PERFECT Project - Part 2 - Study 3

Obesity Prevention Clinical Trial

Official title:

Pulse EnRiched Food and Exercise Clinical Trials (PERFECT Project): Part 2 - Acute Effects of Pulse Ingredients in Food Products on Aerobic Endurance and Substrate Oxidation During Exercise, as Well as, the Blood Glucose, Insulin, Lactate and Food Intake Response Following an Endurance Exercise Session in Adults - Study 3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02365363
• Other study ID #: B2014:114-6
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: December 19, 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 bagels containing pulse ingredients on: 1) aerobic endurance and substrate oxidation during exercise 2) response of blood glucose, insulin and appetite to an aerobic exercise session, and 3) food intake two hours following the exercise session. We hypothesize that consumption of bagels containing pulse ingredients 60 minutes before exercise will increase aerobic endurance (lower oxygen consumption), decrease carbohydrate oxidation (greater respiratory quotient), and a reduction in lactate production during compared to the same exercise session following the ingestion of a non-pulse food. We also hypothesize that consumption of bagels containing pulse ingredients will lead to lower blood glucose, insulin, appetite and food intake, suggesting lower calorie compensation, following a 60-minute aerobic exercise session compared to the same exercise session following the ingestion of a non-pulse food.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 19, 2017
• Est. primary completion date: December 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

• 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 flour and pea fibre
Pulse ingredient bagel
• Pea flour and pea protein
Pulse ingredient bagel
• Pea flour + 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. Glucose will be determined by automated methods using Abbot Spectrum CCX Analyzer, and Insulin will be measured by commercially available RIA kits	0-240
Primary	Food Intake	Ad-libitum meal	120 min
Primary	Subjective Appetite	Motivation-to-eat VAS questionnaire	0-240 min
Primary	Exercise intensity	Oxygen consumption measured during exercise at 3 time points	60-120 min
Secondary	Palatability	Measured by VAS questionnaire	5 and 260 min
Secondary	Physical comfort	Measured by VAS questionnaire	0-240 min
Secondary	Energy/fatigue	Measured by VAS questionnaire	0 - 240 min
Secondary	Heart rate	To monitor exercise intensity and give a measure of fatigue (cardiovascular drift)	60-120 min
Secondary	Lactate concentration	Measured before, during, and exercise exercise at 3 time points	60-120 min
Secondary	Substrate Oxidation	Respiratory quotient measured during exercise at 3 time points	60-120 min