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

NCT ID: NCT05319704

Last Updated: 2022-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-17

Study Completion Date

2023-08-31

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.

Conditions

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Overweight Healthy Men

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

participants may receive 4 differents interventions sequentially during the protocol
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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%.

Group Type ACTIVE_COMPARATOR

Test of effort on cycle on concentric or excentric mode

Intervention Type OTHER

participants may receive 4 interventions sequentially during the protocol

Kinetics on concentric or excentric mode during test of effort

Intervention Type OTHER

participants may receive 4 interventions sequentially during the protocol

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%.

Group Type PLACEBO_COMPARATOR

Test of effort on cycle on concentric or excentric mode

Intervention Type OTHER

participants may receive 4 interventions sequentially during the protocol

Kinetics on concentric or excentric mode during test of effort

Intervention Type OTHER

participants may receive 4 interventions sequentially during the protocol

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.

Group Type ACTIVE_COMPARATOR

Test of effort on cycle on concentric or excentric mode

Intervention Type OTHER

participants may receive 4 interventions sequentially during the protocol

Kinetics on concentric or excentric mode during test of effort

Intervention Type OTHER

participants may receive 4 interventions sequentially during the protocol

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.

Group Type PLACEBO_COMPARATOR

Test of effort on cycle on concentric or excentric mode

Intervention Type OTHER

participants may receive 4 interventions sequentially during the protocol

Kinetics on concentric or excentric mode during test of effort

Intervention Type OTHER

participants may receive 4 interventions sequentially during the protocol

Interventions

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Test of effort on cycle on concentric or excentric mode

participants may receive 4 interventions sequentially during the protocol

Intervention Type OTHER

Kinetics on concentric or excentric mode during test of effort

participants may receive 4 interventions sequentially during the protocol

Intervention Type OTHER

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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabrice RANNOU

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU clermont-ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Lise Laclautre

Role: CONTACT

334.73.754.963

Facility Contacts

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Lise Laclautre

Role: primary

Other Identifiers

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2019-A00082-55

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2018 RICHARD

Identifier Type: -

Identifier Source: org_study_id

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