Specificities of the Eccentric Exercise: Energy Expenditure and Nature of Oxidized Substrates

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Specificities of the Eccentric Exercise: Energy Expenditure and Nature of Oxidized Substrates

Conditions
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Overweight, Healthy, Men

Intervention / Treatment
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* Other: Test of effort on cycle on concentric or excentric mode
* Other: Kinetics on concentric or excentric mode during test of effort


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male volunteers between 20 and 40 years old (20 ≥ years ≤ 40) Subjects considered healthy by investigator based on the examination, medical and clinical examination Body Mass Index between 27 and 35 kg/m² (27 < BMI < 35) Biological check up considered compatible with study participation Physical check up considered compatible with study participation (no bones, articular or muscular problems) Person who don't smoke and has no treatment Person who is in the position to sign informed consent Exclusion Criteria: Smoking Person who take any kind of treatments except Paracétamol All conditions who have interaction with this clinical trial, or who can deteriorate the exercise capacity or the realization of canopy (claustrophobia) Criteria Administrative and legal factors Person who isn't consent Subject not affiliated with social security Subject during the exclusion period of a previous study (after verification in the Biomedical Research Volunteers File).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: participants may receive 4 differents interventions sequentially during the protocol
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test of effort, sub-maximal, progressive, carried out in eccentric mode<br>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<br>* participants may receive 4 interventions sequentially during the protocol<br>Other: Kinetics on concentric or excentric mode during test of effort<br>* participants may receive 4 interventions sequentially during the protocol<br>|
| Placebo Comparator: Test of effort, sub-maximal, progressive, carried out in concentric mode<br>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<br>* participants may receive 4 interventions sequentially during the protocol<br>Other: Kinetics on concentric or excentric mode during test of effort<br>* participants may receive 4 interventions sequentially during the protocol<br>|
| Active Comparator: Kinetic in eccentric mode<br>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<br>* participants may receive 4 interventions sequentially during the protocol<br>Other: Kinetics on concentric or excentric mode during test of effort<br>* participants may receive 4 interventions sequentially during the protocol<br>|
| Placebo Comparator: Kinetic in concentric mode<br>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<br>* participants may receive 4 interventions sequentially during the protocol<br>Other: Kinetics on concentric or excentric mode during test of effort<br>* participants may receive 4 interventions sequentially during the protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Through effort test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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. | 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 | 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 | 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 | 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 | 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 | Through energy expenditure measurment an average of 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Energy expenditure, eccentric training, concentric training, oxidized substrates