NCT01141504

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

January 10, 2012

Status Verified

January 1, 2012

Enrollment Period

1.3 years

First QC Date

June 9, 2010

Last Update Submit

January 9, 2012

Conditions

Keywords

Supplemental ATPMuscle Work PerformedMuscle Fatigue

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Decrease in work performed in each successive test

    Measured after 15 days of intervention

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Oral placebo capsules similar in color and size to the intervention

Dietary Supplement: Placebo

PeakATP 250

ACTIVE COMPARATOR

Oral supplement capsules containing 250 mg/day of PeakATP

Dietary Supplement: PeakATP 250

PeakATP 400

ACTIVE COMPARATOR

Oral supplement capsules containing 400 mg/day of PeakATP

Dietary Supplement: PeakATP 400

PeakATP 400 plus proprietary blend

ACTIVE COMPARATOR

Oral supplement capsules containing 400 mg/day of PeakATP plus a proprietary blend

Dietary Supplement: PeakATP 400 plus proprietary blend

Interventions

PeakATP 250DIETARY_SUPPLEMENT

The nutritional intervention provides for oral ingestion of 250 mg PeakATP per day

PeakATP 250
PlaceboDIETARY_SUPPLEMENT

Placebo capsules that are comparable in size and color to the active comparator for blinding purposes

Placebo
PeakATP 400DIETARY_SUPPLEMENT

The nutritional intervention provides for oral ingestion of 400 mg PeakATP per day

PeakATP 400

The nutritional intervention provides for oral ingestion of 400 mg PeakATP per day plus a proprietary blend of additional nutrients

PeakATP 400 plus proprietary blend

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iowa State University

Ames, Iowa, 50010, United States

Location

Study Officials

  • John A Rathmacher, PhD

    Metabolic Technologies Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2010

First Posted

June 10, 2010

Study Start

June 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

January 10, 2012

Record last verified: 2012-01

Locations