Clinical trial NCT05319704: Specificities of the Eccentric Exercise: Energy Expenditure and Nature of Oxidized Substrates
Official title: Specificities of the Eccentric Exercise: Energy Expenditure and Nature of Oxidized Substrates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight
Healthy
Men
Keywords: Energy expenditure
eccentric training
concentric training
oxidized substrates
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: participants may receive 4 differents interventions sequentially during the protocol
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Measures of oxidation rate of lipid substrates at T2 visit and T3 visit
timeFrame: Through effort test
Secondary outcomes:
measure: Measures of oxidation rate of carbohydrates at T2 visit and T3 visit
timeFrame: Through effort test
measure: Measure of total energy expenditure at T2 visit and T3 visit
timeFrame: Trough exercise
measure: Measure of total energy expenditure at T2 visit and T3 visit
timeFrame: immediatly after exercise
measure: Measure of total energy expenditure at T2 visit and T3 visit
timeFrame: through recovery after exercise, an average of 1 hour
measure: Measure of total energy expenditure
timeFrame: 30 min
measure: Measure of energy expenditure during 6 hours of recovery after exercises
timeFrame: 6 hours
measure: Measures of substrates oxidation rates at T4 visit and T5 visit
timeFrame: through effort test
measure: Measures of quantities of oxidized substrates at T4 visit and T5 visit
timeFrame: through effort test
measure: Measures of quantities of carbohydrates at T4 visit and T5 visit
timeFrame: Through energy expenditure measurment an average of 6 hours
measure: Measures of quantities of fats at T4 visit and T5 visit
timeFrame: Through energy expenditure measurment an average of 6 hours
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Fabrice RANNOU
role: PRINCIPAL_INVESTIGATOR
References: