Fuel Selection During Eccentric Cycling With Glucose Ingestion

May 16, 2022 updated by: Jonathan Tremblay, Université de Montréal

Fuel Selection During Eccentric Cycling: Comparison With Concentric Cycling and the Effect of Glucose Ingestion During Exercise

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cycling on a cycle ergometer typically requires repeated concentric muscle contractions to push on the pedals and produce mechanical work. An eccentric cycling ergometer has a motor that rotates the cranks with a predetermined torque, the cyclist needs to resist to the movement of the cranks. This leads to eccentric muscle contractions, the work is thus produced while the muscle is lengthening (negative work). This mode of exercise is known to produce a lower oxygen consumption (energy cost) for the same mechanical power output and also leads to muscle damage which can interfere with fuel selection.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H3C 3J7
        • Centre d'éducation physique et sportive de l'Université de Montréal (CEPSUM)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Concentric cycling with placebo ingestion
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 ingestion
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.
Behavioral: Constant load arm cranking
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.
Procedure: Expired gas sampling
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.
Procedure: Indirect respiratory calorimetry
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.
Procedure: Blood sampling
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.
Behavioral: Measure of maximal voluntary contraction force production
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.
Diagnostic test: Measure of muscle electrical activity (EMG)
Surface electrodes will be placed on the biceps and quadriceps to measure EMG throughout the exercise protocol.
Diagnostic test: Measure of central and cutaneous temperatures
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.
Diagnostic test: Measure of perceived exertion, pain perception and affective response
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".
Procedure: Measure of sweat and urine production
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.
Experimental: Concentric cycling with glucose ingestion
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 ingestion
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.
Behavioral: Constant load arm cranking
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.
Procedure: Expired gas sampling
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.
Procedure: Indirect respiratory calorimetry
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.
Procedure: Blood sampling
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.
Behavioral: Measure of maximal voluntary contraction force production
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.
Diagnostic test: Measure of muscle electrical activity (EMG)
Surface electrodes will be placed on the biceps and quadriceps to measure EMG throughout the exercise protocol.
Diagnostic test: Measure of central and cutaneous temperatures
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.
Diagnostic test: Measure of perceived exertion, pain perception and affective response
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".
Procedure: Measure of sweat and urine production
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.
Experimental: Eccentric cycling with placebo ingestion
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 ingestion
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.
Behavioral: Constant load arm cranking
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.
Procedure: Expired gas sampling
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.
Procedure: Indirect respiratory calorimetry
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.
Procedure: Blood sampling
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.
Behavioral: Measure of maximal voluntary contraction force production
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.
Diagnostic test: Measure of muscle electrical activity (EMG)
Surface electrodes will be placed on the biceps and quadriceps to measure EMG throughout the exercise protocol.
Diagnostic test: Measure of central and cutaneous temperatures
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.
Diagnostic test: Measure of perceived exertion, pain perception and affective response
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".
Procedure: Measure of sweat and urine production
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.
Experimental: Eccentric cycling with glucose ingestion
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 ingestion
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.
Behavioral: Constant load arm cranking
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.
Procedure: Expired gas sampling
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.
Procedure: Indirect respiratory calorimetry
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.
Procedure: Blood sampling
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.
Behavioral: Measure of maximal voluntary contraction force production
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.
Diagnostic test: Measure of muscle electrical activity (EMG)
Surface electrodes will be placed on the biceps and quadriceps to measure EMG throughout the exercise protocol.
Diagnostic test: Measure of central and cutaneous temperatures
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.
Diagnostic test: Measure of perceived exertion, pain perception and affective response
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".
Procedure: Measure of sweat and urine production
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Exogenous glucose oxidation
Time Frame: Average over the 35 minutes of eccentric or concentric exercise
Measured by indirect respiratory calorimetry combined with tracer techniques.
Average over the 35 minutes of eccentric or concentric exercise
Maximal voluntary force production
Time Frame: Change between baseline and end of exercise
Measured using isometric bilateral knee extensions
Change between baseline and end of exercise
Central and skin temperature
Time Frame: Average over the 35 minutes of eccentric or concentric exercise
Measured using a thermometric pill and skin-surface electrodes
Average over the 35 minutes of eccentric or concentric exercise
Perceived exertion
Time Frame: Average over the 35 minutes of eccentric or concentric exercise
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood insulin concentration
Time Frame: For 0 minutes corresponds to the beginning of exercise, at -31, -1, 14, 29, 44, 49, 59 and 69 minutes
Blood is sampled using a venous catheter over about 60 seconds. Following centrifugation to extract the plasma, a small sample is used to measure 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
Time Frame: For 0 minutes corresponds to the beginning of exercise, at -31, -1, 14, 29, 44, 49, 59 and 69 minutes
Blood is sampled using a venous catheter over about 60 seconds. Following centrifugation to extract the plasma, a small sample is used to measure 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
Time Frame: For 0 minutes corresponds to the beginning of exercise, at -31, -1, 14, 29, 44, 49, 59 and 69 minutes
Blood is sampled using a venous catheter over about 60 seconds. Following centrifugation to extract the plasma, a small sample is used to measure 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
Time Frame: For 0 minutes corresponds to the beginning of exercise, at -31, -1, 14, 29, 44, 49, 59 and 69 minutes
Blood is sampled using a venous catheter over about 60 seconds. Following centrifugation to extract the plasma, a small sample is used to measure 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
Time Frame: Average over the 35 minutes of eccentric or concentric exercise
Measured by indirect respiratory calorimetry corrected for urea excretion in sweat and urine
Average over the 35 minutes of eccentric or concentric exercise
Pain perception: VAS
Time Frame: Average over the 35 minutes of eccentric or concentric exercise
Visual analogue pain scale of 25 cm, relative distance converted to score on 100 points. Higher values correspond to greater pain sensation.
Average over the 35 minutes of eccentric or concentric exercise
Affective response
Time Frame: Average over the 35 minutes of eccentric or concentric exercise
Feeling scale, ranging from -5 to +5, reporting the mood (Hardy & Rejeski, 1989). -5 corresponds to very bad and +5 to very good.
Average over the 35 minutes of eccentric or concentric exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université de Montréal

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonathan Tremblay, PhD, Université de Montréal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • eccentric-exogenous

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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