PERFECT Project - Part 2 - Study 2

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 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02370927
• Other study ID #: B2014:114-4
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: December 2017

Study information

• Verified date: July 2018
• 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) 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. The investigators hypothesize that consumption of cereals 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. The investigators also hypothesize that consumption of cereals 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 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 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)
• Body Mass Index 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
• Those who are active (organized activities or athletic training at a high intensity; = 150 minutes per week of moderate to vigorous physical activity)
• 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
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 Concentrations	Measured in blood using intravenous catheter. Glucose will be determined by automated methods using Abbot Spectrum Clinical Chemistry-X Analyzer,	0-240 minutes
Primary	Food Intake	Ad-libitum meal	at 240 minutes
Primary	Subjective Appetite	Motivation-to-eat Visual Analog Scale questionnaire	0-240 minutes
Primary	Exercise intensity	Oxygen consumption measured during exercise at 3 time points	60-120 minutes
Primary	Insulin concentrations	Measured in blood using intravenous catheter. and Insulin will be measured by commercially available radioimmunoassay (RIA) kits	0-240 minutes
Secondary	Palatability measured by Visual Analog Scale questionnaire	Food tasting	5 and 260 minutes
Secondary	Physical comfort measured by Visual Analog Scale questionnaire	Contributions from energy intake	0-240 minutes
Secondary	Energy/fatigue measured by Visual Analog Scale questionnaire	Estimate of energy expenditure	0 - 240 minutes
Secondary	Heart rate	To monitor exercise intensity and give a measure of fatigue (cardiovascular drift)	60-120 minutes
Secondary	Substrate Oxidation	Respiratory quotient measured during exercise at 3 time points	60-120 minutes
Secondary	Lactate concentration	Measured before, during, and after exercise exercise at 3 time points	60-120 minutes