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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05319704
Other study ID # RBHP 2018 RICHARD
Secondary ID 2019-A00082-55
Status Recruiting
Phase N/A
First received
Last updated
Start date February 17, 2021
Est. completion date August 2023

Study information

Verified date June 2021
Source University Hospital, Clermont-Ferrand
Contact Lise Laclautre
Phone 334.73.754.963
Email promo_interne_drci@chu-clermontferrand.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date August 2023
Est. primary completion date August 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 40 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Test of effort on cycle on concentric or excentric mode
participants may receive 4 interventions sequentially during the protocol
Kinetics on concentric or excentric mode during test of effort
participants may receive 4 interventions sequentially during the protocol

Locations

Country Name City State
France CHU clermont-ferrand Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Through effort test
Secondary 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 Through effort test
Secondary Measure of total energy expenditure at T2 visit and T3 visit At the T2 visit and T3 visit, the total energy expenditure is measured Trough exercise
Secondary Measure of total energy expenditure at T2 visit and T3 visit At the T2 visit and T3 visit, the total energy expenditure is measured immediatly after exercise
Secondary Measure of total energy expenditure at T2 visit and T3 visit At the T2 visit and T3 visit, the total energy expenditure is measured through recovery after exercise, an average of 1 hour
Secondary 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. 30 min
Secondary 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 6 hours
Secondary 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 through effort test
Secondary Measures of quantities of oxidized substrates at T4 visit and T5 visit The quantities of oxidized substrates (carbohydrates, fats, proteins) are measured during exercises through effort test
Secondary Measures of quantities of carbohydrates at T4 visit and T5 visit The quantities of oxidized carbohydrates are measured during the measure of energy expenditure Through energy expenditure measurment an average of 6 hours
Secondary Measures of quantities of fats at T4 visit and T5 visit The quantities of fats are measured during the measure of energy expenditure Through energy expenditure measurment an average of 6 hours
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