- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01141504
Effect of Oral Adenosine-triphosphate (ATP) on Human Muscle Performance
January 9, 2012 updated by: Metabolic Technologies Inc.
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
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
-
-
Iowa
-
Ames, Iowa, United States, 50010
- Iowa State University
-
-
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
Ages Eligible for Study
20 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
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: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Oral placebo capsules similar in color and size to the intervention
|
Placebo capsules that are comparable in size and color to the active comparator for blinding purposes
|
Active Comparator: PeakATP 250
Oral supplement capsules containing 250 mg/day of PeakATP
|
The nutritional intervention provides for oral ingestion of 250 mg PeakATP per day
|
Active Comparator: PeakATP 400
Oral supplement capsules containing 400 mg/day of PeakATP
|
The nutritional intervention provides for oral ingestion of 400 mg PeakATP per day
|
Active Comparator: PeakATP 400 plus proprietary blend
Oral supplement capsules containing 400 mg/day of PeakATP plus a proprietary blend
|
The nutritional intervention provides for oral ingestion of 400 mg PeakATP per day plus a proprietary blend of additional nutrients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Measured after 15 days of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decrease in work performed in each successive test
Time Frame: Measured after 15 days of intervention
|
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 after 15 days of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: John A Rathmacher, PhD, Metabolic Technologies Inc.
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
June 1, 2010
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
June 9, 2010
First Submitted That Met QC Criteria
June 9, 2010
First Posted (Estimate)
June 10, 2010
Study Record Updates
Last Update Posted (Estimate)
January 10, 2012
Last Update Submitted That Met QC Criteria
January 9, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- MTI2010-CS01
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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