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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy Subjects
 Dietary Supplement: PeakATP 250
Dietary Supplement: Placebo
Dietary Supplement: PeakATP 400
Dietary Supplement: PeakATP 400 plus proprietary blend
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of Oral ATP on Human Muscle Performance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Metabolic Technologies Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 16
Study Start Date: June 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Oral placebo capsules similar in color and size to the intervention
 Dietary Supplement: Placebo
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
 Dietary Supplement: PeakATP 250
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
 Dietary Supplement: PeakATP 400
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
 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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141504

Locations
United States, Iowa
Iowa State University
Ames, Iowa, United States, 50010
Sponsors and Collaborators
Metabolic Technologies Inc.
Iowa State University
Investigators
Principal Investigator: John A Rathmacher, PhD Metabolic Technologies Inc.
  More Information

No publications provided

Responsible Party: Metabolic Technologies Inc.
ClinicalTrials.gov Identifier: NCT01141504     History of Changes
Other Study ID Numbers: MTI2010-CS01
Study First Received: June 9, 2010
Last Updated: January 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Metabolic Technologies Inc.:
Supplemental ATP
Muscle Work Performed
Muscle Fatigue

ClinicalTrials.gov processed this record on May 21, 2013