Healthy Experienced Weight Training MalesNCT01508338
The Effects of HMB, ATP, and HMB Plus ATP on Muscle Mass, Strength, and Power in Resistance Trained Athletes
A study testing HMB, Peak ATP and HMB and ATP in people with Healthy Experienced Weight Training Males, run by Metabolic Technologies Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Experienced Weight Training Males
- What is being tested?
- HMB, Peak ATP and HMB and ATP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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
- Being tested
- Placebo, HMB, Peak ATP and HMB, ATP
- Keywords
- HMB beta-hydroxy-beta-methylbutyrate, ATP (adenosine-triphosphate), trained athletes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| HMB | Experimental | Not described Receives: Dietary Supplement: HMB |
| ATP and HMB | Experimental | Not described Receives: Dietary Supplement: Peak ATP and HMB |
| ATP | Experimental | Not described Receives: Dietary Supplement: ATP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased muscle strength, force, and power after intense weight training
Measured: 12 weeks
Secondary outcomes (1)
Increased muscle hypertrophy
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Experienced Weight Training MalesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metabolic Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Tampa
- Responsible party
- Sponsor
- Investigators
- John A Rathmacher, PhD, Study director, Metabolic Technologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508338
- Sponsor's protocol ID
- MTI2012-CS01
- Status last verified
- Jul 2017
- First submitted
- 9 Jan 2012
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24330670
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of HMB, ATP, and HMB Plus ATP on Muscle Mass, Strength, and Power in Resistance Trained Athletes
- ClinicalTrials.gov ID
- NCT01508338
- Acronym / sponsor ID
- MTI2012-CS01
- Keywords
- HMB beta-hydroxy-beta-methylbutyrate, ATP (adenosine-triphosphate), trained athletes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Metabolic Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Tampa
- Study start
- Jan 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 11 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAn 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. | Dietary supplement | Placebo |
| HMBA 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. | Dietary supplement | HMB |
| Peak ATP and HMBOne 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. | Dietary supplement | ATP and HMB |
| ATPOne 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. | Dietary supplement | ATP |
Primary outcome
Increased muscle strength, force, and power after intense weight training
Time frame: 12 weeks
1 secondary outcome
Increased muscle hypertrophy
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Derived from this study: PubMed 24330670Wilson 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Rathmacher, PhD study director
Metabolic Technologies Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HMB, Peak ATP and HMB and ATP in people with Healthy Experienced Weight Training Males, run by Metabolic Technologies Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased muscle strength, force, and power after intense weight training (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01508338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.