PERFECT Project - Part 2 - Study 1

Obesity 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 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02402517
• Other study ID #: B2014:114-2
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: December 2017

Study information

• Verified date: May 2017
• 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) aerobic endurance and substrate oxidation during exercise 2) response of blood glucose, insulin and appetite on an aerobic exercise session, and 3) food intake two hours following the exercise session. The investigators hypothesize that consumption of food products 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 extruded pulse snacks 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)

• 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
• Obesity

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 14 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. (Composite measure)	0 - 240 min
Primary	Food Intake	Ad-libitum meal. Food consumed measured by weight.	at 120 min
Primary	Subjective Appetite	Measured by VAS questionnaire at 14 time points, used to calculate area under curve (AUC).( Composite measure)	0-240 min
Primary	Exercise intensity	Sixty minute exercise protocol at minutes 60 to 120. Oxygen consumption measured during exercise at 3 time points.	60 minutes
Secondary	Lactate concentration	60 minute exercise protocol at minutes 60 to 120. Measured before, during, and exercise exercise at 3 time points	60 minutes
Secondary	Palatability of treatments	Measured by VAS questionnaire	at 5 minutes
Secondary	Palatability of meal	Measured by VAS questionnaire	at 260 minutes
Secondary	Physical comfort	Measured by VAS questionnaire at 13 time points, used to calculate area under curve (AUC) (Composite measure)	0-240 min
Secondary	Energy/fatigue	Measured by VAS questionnaire at 13 time points, used to calculate area under curve (AUC) (Composite measure)	0-240 min
Secondary	Heart rate	Heart rate monitored over a 60 minute exercise protocol. To monitor exercise intensity and give a measure of fatigue (cardiovascular drift)	60-120 min
Secondary	Substrate Oxidation	Measured during 60 minute exercise protocol at minutes 60-120. Respiratory quotient measured during exercise at 3 time points.	60 minutes