Muscle Fatigue Caused by Repetitive Muscle ExerciseNCT02093611
Study to Examine the Effects of ATP Supplementation on Muscle Excitability and Reaction Time During and Following a Repeated Sprint Bout
A study testing ATP in people with Muscle Fatigue Caused by Repetitive Muscle Exercise, run by Metabolic Technologies Inc. at 1 site in United States.
Trial summary
We hypothesize that adenosine-5'-triphosphate (ATP) supplementation will be able to enhance motor unit recruitment while simultaneously blunting the decline in power and reaction time that is typically seen during repetitive sprints. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Fatigue Caused by Repetitive Muscle Exercise
- What is being tested?
- ATP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Aug 2015
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Agree to eating a diet approved by a registered dietician consisting of the following by caloric percentages: 15-20% protein, 44-55% carbohydrate, and 25-30% fat.
- Must not have taken performance enhancing supplements for at least 3 months prior to the study start,
- Must be a non-smoker.
- Must not be taking amino acid supplements.
- Must not be using anabolic or catabolic hormones.
- Must not be taking any medications known to influence variables to be measured in the study.
Who cannot join
- Will not agree to eating a diet approved by a registered dietician consisting of the following by caloric percentages: 15-20% protein, 44-55% carbohydrate, and 25-30% fat.
- Has taken performance enhancing supplements for at least 3 months prior to the study start,
- Is currently a non-smoker.
- Is currently taking amino acid supplements.
- Is currently using anabolic or catabolic hormones.
- Is currently taking medications known to influence variables to be measured in the study.
Trial locations and contacts
1 site in 1 country.
About this study
We hypothesize that adenosine-5'-triphosphate (ATP) supplementation will be able to enhance motor unit recruitment while simultaneously blunting the decline in power and reaction time that is typically seen during repetitive sprints. This will give researchers a better understanding of the mechanism by which ATP supplementation can augment power, especially under high fatiguing conditions.
Read the detailed description
Healthy participants of similar training status as previously tested will be enrolled into the study. The participants will be randomly assigned to either placebo supplementation or to 400 mg ATP per day for 14 days. The supplements will be taken in the morning and the last dose will be taken 30 min prior to testing on the last day. Testing will be performed at baseline and after the 14 days of supplementation. Ten successive sprints will be conducted on the Wingate apparatus as this has been previously demonstrated to decrease muscle excitability. After the sprints, muscle excitability, reaction time, and vertical jump power will be measured. In addition a blood sample will be obtained before and after supplementation and complete blood hematology and chemistry analyses will be performed. It is expected that ATP supplementation may help maintain muscle excitability and power after the successive sprint sessions.
- Being tested
- Placebo, ATP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Also called Placebo Comparator
ATPDietary supplement
Also called Peak ATP
400 mg of ATP
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | This arm will serve as the placebo supplementation. Receives: Dietary Supplement: Placebo |
| ATP | Active comparator | This arm will serve as the treatment intervention, ATP Receives: Dietary Supplement: ATP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Excitability
Muscle excitability will be measured using Delsys Wireless Electromyography (EMG) sensors.
Measured: Day 14
Secondary outcomes (1)
Power
Muscle power will be measured using the Wingate and vertical jump power measures.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startJul 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Fatigue Caused by Repetitive Muscle ExerciseStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metabolic Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Tampa
- Responsible party
- Sponsor
- Investigators
- John A Rathmacher, PhD, Study director, Metabolic Technologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093611
- Sponsor's protocol ID
- MTI2013-CS04
- Status last verified
- Sep 2015
- First submitted
- 18 Mar 2014
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Examine the Effects of ATP Supplementation on Muscle Excitability and Reaction Time During and Following a Repeated Sprint Bout
- ClinicalTrials.gov ID
- NCT02093611
- Acronym / sponsor ID
- MTI2013-CS04
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Metabolic Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Tampa
- Study start
- Jul 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 21 Mar 2014 (estimated)
- 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.
We hypothesize that adenosine-5'-triphosphate (ATP) supplementation will be able to enhance motor unit recruitment while simultaneously blunting the decline in power and reaction time that is typically seen during repetitive sprints. This will give researchers a better understanding of the mechanism by which ATP supplementation can augment power, especially under high fatiguing conditions.
Detailed description
Healthy participants of similar training status as previously tested will be enrolled into the study. The participants will be randomly assigned to either placebo supplementation or to 400 mg ATP per day for 14 days. The supplements will be taken in the morning and the last dose will be taken 30 min prior to testing on the last day. Testing will be performed at baseline and after the 14 days of supplementation. Ten successive sprints will be conducted on the Wingate apparatus as this has been previously demonstrated to decrease muscle excitability. After the sprints, muscle excitability, reaction time, and vertical jump power will be measured. In addition a blood sample will be obtained before and after supplementation and complete blood hematology and chemistry analyses will be performed. It is expected that ATP supplementation may help maintain muscle excitability and power after the successive sprint sessions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThis arm will serve as the placebo supplementation. |
| ATP | Active comparator | Dietary Supplement: ATPThis arm will serve as the treatment intervention, ATP |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Agree to eating a diet approved by a registered dietician consisting of the following by caloric percentages: 15-20% protein, 44-55% carbohydrate, and 25-30% fat.
- Must not have taken performance enhancing supplements for at least 3 months prior to the study start,
- Must be a non-smoker.
- Must not be taking amino acid supplements.
- Must not be using anabolic or catabolic hormones.
Key exclusion criteria (6 listed)
- Will not agree to eating a diet approved by a registered dietician consisting of the following by caloric percentages: 15-20% protein, 44-55% carbohydrate, and 25-30% fat.
- Has taken performance enhancing supplements for at least 3 months prior to the study start,
- Is currently a non-smoker.
- Is currently taking amino acid supplements.
- Is currently using anabolic or catabolic hormones.
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 |
|---|---|---|
| PlaceboAlso: Placebo Comparator | Dietary supplement | Placebo |
| ATPAlso: Peak ATP400 mg of ATP | Dietary supplement | ATP |
Primary outcome
Muscle Excitability
Time frame: Day 14
Muscle excitability will be measured using Delsys Wireless Electromyography (EMG) sensors.
1 secondary outcome
Power
Time frame: Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
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Ageing, Muscle Fatigue Caused by Repetitive Muscle Exercise
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.
John A Rathmacher, PhD study director
Metabolic Technologies Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATP in people with Muscle Fatigue Caused by Repetitive Muscle Exercise, run by Metabolic Technologies Inc. at 1 site in United States.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 28 Sep 2015. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Excitability (time frame: Day 14). 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 28 Sep 2015.