NCT05319704

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2021

Completed
9 months until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

April 8, 2022

Status Verified

June 1, 2021

Enrollment Period

2.5 years

First QC Date

June 30, 2021

Last Update Submit

April 4, 2022

Conditions

OverweightHealthyMen

Keywords

Energy expenditureeccentric trainingconcentric trainingoxidized substrates

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Measures of oxidation rate of carbohydrates at T2 visit and T3 visit

    Through effort test

  • Measure of total energy expenditure at T2 visit and T3 visit

    Trough exercise

  • Measure of total energy expenditure at T2 visit and T3 visit

    immediatly after exercise

  • Measure of total energy expenditure at T2 visit and T3 visit

    through recovery after exercise, an average of 1 hour

  • Measure of total energy expenditure

    30 min

  • +5 more secondary outcomes

Study Arms (4)

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%.

Other: Test of effort on cycle on concentric or excentric modeOther: 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%.

Other: Test of effort on cycle on concentric or excentric modeOther: 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.

Other: Test of effort on cycle on concentric or excentric modeOther: 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.

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

Interventions

Test of effort on cycle on concentric or excentric modeOTHER

participants may receive 4 interventions sequentially during the protocol

Kinetic in concentric modeKinetic in eccentric modeTest of effort, sub-maximal, progressive, carried out in concentric modeTest of effort, sub-maximal, progressive, carried out in eccentric mode
Kinetics on concentric or excentric mode during test of effortOTHER

participants may receive 4 interventions sequentially during the protocol

Kinetic in concentric modeKinetic in eccentric modeTest of effort, sub-maximal, progressive, carried out in concentric modeTest of effort, sub-maximal, progressive, carried out in eccentric mode

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

RECRUITING

MeSH Terms

Conditions

OverweightMultiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Study Officials

  • Fabrice RANNOU

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963promo_interne_drci@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: participants may receive 4 differents interventions sequentially during the protocol
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2021

First Posted

April 8, 2022

Study Start

February 17, 2021

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

April 8, 2022

Record last verified: 2021-06

Locations

FR(1)