Cardiovascular Diseases Clinical Trial
Official title:
Extreme Exercise and Energy Expenditure (4E) Study
NCT number | NCT05895916 |
Other study ID # | 4E study |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 7, 2018 |
Est. completion date | August 13, 2019 |
The goal of this clinical trial is to provide evidence, through an extreme exercise prescription (1,144 km of road cycling on seven consecutive days), that weight loss is not the appropriate outcome to evaluate the effects of exercise on abdominal adiposity and ectopic fat depots (e.g. liver fat and epi/pericardial fat) in eleven recreational middle-aged male cyclists (aged 50 to 66 years) without symptoms of cardiovascular disease. The main questions it aims to answer are: - If energy intake is substantially increased to compensate energy expenditure and prevent weight loss following an extreme exercise prescription, will significant changes in body composition and body fat distribution be observed? - Will these changes translate into improvements in the cardiometabolic health profile even in the absence of weight loss? Participants will be asked to partake in several evaluations: fasting plasma lipoprotein-lipid profile and inflammation markers, glycated hemoglobin, cardiorespiratory fitness, submaximal exercise test including measurement of energy expenditure, resting and exercise blood pressure and heart rate, evaluation of regional adiposity, liver fat content, epi/pericardial fat, nutritional quality, and level of physical activity. After baseline evaluations, participants will be asked to alternately bike 208 km and 104 km per day on a pre-specified course for seven consecutive days. They will be accompanied during each of the seven bike rides by research professionals in a recreational vehicle. Participants' weight, body composition and waist circumference will be measured under standardized conditions in the morning after an overnight fast and after the exercise. Their heart rate will be continuously monitored, and participants will wear accelerometers to estimate their daily exercise-related energy expenditure. Foods and fluids will be provided to participants and recorded. At the end of the 1,144 km/ 7-days bike ride, baseline evaluations will be repeated with the exception of the maximal exercise treadmill test, nutritional quality, and level of physical activity. To facilitate the conduct of the protocol, the eleven participants will be evaluated and followed in two distinct groups.
Status | Completed |
Enrollment | 13 |
Est. completion date | August 13, 2019 |
Est. primary completion date | August 13, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 50 Years to 66 Years |
Eligibility | Inclusion Criteria: - Male - Between the ages of 50 and 66 years - Asymptomatic for cardiovascular disease - Reporting at least 5,000 km per year of road cycling at an average pace of about 30 km/h Exclusion Criteria: - Retired competitive athletes/competitive athletes - Undergoing hormonal or corticosteroid therapy - Presenting a cancer not in remission - Presenting an absolute contraindication to MRI - Presenting an absolute contraindication to maximal cardiopulmonary exercise testing |
Country | Name | City | State |
---|---|---|---|
Canada | Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval | Québec |
Lead Sponsor | Collaborator |
---|---|
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval |
Canada,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes from baseline in body weight assessed by direct segmental multi-frequency bioimpedance analysis following the extreme exercise prescription | Changes in body weight in kilograms | Before and the day (or next day) following the extreme exercise prescription | |
Primary | Changes from baseline in fat mass assessed by direct segmental multi-frequency bioimpedance analysis following the extreme exercise prescription | Changes in fat mass in kilograms | Before and the day (or next day) following the extreme exercise prescription | |
Primary | Changes from baseline in fat-free mass assessed by direct segmental multi-frequency bioimpedance analysis following the extreme exercise prescription | Changes in fat-free mass in kilograms | Before and the day (or next day) following the extreme exercise prescription | |
Primary | Changes from baseline in body water assessed by direct segmental multi-frequency bioimpedance analysis following the extreme exercise prescription | Changes in body water in kilograms | Before and the day (or next day) following the extreme exercise prescription | |
Primary | Changes from baseline in waist circumference assessed using a standardized measuring tape following the extreme exercise prescription | Changes in waist circumference in centimeters | Before and the day (or next day) following the extreme exercise prescription | |
