NCT03995693

Brief Summary

This study compares fuel selection during eccentric and concentric cycling, with (placebo) or without glucose ingestion during exercise. After a 2-week familiarization and habituation with the ergometers, subjects will complete four experimental conditions in a randomized order: concentric with placebo, eccentric with placebo, concentric with glucose, eccentric with glucose.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 24, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 24, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

2.3 years

First QC Date

May 24, 2019

Last Update Submit

May 16, 2022

Conditions

Keywords

eccentric exercise13C-glucoseexercise mode

Outcome Measures

Primary Outcomes (4)

  • Exogenous glucose oxidation

    Measured by indirect respiratory calorimetry combined with tracer techniques.

    Average over the 35 minutes of eccentric or concentric exercise

  • Maximal voluntary force production

    Measured using isometric bilateral knee extensions

    Change between baseline and end of exercise

  • Central and skin temperature

    Measured using a thermometric pill and skin-surface electrodes

    Average over the 35 minutes of eccentric or concentric exercise

  • Perceived exertion

    Measured using a Category Ratio scale on 100 points (CR100), 0 signifies no exertion and 100 being maximal effort.

    Average over the 35 minutes of eccentric or concentric exercise

Secondary Outcomes (7)

  • Blood insulin concentration

    For 0 minutes corresponds to the beginning of exercise, at -31, -1, 14, 29, 44, 49, 59 and 69 minutes

  • Blood glucose concentration

    For 0 minutes corresponds to the beginning of exercise, at -31, -1, 14, 29, 44, 49, 59 and 69 minutes

  • Blood free-fatty acid concentration

    For 0 minutes corresponds to the beginning of exercise, at -31, -1, 14, 29, 44, 49, 59 and 69 minutes

  • Blood lactate concentration

    For 0 minutes corresponds to the beginning of exercise, at -31, -1, 14, 29, 44, 49, 59 and 69 minutes

  • Total carbohydrate, fat and protein oxidation

    Average over the 35 minutes of eccentric or concentric exercise

  • +2 more secondary outcomes

Study Arms (4)

Concentric cycling with placebo ingestion

EXPERIMENTAL

Participants will complete 45 minutes of arm cranking at an intensity corresponding to 30% of the concentric cycling VO2max, followed by 35 minutes of CONCENTRIC cycling on a recumbent ergometer at the same VO2. A PLACEBO solution (water with a non-caloric sweetener) will be ingested 30 min prior to starting exercise and every 15 min thereafter, until the exercise is completed. Indirect respiratory calorimetry, expired gas sampling, blood sampling will occur will be performed 4 minutes before each ingestion.

Dietary Supplement: Solution ingestionBehavioral: Constant load arm crankingProcedure: Expired gas samplingProcedure: Indirect respiratory calorimetryProcedure: Blood samplingBehavioral: Measure of maximal voluntary contraction force productionDiagnostic Test: Measure of muscle electrical activity (EMG)Diagnostic Test: Measure of central and cutaneous temperaturesDiagnostic Test: Measure of perceived exertion, pain perception and affective responseProcedure: Measure of sweat and urine production

Concentric cycling with glucose ingestion

EXPERIMENTAL

Participants will complete 45 minutes of arm cranking at an intensity corresponding to 30% of the concentric cycling VO2max, followed by 35 minutes of concentric cycling on a recumbent ergometer at the same VO2. A GLUCOSE solution (glucose with a trace amount of 13C) will be ingested 30 min prior to starting exercise and every 15 min thereafter, until the exercise is completed. Indirect respiratory calorimetry, expired gas sampling, blood sampling will occur will be performed 4 minutes before each ingestion.

Dietary Supplement: Solution ingestionBehavioral: Constant load arm crankingProcedure: Expired gas samplingProcedure: Indirect respiratory calorimetryProcedure: Blood samplingBehavioral: Measure of maximal voluntary contraction force productionDiagnostic Test: Measure of muscle electrical activity (EMG)Diagnostic Test: Measure of central and cutaneous temperaturesDiagnostic Test: Measure of perceived exertion, pain perception and affective responseProcedure: Measure of sweat and urine production

Eccentric cycling with placebo ingestion

EXPERIMENTAL

Participants will complete 45 minutes of arm cranking at an intensity corresponding to 30% of the concentric cycling VO2max, followed by 35 minutes of ECCENTRIC cycling on a recumbent ergometer at the same VO2. A PLACEBO solution (water with a non-caloric sweetener) will be ingested 30 min prior to starting exercise and every 15 min thereafter, until the exercise is completed. Indirect respiratory calorimetry, expired gas sampling, blood sampling will occur will be performed 4 minutes before each ingestion.

Dietary Supplement: Solution ingestionBehavioral: Constant load arm crankingProcedure: Expired gas samplingProcedure: Indirect respiratory calorimetryProcedure: Blood samplingBehavioral: Measure of maximal voluntary contraction force productionDiagnostic Test: Measure of muscle electrical activity (EMG)Diagnostic Test: Measure of central and cutaneous temperaturesDiagnostic Test: Measure of perceived exertion, pain perception and affective responseProcedure: Measure of sweat and urine production

Eccentric cycling with glucose ingestion

EXPERIMENTAL

Participants will complete 45 minutes of arm cranking at an intensity corresponding to 30% of the concentric cycling VO2max, followed by 35 minutes of ECCENTRIC cycling on a recumbent ergometer at the same VO2. A GLUCOSE solution (glucose with a trace amount of 13C) will be ingested 30 min prior to starting exercise and every 15 min thereafter, until the exercise is completed. Indirect respiratory calorimetry, expired gas sampling, blood sampling will occur will be performed 4 minutes before each ingestion.

