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
NCT number | NCT02370927 |
Other study ID # | B2014:114-4 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | December 2017 |
Verified date | July 2018 |
Source | University of Manitoba |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Richardson Centre for Functional Foods and Nutraceuticals | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba | Alberta Pulse Growers, Saskatchewan Pulse Growers |
Canada,
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 |
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