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

Healthy Clinical Trial

— Speed-Enso  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05319704
• Other study ID #: RBHP 2018 RICHARD
• Secondary ID: 2019-A00082-55
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2021
• Est. completion date: August 2023

Study information

• Verified date: June 2021
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 334.73.754.963
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy
• Men
• Overweight

Intervention

Other:
• Test of effort on cycle on concentric or excentric mode
participants may receive 4 interventions sequentially during the protocol
• Kinetics on concentric or excentric mode during test of effort
participants may receive 4 interventions sequentially during the protocol

Locations

Country	Name	City	State
France	CHU clermont-ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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