Skeletal MuscleNCT06475391
The Effects of L-arginine Supplementation on Anaerobic Exercise Performance
A study testing L-arginine in people with Skeletal Muscle and Human Performance, run by University of Manitoba at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate if acute ingestion of L-arginine will enhance anaerobic exercise performance in young, healthy, and recreationally active adults. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Skeletal Muscle, Human Performance
- What is being tested?
- L-arginine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jun 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recreationally physically active individuals will be recruited for the study. In this context it means all participants perform 1-hour of exercise per day over 3-days per week at a minimum for 1-month. All participants will be between the ages of 18-39 years of age.
Who cannot join
- Exclusion criteria for the study includes: 1) smokers; 2) unhealthy (have cardiovascular, metabolic, neurological, or psychological disease); 3) taking medication for any condition; 4) any known allergy to the supplements of interest (L-arginine or placebo [dextrose]).
Trial locations and contacts
1 site in 1 country.
Mikal Thrones, BSc contact
Canada1 site, 1 recruiting
- Recruiting
Applied Research Centre; Active Living Centre
Winnipeg, Manitoba, R3T 2N2
Stephen M Cornish, PhD, 204-381-7296, Stephen.Cornish@umanitoba.ca
About this study
The purpose of this study is to evaluate if acute ingestion of L-arginine will enhance anaerobic exercise performance in young, healthy, and recreationally active adults.
Read the detailed description
After being enrolled in the study you will be measured on a number of parameters including: body circumferences, body composition via bioelectrical impedance analysis (BIA), height, weight, resting blood pressure, and resting heart rate.
All participants will be asked to complete the same protocol for this study. The study design is a randomized, double-blind, placebo controlled, cross-over type of study. What this means is that each participant in the study will complete two exercise sessions after ingesting either a placebo (dextrose - a sugar molecule) or the active ingredient [insert supplement] plus dextrose. Neither you nor the research assistant testing you on the exercise sessions will know which ingredient you are ingesting before each exercise trial (i.e., the double-blind portion of the study). We will also randomize the order of which supplement plus placebo or placebo alone you will ingest so neither you nor the research assistant testing will know this either. The cross-over part of the study is that you will complete 2 testing sessions to assess some physical performance variables (grip strength, jump height and power, and anaerobic energy system power output) with one-week of a wash-out period between them. This will allow us to compare the placebo session to the active nutritional supplement plus placebo condition to evaluate if the supplements improve exercise performance acutely.
You will also be asked to fill in a 24-hour food and fluid log for the period before your initial exercise test. Then you will be asked to repeat this food and fluid intake when completing the second session. No caffeine, alcohol, or vigorous exercise will be allowed for the 24-hours prior to each trial.
- Conditions
- Skeletal Muscle, Human Performance
- Being tested
- L-arginine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-arginineDietary supplement
2 grams iof L-arginine will be ingested before an acute testing bout of exercise tasks in 250 mL of cranberry juice.
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| L-arginine | Experimental | Participants will ingest 2 grams of L-arginine before completing three anaerobic exercise tasks (grip strength, vertical jump, and Wingate cycle ergometer test). Receives: Dietary Supplement: L-arginine |
| Placebo | Placebo comparator | Participants will ingest 2 grams of placebo (dextrose) before completing three anaerobic exercise tasks (grip strength, vertical jump, and Wingate cycle ergometer test). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip Strength
Grip strength measurement in kilograms of force produced on a hand held dynamometer.
Measured: 5 minutes
Counter movement vertical jump
Counter movement vertical jump performance height in centimeters.
Measured: 3 minutes
Wingate anaerobic cycle ergometer test
Maximum pedaling power output for 30 seconds of all-out sprinting on a cycle ergometer.
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start14 Jun 2024
- Primary completionSep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal MuscleStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475391
- Sponsor's protocol ID
- HE2024-0063
- Status last verified
- Jun 2024
- First submitted
- 20 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of L-arginine Supplementation on Anaerobic Exercise Performance
- ClinicalTrials.gov ID
- NCT06475391
- Acronym / sponsor ID
- HE2024-0063
- Conditions
- Skeletal Muscle, Human Performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate if acute ingestion of L-arginine will enhance anaerobic exercise performance in young, healthy, and recreationally active adults.
Detailed description
After being enrolled in the study you will be measured on a number of parameters including: body circumferences, body composition via bioelectrical impedance analysis (BIA), height, weight, resting blood pressure, and resting heart rate.
All participants will be asked to complete the same protocol for this study. The study design is a randomized, double-blind, placebo controlled, cross-over type of study. What this means is that each participant in the study will complete two exercise sessions after ingesting either a placebo (dextrose - a sugar molecule) or the active ingredient [insert supplement] plus dextrose. Neither you nor the research assistant testing you on the exercise sessions will know which ingredient you are ingesting before each exercise trial (i.e., the double-blind portion of the study). We will also randomize the order of which supplement plus placebo or placebo alone you will ingest so neither you nor the research assistant testing will know this either. The cross-over part of the study is that you will complete 2 testing sessions to assess some physical performance variables (grip strength, jump height and power, and anaerobic energy system power output) with one-week of a wash-out period between them. This will allow us to compare the placebo session to the active nutritional supplement plus placebo condition to evaluate if the supplements improve exercise performance acutely.
You will also be asked to fill in a 24-hour food and fluid log for the period before your initial exercise test. Then you will be asked to repeat this food and fluid intake when completing the second session. No caffeine, alcohol, or vigorous exercise will be allowed for the 24-hours prior to each trial.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-arginine | Experimental | Dietary Supplement: L-arginineParticipants will ingest 2 grams of L-arginine before completing three anaerobic exercise tasks (grip strength, vertical jump, and Wingate cycle ergometer test). |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants will ingest 2 grams of placebo (dextrose) before completing three anaerobic exercise tasks (grip strength, vertical jump, and Wingate cycle ergometer test). |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Recreationally physically active individuals will be recruited for the study. In this context it means all participants perform 1-hour of exercise per day over 3-days per week at a minimum for 1-month. All participants will be between the ages of 18-39 years of age.
Key exclusion criteria (1 listed)
- Exclusion criteria for the study includes: 1) smokers; 2) unhealthy (have cardiovascular, metabolic, neurological, or psychological disease); 3) taking medication for any condition; 4) any known allergy to the supplements of interest (L-arginine or placebo [dextrose]).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-arginine2 grams iof L-arginine will be ingested before an acute testing bout of exercise tasks in 250 mL of cranberry juice. | Dietary supplement | L-arginine |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Grip Strength
Time frame: 5 minutes
Grip strength measurement in kilograms of force produced on a hand held dynamometer.
Counter movement vertical jump
Time frame: 3 minutes
Counter movement vertical jump performance height in centimeters.
Wingate anaerobic cycle ergometer test
Time frame: 30 seconds
Maximum pedaling power output for 30 seconds of all-out sprinting on a cycle ergometer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikal Thrones, BSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-arginine in people with Skeletal Muscle and Human Performance, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen M Cornish, PhD (204-381-7296, Stephen.Cornish@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip Strength (time frame: 5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.