An interventional study of Test of effort on cycle on concentric or excentric mode and Kinetics on concentric or excentric mode during test of effort in Overweight, Healthy and Men, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-08.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Prevention
Main objective of this clinical trial is to compare the oxidation rates of main carbohydrate and lipid substrates during exercises carried out in eccentric dynamic pedaling mode on a cycloergometer compared to concentric exercises (classic pedaling) at the same oxygen consumption (VO2).
The hypothesis is that lipid oxidation during an eccentric exercise is higher than lipid oxidation during a concentric exercise, done in humans at the capacity of 30% of VO2max.
The written agreement of the subjects will be obtained after information on the aims, nature and possible risks of the study.
Before inclusion, the volunteers will be subjected to a medical check-up at the Nutritional Exploration Unit which includes an examination of personal and family history and current drug treatments, as well as a standard medical examination and a blood test for a biological check-up. Also, the volunteers will be subjected to a check-up with dietetics. Compliance with the inclusion/ exclusion criteria will be verified during this review. Volunteers included in the protocol will go to the Sports Medicine service, or the Nutritional Exploration Unit, or the Clinical Pharmacology Center (CPC) to perform the 11 interventions.
The study will be conducted in 6 periods:
T0 : A standard maximal exercices test performed on an cycloergometer to determine the subject's abilities (VO2) and to set the target powers of the experimental clinical tests. This test will take place in the Sports Medicine service.
T1 : A period of habituation to eccentric exercise, starting from 6 sessions of habituation realized over a period of 15 days where the sessions are gradually increased in duration and intensity. This test will take place in the Sports Medicine service. Before each session of habituation, a Visual Analogue Scale (VAS) will be performed. If the result will be greater than or equal to 3, the session will be rescheduled for another session after 48 hours.
T2 \& 3 : Two tests of effort, sub-maximal, progressive, carried out in eccentric mode and concentric mode (each spaced at least 48 hours) to determine the carbohydrate and lipid oxidation rates. Both tests will take place in the Sports Medicine service. The day before each visit, the evening meal will be standardized and eaten before 8 pm. Moreover, the day of both visits, the breakfast will be standardized and eaten 2 hours before the subject will go to Nutritional Exploration Unit.
T4 \& 5 : Two exercises tests during 30min performed at 30% VO2max and followed by indirect oxygen calorimetry (with canopy) extended over a period of 6 hours to measure the energy expenditure, the nature of the oxidized substrates (carbohydrates and lipids) and oxidation rates. The day before each visit, the evening meal will be standardized and eaten before 8 pm. Moreover, the day of both visits, the breakfast will be standardized and eaten 2 hours before the subject will go to Nutritional Exploration Unit. In addition, for each kinetic, 7 blood samples will be collected at several times. On these samples, insulin and blood sugar will be measured.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's planned enrollment of 12 is below the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
The exercise will start at 10% of VO2max. However, every six minutes, the level of VO2max will be increased by 10%, up to 50%.
Other: Test of effort on cycle on concentric or excentric mode · Other: Kinetics on concentric or excentric mode during test of effort
The exercise will start at 10% of VO2max. However, every six minutes, the level of VO2max will be increased by 10%, up to 50%.
Other: Test of effort on cycle on concentric or excentric mode · Other: Kinetics on concentric or excentric mode during test of effort
The subjects will have to carry out a test of effort in eccentric or concentric mode during 30 minutes performed at 30% of VO2max. The exercise will be followed by indirect oxygen calorimetry (with canopy) extended over a period of 6 hours to measure the energy expenditure, the nature of the oxidized substrates (carbohydrates and lipids) and oxidation rates. During each kinetic, 6 other blood samples will be collected at several times. On these samples, insulin and blood sugar will be measured.
Other: Test of effort on cycle on concentric or excentric mode · Other: Kinetics on concentric or excentric mode during test of effort
The subjects will have to carry out a test of effort in eccentric or concentric mode during 30 minutes performed at 30% of VO2max. The exercise will be followed by indirect oxygen calorimetry (with canopy) extended over a period of 6 hours to measure the energy expenditure, the nature of the oxidized substrates (carbohydrates and lipids) and oxidation rates. During each kinetic, 6 other blood samples will be collected at several times. On these samples, insulin and blood sugar will be measured.
Other: Test of effort on cycle on concentric or excentric mode · Other: Kinetics on concentric or excentric mode during test of effort
participants may receive 4 interventions sequentially during the protocol
participants may receive 4 interventions sequentially during the protocol
Measures of oxidation rate of lipid substrates at T2 visit and T3 visit
The oxidation rate of lipid substrates is measured at 10% of VO2max, 20% of VO2max, 40% of VO2max and 50% of VO2max
Time frame: Through effort test
Measures of oxidation rate of carbohydrates at T2 visit and T3 visit
The oxidation rate of carbohydrates is measured at10% of VO2max, 20% of VO2max, 40% of VO2max and 50% of VO2max
Time frame: Through effort test
Measure of total energy expenditure at T2 visit and T3 visit
At the T2 visit and T3 visit, the total energy expenditure is measured
Time frame: Trough exercise
Measure of total energy expenditure at T2 visit and T3 visit
At the T2 visit and T3 visit, the total energy expenditure is measured
Time frame: immediatly after exercise
Measure of total energy expenditure at T2 visit and T3 visit
At the T2 visit and T3 visit, the total energy expenditure is measured
Time frame: through recovery after exercise, an average of 1 hour
Measure of total energy expenditure
the total energy expenditure is measured during constant-power cycle ergometer tests. This secondary outcome measure will be measured during eccentric and concentric exercises.
Time frame: 30 min
Measure of energy expenditure during 6 hours of recovery after exercises
the energy expenditure is measured during constant-power cycle ergometer tests. This secondary outcome measure will be measured during both kinetics
Time frame: 6 hours
Measures of substrates oxidation rates at T4 visit and T5 visit
The oxidation rates of substrates are measured during exercises performed at 30% of VO2max
Time frame: through effort test
Measures of quantities of oxidized substrates at T4 visit and T5 visit
The quantities of oxidized substrates (carbohydrates, fats, proteins) are measured during exercises
Time frame: through effort test
Measures of quantities of carbohydrates at T4 visit and T5 visit
The quantities of oxidized carbohydrates are measured during the measure of energy expenditure
Time frame: Through energy expenditure measurment an average of 6 hours
Measures of quantities of fats at T4 visit and T5 visit
The quantities of fats are measured during the measure of energy expenditure
Time frame: Through energy expenditure measurment an average of 6 hours
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University Hospital, Clermont-Ferrand