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

Healthy Subjects Clinical Trial

Official title:

Effect of Oral ATP on Human Muscle Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141504
• Other study ID #: MTI2010-CS01
• Status: Completed
• Phase: Phase 1
• First received: June 9, 2010
• Last updated: January 9, 2012
• Start date: June 2010
• Est. completion date: October 2011

Study information

• Verified date: January 2012
• Source: Metabolic Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Dietary Supplement:
• PeakATP 250
The nutritional intervention provides for oral ingestion of 250 mg PeakATP per day
• Placebo
Placebo capsules that are comparable in size and color to the active comparator for blinding purposes
• PeakATP 400
The nutritional intervention provides for oral ingestion of 400 mg PeakATP per day
• 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

Locations

Country	Name	City	State
United States	Iowa State University	Ames	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Metabolic Technologies Inc.	Iowa State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Work Performed	The work and total work performed in 3 exercise fatigue tests given after 15 days of nutritional intervention.	Measured after 15 days of intervention	No
Secondary	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 after 15 days of intervention	No