NCT01508338

Brief Summary

The purpose of this study is to

  • determine the effects of 12 weeks of HMB free acid gel, ATP, and HMB free acid gel plus ATP supplementation in trained individuals during a periodized training program on skeletal muscle hypertrophy, body composition, strength, force, velocity, and peak power during loaded and unloaded vertical jumps. Additionally, the study will determine if either supplementation protocol prevents the typical decay seen in performance following an overreaching cycle performed in the 9th and 10th weeks of the study. Finally, the study will elucidate the mechanisms of action of supplementation on protein breakdown by analyzing serum indices of muscle damage (CK, LDH) and anabolic status (Testosterone:Cortisol ratio) as well as a urinary indicator of protein breakdown (3-methylhistidine). We hypothesize that under these conditions that the supplementation protocols will augment skeletal muscle hypertrophy, strength, and power and that HMB will blunt increases in serum indices of muscle damage, and urinary indices of protein breakdown.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable

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

January 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

9 months

First QC Date

January 9, 2012

Last Update Submit

July 28, 2017

Conditions

Keywords

HMB beta-hydroxy-beta-methylbutyrateATP (adenosine-triphosphate)trained athletes

Outcome Measures

Primary Outcomes (1)

  • Increased muscle strength, force, and power after intense weight training

    12 weeks

Secondary Outcomes (1)

  • Increased muscle hypertrophy

    12 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

HMB

EXPERIMENTAL
Dietary Supplement: HMB

ATP and HMB

EXPERIMENTAL
Dietary Supplement: Peak ATP and HMB

ATP

EXPERIMENTAL
Dietary Supplement: ATP

Interventions

PlaceboDIETARY_SUPPLEMENT

An oral placebo capsule will be taken each morning and three dosages of a placebo gel containing polydextrose will be taken 3 times daily for 12 weeks.

Placebo
HMBDIETARY_SUPPLEMENT

A placebo capsule will be taken each morning and three dosages of HMB gel, each providing 1 g of HMB, will be taken daily for a total of 3 g HMB per day for 12 weeks.

HMB
Peak ATP and HMBDIETARY_SUPPLEMENT

One capsule containing 400 mg of Peak ATP will be taken in the morning and three dosages of HMB gel, each providing 1 g of HMB, will be taken daily for a total of 3 g HMB per day for 12 weeks.

ATP and HMB
ATPDIETARY_SUPPLEMENT

One capsule containing 400 mg of Peak ATP will be taken daily in the morning and three dosages of a placebo gel containing polydextrose will be taken 3 times daily for 12 weeks.

ATP

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Have 3 years minimum of free weight training experience
  • Can squat a minimum of 1.5 times their bodyweight
  • Can bench press a minimum equal to their bodyweight
  • Can deadlift a minimum of 1.5 times their bodyweight
  • Are free of musculoskeletal injuries
  • Have not taken creatine or HMB supplements for 6 weeks
  • Are not taking amino acid supplements
  • Are not using anabolic or catabolic hormones
  • Are not taking medications that may interfere with study measurements
  • Are not users of tobacco products

You may not qualify if:

  • Do not have 3 years minimum of free weight training experience
  • Can not squat a minimum of 1.5 times their bodyweight
  • Can not bench press a minimum equal to their bodyweight
  • Can not deadlift a minimum of 1.5 times their bodyweight
  • Are not free of musculoskeletal injuries
  • Have not taken creatine or HMB supplements in the past 6 weeks
  • Are currently taking amino acid supplements
  • Are using anabolic or catabolic hormones
  • Are taking medications that may interfere with study measurements
  • Use of tobacco products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tampa

Tampa, Florida, 33606, United States

Location

Related Publications (1)

  • Wilson JM, Joy JM, Lowery RP, Roberts MD, Lockwood CM, Manninen AH, Fuller JC, De Souza EO, Baier SM, Wilson SM, Rathmacher JA. Effects of oral adenosine-5'-triphosphate supplementation on athletic performance, skeletal muscle hypertrophy and recovery in resistance-trained men. Nutr Metab (Lond). 2013 Sep 22;10(1):57. doi: 10.1186/1743-7075-10-57.

MeSH Terms

Interventions

Adenosine Triphosphate

Intervention Hierarchy (Ancestors)

Adenine NucleotidesPurine NucleotidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • John A Rathmacher, PhD

    Metabolic Technologies Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2012

First Posted

January 11, 2012

Study Start

January 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

August 1, 2017

Record last verified: 2017-07

Locations