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,
Almeras N, Mimeault N, Serresse O, Boulay MR, Tremblay A. Non-exercise daily energy expenditure and physical activity pattern in male endurance athletes. Eur J Appl Physiol Occup Physiol. 1991;63(3-4):184-7. doi: 10.1007/BF00233845. — View Citation
Blair SN, Archer E, Hand GA. Commentary: Luke and Cooper are wrong: physical activity has a crucial role in weight management and determinants of obesity. Int J Epidemiol. 2013 Dec;42(6):1836-8. doi: 10.1093/ije/dyt160. No abstract available. — View Citation
Blair SN. Physical inactivity and obesity is not a myth: Dr. Steven Blair comments on Dr. Aseem Malhotra's editorial. Br J Sports Med. 2015 Aug;49(15):968-9. doi: 10.1136/bjsports-2015-094989. Epub 2015 Jun 10. No abstract available. — View Citation
Borel AL, Nazare JA, Smith J, Almeras N, Tremblay A, Bergeron J, Poirier P, Despres JP. Visceral and not subcutaneous abdominal adiposity reduction drives the benefits of a 1-year lifestyle modification program. Obesity (Silver Spring). 2012 Jun;20(6):1223-33. doi: 10.1038/oby.2011.396. Epub 2012 Jan 19. — View Citation
De Larochelliere E, Cote J, Gilbert G, Bibeau K, Ross MK, Dion-Roy V, Pibarot P, Despres JP, Larose E. Visceral/epicardial adiposity in nonobese and apparently healthy young adults: association with the cardiometabolic profile. Atherosclerosis. 2014 May;234(1):23-9. doi: 10.1016/j.atherosclerosis.2014.01.053. Epub 2014 Feb 7. — View Citation
Despres JP, Lemieux I, Bergeron J, Pibarot P, Mathieu P, Larose E, Rodes-Cabau J, Bertrand OF, Poirier P. Abdominal obesity and the metabolic syndrome: contribution to global cardiometabolic risk. Arterioscler Thromb Vasc Biol. 2008 Jun;28(6):1039-49. doi: 10.1161/ATVBAHA.107.159228. Epub 2008 Mar 20. Erratum In: Arterioscler Thromb Vasc Biol. 2008 Jul;28(7):e151. — View Citation
Despres JP, Moorjani S, Lupien PJ, Tremblay A, Nadeau A, Bouchard C. Regional distribution of body fat, plasma lipoproteins, and cardiovascular disease. Arteriosclerosis. 1990 Jul-Aug;10(4):497-511. doi: 10.1161/01.atv.10.4.497. — View Citation
Despres JP. Body fat distribution and risk of cardiovascular disease: an update. Circulation. 2012 Sep 4;126(10):1301-13. doi: 10.1161/CIRCULATIONAHA.111.067264. No abstract available. — View Citation
Despres JP. Exercise and energy balance: going to extremes to show that body weight is not the best outcome. Am J Clin Nutr. 2015 Dec;102(6):1303-4. doi: 10.3945/ajcn.115.124560. Epub 2015 Nov 11. No abstract available. — View Citation
Despres JP. Obesity and cardiovascular disease: weight loss is not the only target. Can J Cardiol. 2015 Feb;31(2):216-22. doi: 10.1016/j.cjca.2014.12.009. Epub 2014 Dec 11. — View Citation
Iacobellis G, Leonetti F. Epicardial adipose tissue and insulin resistance in obese subjects. J Clin Endocrinol Metab. 2005 Nov;90(11):6300-2. doi: 10.1210/jc.2005-1087. Epub 2005 Aug 9. — View Citation
Iacobellis G, Ribaudo MC, Assael F, Vecci E, Tiberti C, Zappaterreno A, Di Mario U, Leonetti F. Echocardiographic epicardial adipose tissue is related to anthropometric and clinical parameters of metabolic syndrome: a new indicator of cardiovascular risk. J Clin Endocrinol Metab. 2003 Nov;88(11):5163-8. doi: 10.1210/jc.2003-030698. — View Citation
Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512. — View Citation
Kraus WE, Bittner V, Appel L, Blair SN, Church T, Despres JP, Franklin BA, Miller TD, Pate RR, Taylor-Piliae RE, Vafiadis DK, Whitsel L; American Heart Association Physical Activity Committee of the Council on Lifestyle and Metabolic Health, Council on Clinical Cardiology, Council on Hypertension, and Council on Cardiovascular and Stroke Nursing. The National Physical Activity Plan: a call to action from the American Heart Association: a science advisory from the American Heart Association. Circulation. 2015 May 26;131(21):1932-40. doi: 10.1161/CIR.0000000000000203. Epub 2015 Apr 27. No abstract available. — View Citation
Luke A, Cooper RS. Physical activity does not influence obesity risk: time to clarify the public health message. Int J Epidemiol. 2013 Dec;42(6):1831-6. doi: 10.1093/ije/dyt159. No abstract available. — View Citation
Malhotra A, Noakes T, Phinney S. It is time to bust the myth of physical inactivity and obesity: you cannot outrun a bad diet. Br J Sports Med. 2015 Aug;49(15):967-8. doi: 10.1136/bjsports-2015-094911. Epub 2015 Apr 22. No abstract available. — View Citation
Rosenkilde M, Morville T, Andersen PR, Kjaer K, Rasmusen H, Holst JJ, Dela F, Westerterp K, Sjodin A, Helge JW. Inability to match energy intake with energy expenditure at sustained near-maximal rates of energy expenditure in older men during a 14-d cycling expedition. Am J Clin Nutr. 2015 Dec;102(6):1398-405. doi: 10.3945/ajcn.115.109918. Epub 2015 Oct 21. — View Citation
Rosito GA, Massaro JM, Hoffmann U, Ruberg FL, Mahabadi AA, Vasan RS, O'Donnell CJ, Fox CS. Pericardial fat, visceral abdominal fat, cardiovascular disease risk factors, and vascular calcification in a community-based sample: the Framingham Heart Study. Circulation. 2008 Feb 5;117(5):605-13. doi: 10.1161/CIRCULATIONAHA.107.743062. Epub 2008 Jan 22. — View Citation
Ross R, Dagnone D, Jones PJ, Smith H, Paddags A, Hudson R, Janssen I. Reduction in obesity and related comorbid conditions after diet-induced weight loss or exercise-induced weight loss in men. A randomized, controlled trial. Ann Intern Med. 2000 Jul 18;133(2):92-103. doi: 10.7326/0003-4819-133-2-200007180-00008. — View Citation
Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801. — View Citation
* 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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