Healthy SubjectsPhase 1NCT01141504
Effect of Oral Adenosine-triphosphate (ATP) on Human Muscle Performance
A Phase 1 study testing PeakATP 250, PeakATP 400 and PeakATP 400 plus proprietary blend in people with Healthy Subjects, run by Metabolic Technologies Inc. at 1 site in United States.
Trial summary
Adenosine-triphosphate (ATP) serves as the sole energy source for muscle contraction. Therefore human performance of brief maximal exercise is limited, in part, by the availability of ATP to the contracting muscle. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- PeakATP 250, PeakATP 400 and PeakATP 400 plus proprietary blend
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Oct 2011
- Phase
- Phase 1
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No major medical conditions;
- Able to perform fatigue testing procedures;
- Not currently taking prescription medications;
- Not currently taking dietary supplements (a daily multi-vitamin not exceeding RDA is permitted)
Who cannot join
- Major medical condition affecting metabolism or general function;
- Not able to perform fatigue testing;
- Taking prescription medications;
- Taking a dietary supplement other than a multi-vitamin not exceeding RDA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Oral ATP on Human Muscle Performance
Adenosine-triphosphate (ATP) serves as the sole energy source for muscle contraction. Therefore human performance of brief maximal exercise is limited, in part, by the availability of ATP to the contracting muscle. Because muscle ATP storage is small (enough to sustain maximal exercise for less than 1 second), factors that enhance either storage or resynthesis of ATP may have a positive impact on repeated muscle contractions. The current study will test the hypothesis that increasing ATP availability to muscle via oral supplementation will improve performance of repeated high intensity exercise as measured by a) work performed in each of the three 50 contraction fatigue tests, b) sum of total work performed, and c) percentage decrement in total work from the first to third third 50 contraction test.
Read the detailed description
To date we have studied 10 subjects who have followed through with all 3 of the original interventions (Placebo, 250 mg PeakATP/d and 400 mg PeakATP/d). Currently we have received approval and are expanding the study with 5 additional subjects who will receive the Placebo, 400 mg PeakATP/d and the 400 mg PealATP/d plus proprietary blend interventions.
- Conditions
- Healthy Subjects
- Being tested
- PeakATP 250, Placebo, PeakATP 400, PeakATP 400 plus proprietary blend
- Keywords
- Supplemental ATP, Muscle Work Performed, Muscle Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeakATP 250Dietary supplement
The nutritional intervention provides for oral ingestion of 250 mg PeakATP per day
PlaceboDietary supplement
Placebo capsules that are comparable in size and color to the active comparator for blinding purposes
PeakATP 400Dietary supplement
The nutritional intervention provides for oral ingestion of 400 mg PeakATP per day
PeakATP 400 plus proprietary blendDietary supplement
The nutritional intervention provides for oral ingestion of 400 mg PeakATP per day plus a proprietary blend of additional nutrients
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Oral placebo capsules similar in color and size to the intervention Receives: Dietary Supplement: Placebo |
| PeakATP 250 | Active comparator | Oral supplement capsules containing 250 mg/day of PeakATP Receives: Dietary Supplement: PeakATP 250 |
| PeakATP 400 | Active comparator | Oral supplement capsules containing 400 mg/day of PeakATP Receives: Dietary Supplement: PeakATP 400 |
| PeakATP 400 plus proprietary blend | Active comparator | Oral supplement capsules containing 400 mg/day of PeakATP plus a proprietary blend Receives: Dietary Supplement: PeakATP 400 plus proprietary blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work Performed
The work and total work performed in 3 exercise fatigue tests given after 15 days of nutritional intervention.
