Non pulse ingredient bagel
• Pea flour
Pulse ingredient bagel
• Pea fibre
Pulse ingredient bagel
• Pea protein
Pulse ingredient bagel
• Pea flour + pea protein
Pulse ingredient bagel
• Pea fibre + pea protein
Pulse ingredient bagel

Locations

Country	Name	City	State
Canada	Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba	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 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	0-200
Primary	Food Intake	Ad-libitum meal. Food consumed measured by weight	at 120 min
Primary	Subjective Appetite	Motivation-to-eat VAS questionnaire used to calculate area under curve (AUC)	0-200 min
Secondary	Palatability of meal	Measured by VAS questionnaire	at 140 mins
Secondary	Palatability of treatments	Measured by VAS questionnaire	at 5 mins
Secondary	Physical comfort	Measured by VAS questionnaire at 12 time points used to calculate area under curve (AUC)	0 - 200 min
Secondary	Energy/fatigue measured by VAS questionnaire	Measured by VAS questionnaire at 12 time points, used to calculate area under curve (AUC)	0 - 200 mins