The Effects of HMB, ATP, and HMB Plus ATP on Muscle Mass, Strength, and Power in Resistance Trained Athletes

July 28, 2017 updated by: Metabolic Technologies Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In a randomized and double blind study the subjects will consume either placebo supplements, HMB supplement, ATP supplement, or HMB plus ATP supplements for 12 weeks. While consuming the supplements the subjects will undergo an extensive resistance training program designed to train all major muscle groups. An additional overreaching training cycle during weeks 9 and 10 which will involve a high-volume, hypertrophy style training program.

Subject testing will consist of the following:

  • Strength and power at weeks 0, 1, 4, 8, 9, 10, and 12
  • Range of motion and muscle soreness at weeks 0, 1, 8, 9, and 10
  • Body composition and muscle assessments at weeks 0, 1, 4, 8, 9, 10, and 12
  • Body fat assessments at weeks 0, 4, 8, and 12
  • Blood biochemical measurements at weeks 0, 1, 4, 8, 9, 10, and 12
  • Urinary analysis for protein breakdown (3-methylhistidine) at 0, 1, 8, 9, and 10 weeks

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33606
        • University of Tampa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 26 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Subjects must meet all of the inclusion criteria to participate in the study.

  • 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

All candidates meeting any one of the exclusion criteria will not be enrolled into the study.

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Dietary supplement: Placebo
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.
Experimental: HMB
Dietary supplement: HMB
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.
Experimental: ATP and HMB
Dietary supplement: Peak ATP and HMB
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.
Experimental: ATP
Dietary supplement: ATP
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Increased muscle strength, force, and power after intense weight training
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Increased muscle hypertrophy
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Metabolic Technologies Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Tampa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: John A Rathmacher, PhD, Metabolic Technologies Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MTI2012-CS01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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