Extreme Exercise and Energy Expenditure (4E) Study

NCT05895916 | Completed

• 1 other identifier: 4E study
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Diseases; Obesity, Visceral; Liver Fat; Metabolic Syndrome; Lifestyle

Keywords

cardiac fat; cardiometabolic health; cardiorespiratory fitness; ectopic fat; energy balance; exercise; liver fat; obesity; physical activity; visceral adipose tissue

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (14)

• Changes from baseline in fasting total cholesterol following the extreme exercise prescription

  Before and the day (or next day) following the extreme exercise prescription

• Changes from baseline in fasting LDL cholesterol following the extreme exercise prescription

  Before and the day (or next day) following the extreme exercise prescription

• Changes from baseline in fasting HDL cholesterol following the extreme exercise prescription

  Before and the day (or next day) following the extreme exercise prescription

• Changes from baseline in fasting plasma triglycerides following the extreme exercise prescription

  Before and the day (or next day) following the extreme exercise prescription

• Changes from baseline in fasting glycated hemoglobin following the extreme exercise prescription

  Before and the day (or next day) following the extreme exercise prescription

Study Arms (1)

Extreme exercise group

EXPERIMENTAL

1,144 km of road cycling on seven consecutive days

Behavioral: High-volume road cycling

Interventions

High-volume road cycling BEHAVIORAL

1,144 km of road cycling performed on seven consecutive days with an increase in energy intake to maintain a stable body weight

Extreme exercise group

Eligibility Criteria

• Age: 50 Years - 66 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut universitaire de cardiologie et de pneumologie de Québec, University Laval: lead

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Québec, G1V 4G5, Canada

Location

Related Publications (20)

• 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.

  PMID: 25918126 BACKGROUND

• 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.

  PMID: 24415616 BACKGROUND

• 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.

  PMID: 25904145 BACKGROUND

• 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.

  PMID: 24415617 BACKGROUND

• 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.

  PMID: 26062953 BACKGROUND

• 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.

  PMID: 2196040 BACKGROUND

• 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.

  PMID: 18356555 BACKGROUND

• 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.

  PMID: 22949540 BACKGROUND

• 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.

  PMID: 22262155 BACKGROUND

• 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.

  PMID: 10896648 BACKGROUND

• 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.

  PMID: 25661557 BACKGROUND

• 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.

  PMID: 11832527 BACKGROUND

• 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.

  PMID: 11333990 BACKGROUND

• 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.

  PMID: 26561630 BACKGROUND

• 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.

  PMID: 26490491 BACKGROUND

• 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.

  PMID: 14602744 BACKGROUND

• 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.

  PMID: 16091479 BACKGROUND

• 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.

  PMID: 18212276 BACKGROUND

• 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.

  PMID: 24589564 BACKGROUND

• 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.

  PMID: 1761005 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Obesity, Abdominal; Fatty Liver; Metabolic Syndrome; Motor Activity; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Behavior

Study Officials

• Natalie Alméras, Ph.D.

  Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 9, 2023
• Study Start: June 7, 2018
• Primary Completion: August 13, 2019
• Study Completion: August 13, 2019
• Last Updated: June 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)