search
Back to results

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

Primary Purpose

Overweight, Healthy, Men

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Test of effort on cycle on concentric or excentric mode
Kinetics on concentric or excentric mode during test of effort
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Energy expenditure, eccentric training, concentric training, oxidized substrates

Eligibility Criteria

20 Years - 40 Years (Adult)MaleAccepts 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).

Sites / Locations

  • CHU clermont-ferrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Test of effort, sub-maximal, progressive, carried out in eccentric mode

Test of effort, sub-maximal, progressive, carried out in concentric mode

Kinetic in eccentric mode

Kinetic in concentric mode

Arm 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%.

The exercise will start at 10% of VO2max. However, every six minutes, the level of VO2max will be increased by 10%, up to 50%.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Measure of total energy expenditure at T2 visit and T3 visit
At the T2 visit and T3 visit, the total energy expenditure is measured
Measure of total energy expenditure at T2 visit and T3 visit
At the T2 visit and T3 visit, the total energy expenditure is measured
Measure of total energy expenditure at T2 visit and T3 visit
At the T2 visit and T3 visit, the total energy expenditure is measured
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.
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
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
Measures of quantities of oxidized substrates at T4 visit and T5 visit
The quantities of oxidized substrates (carbohydrates, fats, proteins) are measured during exercises
Measures of quantities of carbohydrates at T4 visit and T5 visit
The quantities of oxidized carbohydrates are measured during the measure of energy expenditure
Measures of quantities of fats at T4 visit and T5 visit
The quantities of fats are measured during the measure of energy expenditure

Full Information

First Posted
June 30, 2021
Last Updated
April 4, 2022
Sponsor
University Hospital, Clermont-Ferrand
search

1. Study Identification

Unique Protocol Identification Number
NCT05319704
Brief Title
Specificities of the Eccentric Exercise: Energy Expenditure and Nature of Oxidized Substrates
Acronym
Speed-Enso
Official Title
Specificities of the Eccentric Exercise: Energy Expenditure and Nature of Oxidized Substrates
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 17, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Healthy, Men
Keywords
Energy expenditure, eccentric training, concentric training, oxidized substrates

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
participants may receive 4 differents interventions sequentially during the protocol
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test of effort, sub-maximal, progressive, carried out in eccentric mode
Arm Type
Active Comparator
Arm 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%.
Arm Title
Test of effort, sub-maximal, progressive, carried out in concentric mode
Arm Type
Placebo Comparator
Arm 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%.
Arm Title
Kinetic in eccentric mode
Arm Type
Active Comparator
Arm 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.
Arm Title
Kinetic in concentric mode
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Test of effort on cycle on concentric or excentric mode
Intervention Description
participants may receive 4 interventions sequentially during the protocol
Intervention Type
Other
Intervention Name(s)
Kinetics on concentric or excentric mode during test of effort
Intervention Description
participants may receive 4 interventions sequentially during the protocol
Primary Outcome Measure Information:
Title
Measures of oxidation rate of lipid substrates at T2 visit and T3 visit
Description
The oxidation rate of lipid substrates is measured at 10% of VO2max, 20% of VO2max, 40% of VO2max and 50% of VO2max
Time Frame
Through effort test
Secondary Outcome Measure Information:
Title
Measures of oxidation rate of carbohydrates at T2 visit and T3 visit
Description
The oxidation rate of carbohydrates is measured at10% of VO2max, 20% of VO2max, 40% of VO2max and 50% of VO2max
Time Frame
Through effort test
Title
Measure of total energy expenditure at T2 visit and T3 visit
Description
At the T2 visit and T3 visit, the total energy expenditure is measured
Time Frame
Trough exercise
Title
Measure of total energy expenditure at T2 visit and T3 visit
Description
At the T2 visit and T3 visit, the total energy expenditure is measured
Time Frame
immediatly after exercise
Title
Measure of total energy expenditure at T2 visit and T3 visit
Description
At the T2 visit and T3 visit, the total energy expenditure is measured
Time Frame
through recovery after exercise, an average of 1 hour
Title
Measure of total energy expenditure
Description
the total energy expenditure is measured during constant-power cycle ergometer tests. This secondary outcome measure will be measured during eccentric and concentric exercises.
Time Frame
30 min
Title
Measure of energy expenditure during 6 hours of recovery after exercises
Description
the energy expenditure is measured during constant-power cycle ergometer tests. This secondary outcome measure will be measured during both kinetics
Time Frame
6 hours
Title
Measures of substrates oxidation rates at T4 visit and T5 visit
Description
The oxidation rates of substrates are measured during exercises performed at 30% of VO2max
Time Frame
through effort test
Title
Measures of quantities of oxidized substrates at T4 visit and T5 visit
Description
The quantities of oxidized substrates (carbohydrates, fats, proteins) are measured during exercises
Time Frame
through effort test
Title
Measures of quantities of carbohydrates at T4 visit and T5 visit
Description
The quantities of oxidized carbohydrates are measured during the measure of energy expenditure
Time Frame
Through energy expenditure measurment an average of 6 hours
Title
Measures of quantities of fats at T4 visit and T5 visit
Description
The quantities of fats are measured during the measure of energy expenditure
Time Frame
Through energy expenditure measurment an average of 6 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise Laclautre
Phone
334.73.754.963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice RANNOU
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU clermont-ferrand
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
First Name & Middle Initial & Last Name & Degree
Fabrice RANNOU

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs