OverweightSpeed-EnsoNCT05319704
Specificities of the Eccentric Exercise: Energy Expenditure and Nature of Oxidized Substrates
A study testing Test of effort on cycle on concentric or excentric mode and Kinetics on concentric or excentric mode during test of effort in people with Overweight and Healthy, run by University Hospital, Clermont-Ferrand at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Healthy, Men
- What is being tested?
- Test of effort on cycle on concentric or excentric mode and Kinetics on concentric or excentric mode during test of effort
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2021to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU clermont-ferrand
Clermont-Ferrand
Lise Laclautre
Fabrice RANNOU
About this study
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.
Read the 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.
- Conditions
- Overweight, Healthy, Men
- Being tested
- Test of effort on cycle on concentric or excentric mode, Kinetics on concentric or excentric mode during test of effort
- Keywords
- Energy expenditure, eccentric training, concentric training, oxidized substrates
- Medical subject headings
- Overweight, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test of effort on cycle on concentric or excentric modeOther
participants may receive 4 interventions sequentially during the protocol
Kinetics on concentric or excentric mode during test of effortOther
participants may receive 4 interventions sequentially during the protocol
| Study group | Role | What they receive |
|---|---|---|
| Test of effort, sub-maximal, progressive, carried out in eccentric mode | Active comparator | The exercise will start at 10% of VO2max. However, every six minutes, the level of VO2max will be increased by 10%, up to 50%. Receives: Other: Test of effort on cycle on concentric or excentric mode; Other: Kinetics on concentric or excentric mode during test of effort |
| Test of effort, sub-maximal, progressive, carried out in concentric mode | Placebo comparator | The exercise will start at 10% of VO2max. However, every six minutes, the level of VO2max will be increased by 10%, up to 50%. Receives: Other: Test of effort on cycle on concentric or excentric mode; Other: Kinetics on concentric or excentric mode during test of effort |
| Kinetic in eccentric mode | Active comparator | 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. Receives: Other: Test of effort on cycle on concentric or excentric mode; Other: Kinetics on concentric or excentric mode during test of effort |
| Kinetic in concentric mode | Placebo comparator | 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. Receives: Other: Test of effort on cycle on concentric or excentric mode; Other: Kinetics on concentric or excentric mode during test of effort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through effort test
Secondary outcomes (10)
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
Measured: 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
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
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
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Through energy expenditure measurment an average of 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start17 Feb 2021
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- participants may receive 4 differents interventions sequentially during the protocol
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice RANNOU, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319704
- Sponsor's protocol ID
- RBHP 2018 RICHARD
- Other IDs
- 2019-A00082-55
- Acronym
- Speed-Enso
- Status last verified
- Jun 2021
- First submitted
- 30 Jun 2021
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specificities of the Eccentric Exercise: Energy Expenditure and Nature of Oxidized Substrates
- ClinicalTrials.gov ID
- NCT05319704
- Acronym / sponsor ID
- Speed-Enso / RBHP 2018 RICHARD
- Conditions
- Overweight, Healthy, Men
- Keywords
- Energy expenditure, eccentric training, concentric training, oxidized substrates
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- participants may receive 4 differents interventions sequentially during the protocol
| Arm | Type | Receives |
|---|---|---|
| Test of effort, sub-maximal, progressive, carried out in eccentric mode | Active comparator | Other: Test of effort on cycle on concentric or excentric mode, Other: Kinetics on concentric or excentric mode during test of effortThe exercise will start at 10% of VO2max. However, every six minutes, the level of VO2max will be increased by 10%, up to 50%. |
| Test of effort, sub-maximal, progressive, carried out in concentric mode | Placebo comparator | Other: Test of effort on cycle on concentric or excentric mode, Other: Kinetics on concentric or excentric mode during test of effortThe exercise will start at 10% of VO2max. However, every six minutes, the level of VO2max will be increased by 10%, up to 50%. |
| Kinetic in eccentric mode | Active comparator | Other: Test of effort on cycle on concentric or excentric mode, Other: Kinetics on concentric or excentric mode during test of effortThe 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. |
| Kinetic in concentric mode | Placebo comparator | Other: Test of effort on cycle on concentric or excentric mode, Other: Kinetics on concentric or excentric mode during test of effortThe 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test of effort on cycle on concentric or excentric modeparticipants may receive 4 interventions sequentially during the protocol | Other | Kinetic in concentric mode, Kinetic in eccentric mode, Test of effort, sub-maximal, progressive, carried out in concentric mode, Test of effort, sub-maximal, progressive, carried out in eccentric mode |
| Kinetics on concentric or excentric mode during test of effortparticipants may receive 4 interventions sequentially during the protocol | Other | Kinetic in concentric mode, Kinetic in eccentric mode, Test of effort, sub-maximal, progressive, carried out in concentric mode, Test of effort, sub-maximal, progressive, carried out in eccentric mode |
Primary outcome
Measures of oxidation rate of lipid substrates at T2 visit and T3 visit
Time frame: Through effort test
The oxidation rate of lipid substrates is measured at 10% of VO2max, 20% of VO2max, 40% of VO2max and 50% of VO2max
10 secondary outcomes
Measures of oxidation rate of carbohydrates at T2 visit and T3 visit
Time frame: Through effort test
Measure of total energy expenditure at T2 visit and T3 visit
Time frame: Trough exercise
Measure of total energy expenditure at T2 visit and T3 visit
Time frame: immediatly after exercise
Measure of total energy expenditure at T2 visit and T3 visit
Time frame: through recovery after exercise, an average of 1 hour
Measure of total energy expenditure
Time frame: 30 min
Measure of energy expenditure during 6 hours of recovery after exercises
Time frame: 6 hours
Measures of substrates oxidation rates at T4 visit and T5 visit
Time frame: through effort test
Measures of quantities of oxidized substrates at T4 visit and T5 visit
Time frame: through effort test
Measures of quantities of carbohydrates at T4 visit and T5 visit
Time frame: Through energy expenditure measurment an average of 6 hours
Measures of quantities of fats at T4 visit and T5 visit
Time frame: Through energy expenditure measurment an average of 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
Related trials for Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice RANNOU principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test of effort on cycle on concentric or excentric mode and Kinetics on concentric or excentric mode during test of effort in people with Overweight and Healthy, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measures of oxidation rate of lipid substrates at T2 visit and T3 visit (time frame: Through effort test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.