Measured: Measured after 15 days of intervention
Secondary outcomes (1)
Decrease in work performed in each successive test
The decrease in total work performed in each of 3 successive fatigue tests will be measured and used as a measure of muscle fatigability after 15 days of nutritional intervention
Measured: Measured after 15 days of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metabolic Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Iowa State University
- Responsible party
- Sponsor
- Investigators
- John A Rathmacher, PhD, Principal investigator, Metabolic Technologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141504
- Sponsor's protocol ID
- MTI2010-CS01
- Status last verified
- Jan 2012
- First submitted
- 9 Jun 2010
- Last updated
- 10 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral ATP on Human Muscle Performance
- ClinicalTrials.gov ID
- NCT01141504
- Acronym / sponsor ID
- MTI2010-CS01
- Conditions
- Healthy Subjects
- Keywords
- Supplemental ATP, Muscle Work Performed, Muscle Fatigue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Metabolic Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Iowa State University
- Study start
- Jun 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 10 Jun 2010 (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.
Adenosine-triphosphate (ATP) serves as the sole energy source for muscle contraction. Therefore human performance of brief maximal exercise is limited, in part, by the availability of ATP to the contracting muscle. Because muscle ATP storage is small (enough to sustain maximal exercise for less than 1 second), factors that enhance either storage or resynthesis of ATP may have a positive impact on repeated muscle contractions. The current study will test the hypothesis that increasing ATP availability to muscle via oral supplementation will improve performance of repeated high intensity exercise as measured by a) work performed in each of the three 50 contraction fatigue tests, b) sum of total work performed, and c) percentage decrement in total work from the first to third third 50 contraction test.
Detailed description
To date we have studied 10 subjects who have followed through with all 3 of the original interventions (Placebo, 250 mg PeakATP/d and 400 mg PeakATP/d). Currently we have received approval and are expanding the study with 5 additional subjects who will receive the Placebo, 400 mg PeakATP/d and the 400 mg PealATP/d plus proprietary blend interventions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOral placebo capsules similar in color and size to the intervention |
| PeakATP 250 | Active comparator | Dietary Supplement: PeakATP 250Oral supplement capsules containing 250 mg/day of PeakATP |
| PeakATP 400 | Active comparator | Dietary Supplement: PeakATP 400Oral supplement capsules containing 400 mg/day of PeakATP |
| PeakATP 400 plus proprietary blend | Active comparator | Dietary Supplement: PeakATP 400 plus proprietary blendOral supplement capsules containing 400 mg/day of PeakATP plus a proprietary blend |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- No major medical conditions;
- Able to perform fatigue testing procedures;
- Not currently taking prescription medications;
- Not currently taking dietary supplements (a daily multi-vitamin not exceeding RDA is permitted)
Key exclusion criteria (4 listed)
- Major medical condition affecting metabolism or general function;
- Not able to perform fatigue testing;
- Taking prescription medications;
- Taking a dietary supplement other than a multi-vitamin not exceeding RDA
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 |
|---|---|---|
| PeakATP 250The nutritional intervention provides for oral ingestion of 250 mg PeakATP per day | Dietary supplement | PeakATP 250 |
| PlaceboPlacebo capsules that are comparable in size and color to the active comparator for blinding purposes | Dietary supplement | Placebo |
| PeakATP 400The nutritional intervention provides for oral ingestion of 400 mg PeakATP per day | Dietary supplement | PeakATP 400 |
| PeakATP 400 plus proprietary blendThe nutritional intervention provides for oral ingestion of 400 mg PeakATP per day plus a proprietary blend of additional nutrients | Dietary supplement | PeakATP 400 plus proprietary blend |
Primary outcome
Work Performed
Time frame: Measured after 15 days of intervention
The work and total work performed in 3 exercise fatigue tests given after 15 days of nutritional intervention.
1 secondary outcome
Decrease in work performed in each successive test
Time frame: Measured after 15 days of intervention
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 10 Jan 2012.
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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.
John A Rathmacher, PhD principal investigator
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 Phase 1 study testing PeakATP 250, PeakATP 400 and PeakATP 400 plus proprietary blend in people with Healthy Subjects, 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 4 inclusion and 4 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 10 Jan 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Work Performed (time frame: Measured after 15 days of intervention). 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 10 Jan 2012.