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

U

University Hospital, Clermont-Ferrand

Status

Unknown

Conditions

Healthy
Overweight
Men

Treatments

Other: Test of effort on cycle on concentric or excentric mode
Other: Kinetics on concentric or excentric mode during test of effort

Study type

Interventional

Funder types

Other

Identifiers

NCT05319704
2019-A00082-55 (Other Identifier)
RBHP 2018 RICHARD

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 estimated patients

Sex

Male

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

12 participants in 4 patient groups, including a placebo group

Test of effort, sub-maximal, progressive, carried out in eccentric mode
Active Comparator group
Description:
The exercise will start at 10% of VO2max. However, every six minutes, the level of VO2max will be increased by 10%, up to 50%.
Treatment:
Other: Kinetics on concentric or excentric mode during test of effort
Other: Test of effort on cycle on concentric or excentric mode
Test of effort, sub-maximal, progressive, carried out in concentric mode
Placebo Comparator group
Description:
The exercise will start at 10% of VO2max. However, every six minutes, the level of VO2max will be increased by 10%, up to 50%.
Treatment:
Other: Kinetics on concentric or excentric mode during test of effort
Other: Test of effort on cycle on concentric or excentric mode
Kinetic in eccentric mode
Active Comparator group
Description:
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.
Treatment:
Other: Kinetics on concentric or excentric mode during test of effort
Other: Test of effort on cycle on concentric or excentric mode
Kinetic in concentric mode
Placebo Comparator group
Description:
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.
Treatment:
Other: Kinetics on concentric or excentric mode during test of effort
Other: Test of effort on cycle on concentric or excentric mode

Trial contacts and locations

1

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Central trial contact

Lise Laclautre

Data sourced from clinicaltrials.gov

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