Specificities of the Eccentric Exercise: Energy Expenditure and Nature of Oxidized Substrates (Speed-Enso)

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Overweight; Men
• Intervention / Treatment: Other: Test of effort on cycle on concentric or excentric mode; Other: Kinetics on concentric or excentric mode during test of effort

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • Recruiting
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2021
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Energy expenditure; eccentric training; concentric training; oxidized substrates
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: RBHP 2018 RICHARD; 2019-A00082-55 (Other Identifier: 2019-A00082-55)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No