Primary | Changes from baseline in visceral adipose tissue assessed using magnetic resonance imaging following the extreme exercise prescription | Changes in visceral adipose tissue in milliliters | Before and the day (or next day) following the extreme exercise prescription | |
Primary | Changes from baseline in subcutaneous adipose tissue assessed using magnetic resonance imaging following the extreme exercise prescription | Changes in subcutaneous adipose tissue in milliliters | Before and the day (or next day) following the extreme exercise prescription | |
Primary | Changes from baseline in epicardial adipose tissue assessed using magnetic resonance imaging following the extreme exercise prescription | Changes in epicardial adipose tissue in milliliters | Before and the day (or next day) following the extreme exercise prescription | |
Primary | Changes from baseline in pericardial adipose tissue assessed using magnetic resonance imaging following the extreme exercise prescription | Changes in pericardial adipose tissue in milliliters | Before and the day (or next day) following the extreme exercise prescription | |
Primary | Changes from baseline in liver fat content assessed using magnetic resonance imaging with spectroscopy following the extreme exercise prescription | Changes in liver fat content in percentage | Before and the day (or next day) following the extreme exercise prescription | |
Secondary | Changes from baseline in fasting total cholesterol following the extreme exercise prescription | Changes in fasting total cholesterol in millimoles per liter | Before and the day (or next day) following the extreme exercise prescription | |
Secondary | Changes from baseline in fasting LDL cholesterol following the extreme exercise prescription | Changes in fasting LDL cholesterol in millimoles per liter | Before and the day (or next day) following the extreme exercise prescription | |
Secondary | Changes from baseline in fasting HDL cholesterol following the extreme exercise prescription | Changes in fasting HDL cholesterol in millimoles per liter | Before and the day (or next day) following the extreme exercise prescription | |
Secondary | Changes from baseline in fasting plasma triglycerides following the extreme exercise prescription | Changes in fasting plasma triglycerides in millimoles per liter | Before and the day (or next day) following the extreme exercise prescription | |
Secondary | Changes from baseline in fasting glycated hemoglobin following the extreme exercise prescription | Changes in fasting glycated hemoglobin in percentage | Before and the day (or next day) following the extreme exercise prescription | |
Secondary | Changes from baseline in fasting apolipoprotein A1 following the extreme exercise prescription | Changes in fasting apolipoprotein A1 in grams per liter | Before and the day (or next day) following the extreme exercise prescription | |
Secondary | Changes from baseline in fasting apolipoprotein B following the extreme exercise prescription | Changes in fasting apolipoprotein B in grams per liter | Before and the day (or next day) following the extreme exercise prescription | |
Secondary | Changes from baseline in fasting adiponectin following the extreme exercise prescription | Changes in fasting adiponectin in micrograms per milliliter | Before and the day (or next day) following the extreme exercise prescription | |
Secondary | Changes from baseline in fasting leptin following the extreme exercise prescription | Changes in fasting leptin in nanograms per milliliter | Before and the day (or next day) following the extreme exercise prescription | |
Secondary | Changes from baseline in fasting C-reactive protein following the extreme exercise prescription | Changes in fasting C-reactive protein in milligrams per liter | Before and the day (or next day) following the extreme exercise prescription | |
Secondary | Changes from baseline in fasting interleukin-6 following the extreme exercise prescription | Changes in fasting interleukin-6 in picograms per milliliter | Before and the day (or next day) following the extreme exercise prescription | |
Secondary | Changes from baseline in fasting tumor necrosis factor alpha following the extreme exercise prescription | Changes in fasting tumor necrosis factor alpha in picograms per milliliter | Before and the day (or next day) following the extreme exercise prescription | |
Secondary | Changes from baseline in resting systolic blood pressure following the extreme exercise prescription | Changes in resting systolic blood pressure in millimeters of mercury | Before and the day (or next day) following the extreme exercise prescription | |
Secondary | Changes from baseline in resting diastolic blood pressure following the extreme exercise prescription | Changes in resting diastolic blood pressure in millimeters of mercury | Before and the day (or next day) following the extreme exercise prescription |
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