Dietary Supplement: Solution ingestionBehavioral: Constant load arm crankingProcedure: Expired gas samplingProcedure: Indirect respiratory calorimetryProcedure: Blood samplingBehavioral: Measure of maximal voluntary contraction force productionDiagnostic Test: Measure of muscle electrical activity (EMG)Diagnostic Test: Measure of central and cutaneous temperaturesDiagnostic Test: Measure of perceived exertion, pain perception and affective responseProcedure: Measure of sweat and urine production

Interventions

Solution ingestionDIETARY_SUPPLEMENT

Two ingestion modalities will be attributed (participant is blinded) in random order: a placebo and a glucose solution. The placebo contains water and a non-caloric sweetener (stevia) in order to reproduce the taste of the glucose solution. The glucose solution contains 6% glucose per volume, labelled with 13C. Both solutions will be administered in 8 doses: a bolus (333 mL) at rest, 30 minutes before the start of exercise, 167 mL immediately before exercise, 167 mL every 15 minutes during arm cranking, 125 mL immediately before concentric or eccentric pedalling and at 15 and 25 minutes of this last exercise period. In total, 1250 mL of solution will be administered during the experimental protocol.

Concentric cycling with glucose ingestionConcentric cycling with placebo ingestionEccentric cycling with glucose ingestionEccentric cycling with placebo ingestion

The participants will perform 45 minutes of arm cranking on a specialized ergometer at a power output corresponding to 30% of their concentric cycling VO2max, previously measured.

Concentric cycling with glucose ingestionConcentric cycling with placebo ingestionEccentric cycling with glucose ingestionEccentric cycling with placebo ingestion

Subjects will be asked, twice, to provide a forced expiration into a 10 mL plastic tube in order to collect a sample expired gases. This procedure will be done immediately before blood sampling and ingestion of the solution.

Concentric cycling with glucose ingestionConcentric cycling with placebo ingestionEccentric cycling with glucose ingestionEccentric cycling with placebo ingestion

A mouthpiece and nose plug will be placed on the subject and expired gases will be analyzed by a metabolic cart during 3 minutes. This procedure will be done immediately before expired gas collection, blood sampling and ingestion of the solution.

Concentric cycling with glucose ingestionConcentric cycling with placebo ingestionEccentric cycling with glucose ingestionEccentric cycling with placebo ingestion

A catheter will be inserted in an antecubital vein and a saline solution will be continuously perfused to maintain vein open. 10 mL of blood will be collected immediately before ingesting the solution for a total of 80 mL.

Concentric cycling with glucose ingestionConcentric cycling with placebo ingestionEccentric cycling with glucose ingestionEccentric cycling with placebo ingestion

Maximal voluntary bilateral knee extensions (3 trials of 3-4 seconds each) will be performed on a chair equipped with force sensors to measure peak force production. These measurements will be done before the first ingestion, immediately before exercise, during the transition between arm cranking and concentric or eccentric cycling, and at the end of the exercise protocol.

Concentric cycling with glucose ingestionConcentric cycling with placebo ingestionEccentric cycling with glucose ingestionEccentric cycling with placebo ingestion

Surface electrodes will be placed on the biceps and quadriceps to measure EMG throughout the exercise protocol.

Concentric cycling with glucose ingestionConcentric cycling with placebo ingestionEccentric cycling with glucose ingestionEccentric cycling with placebo ingestion

Wireless sensors will be placed on the skin of the arm, chest, back, abdomen, thigh and calf using adhesive tape. A wireless thermometric pill will be ingested the morning of the experiment. These will allow the measurement of skin and central temperatures throughout the exercise protocol.

Concentric cycling with glucose ingestionConcentric cycling with placebo ingestionEccentric cycling with glucose ingestionEccentric cycling with placebo ingestion

100 points scales (CR100) will be used to measure perceived exertion and pain perception immediately before ingesting the gas sampling. At the same time, affective responses will be assessed using the "Feeling scale".

Concentric cycling with glucose ingestionConcentric cycling with placebo ingestionEccentric cycling with glucose ingestionEccentric cycling with placebo ingestion

Sweat production and sampling will be performed by measuring body weight before and after exercise, after voiding the bladder. Mass loss through the urine and gases will be accounted for in order to compute sweat production. A sweat sample will be collected using a cotton gauze placed into a plastic collector affixed in the upper back of the participants. A urine sample will be taken from the urine collected at the end of the exercise period. Urine and sweat volumes along with respective urea concentrations will be used to compute protein oxidation during exercise.

Concentric cycling with glucose ingestionConcentric cycling with placebo ingestionEccentric cycling with glucose ingestionEccentric cycling with placebo ingestion

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Low alcohol consumption (\<3 drinks/week)
  • Non-smokers
  • Not regularly taking medication for a known pathology
  • Regularly practices endurance sports (cycling, running, etc.)

You may not qualify if:

  • Intolerant to glucose (according to WHO standards)
  • Musculoskeletal injury or illness affecting exercise performance
  • Failure to respect protocol guidelines (diet, exercise prior to experimentation, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'éducation physique et sportive de l'Université de Montréal (CEPSUM)

Montreal, Quebec, H3C 3J7, Canada

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Blood Specimen CollectionElectromyography

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesElectrodiagnosisMyography

Study Officials

  • Jonathan Tremblay, PhD

    Université de Montréal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Opaque bottles to administer beverages with similar sweet taste.
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 24, 2019

First Posted

June 24, 2019

Study Start

August 1, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

May 17, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations