Effect of Oral Adenosine-triphosphate (ATP) on Human Muscle Performance

This study has been completed.
Sponsor:
Collaborator:
Iowa State University
Information provided by (Responsible Party):
Metabolic Technologies Inc.
ClinicalTrials.gov Identifier:
NCT01141504
First received: June 9, 2010
Last updated: January 9, 2012
Last verified: January 2012

June 9, 2010
January 9, 2012
June 2010
October 2011   (final data collection date for primary outcome measure)
Work Performed [ Time Frame: Measured after 15 days of intervention ] [ Designated as safety issue: No ]
The work and total work performed in 3 exercise fatigue tests given after 15 days of nutritional intervention.
Same as current
Complete list of historical versions of study NCT01141504 on ClinicalTrials.gov Archive Site
Decrease in work performed in each successive test [ Time Frame: Measured after 15 days of intervention ] [ Designated as safety issue: No ]
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
Same as current
Not Provided
Not Provided
 
Effect of Oral Adenosine-triphosphate (ATP) on Human Muscle Performance
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Healthy Subjects
  • Dietary Supplement: PeakATP 250
    The nutritional intervention provides for oral ingestion of 250 mg PeakATP per day
  • Dietary Supplement: Placebo
    Placebo capsules that are comparable in size and color to the active comparator for blinding purposes
  • Dietary Supplement: PeakATP 400
    The nutritional intervention provides for oral ingestion of 400 mg PeakATP per day
  • Dietary Supplement: PeakATP 400 plus proprietary blend
    The nutritional intervention provides for oral ingestion of 400 mg PeakATP per day plus a proprietary blend of additional nutrients
  • Placebo Comparator: Placebo
    Oral placebo capsules similar in color and size to the intervention
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: PeakATP 250
    Oral supplement capsules containing 250 mg/day of PeakATP
    Intervention: Dietary Supplement: PeakATP 250
  • Active Comparator: PeakATP 400
    Oral supplement capsules containing 400 mg/day of PeakATP
    Intervention: Dietary Supplement: PeakATP 400
  • Active Comparator: PeakATP 400 plus proprietary blend
    Oral supplement capsules containing 400 mg/day of PeakATP plus a proprietary blend
    Intervention: Dietary Supplement: PeakATP 400 plus proprietary blend
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01141504
MTI2010-CS01
No
Metabolic Technologies Inc.
Metabolic Technologies Inc.
Iowa State University
Principal Investigator: John A Rathmacher, PhD Metabolic Technologies Inc.
Metabolic Technologies Inc.
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP