ExerciseNCT01941368
The Effects of β-Hydroxy-β-methylbutyrate Free Acid and High-Intensity Interval Training
A study testing HMB-FA and High Intensity Interval Training in people with Exercise, run by Metabolic Technologies Inc. at 1 site in United States.
Trial summary
Objectives: 1) Determine the effect of 4-weeks of high intensity interval training (HIIT) and free acid form β-Hydroxy-β-methylbutyrate (HMB-FA) on VO2peak, lactate threshold, critical power, anaerobic working capacity and neuromuscular economy in a population of endurance trained individuals. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- HMB-FA and High Intensity Interval Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Dec 2013
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recreationally-trained individuals with a VO2peak>40 ml∙kg-1∙min-1.
- Free of any physical limitations as determined by the Confidential Medical and Activity questionnaire and/or PAR-Q
- Between the ages of 18 and 35
Who cannot join
- Inability to perform physical exercise, as determined by the Confidential Medical and Activity questionnaire and/or PAR-Q
- Any chronic illness that causes continuous medical care
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida, Sport and Exercise Science
Orlando, Florida, 32816
About this study
Official title: The Effects of β-Hydroxy-β-methylbutyrate Free Acid Gel and High-Intensity Interval Training on Quadriceps Muscle Architecture and Quality, Neuromuscular Economy, and Metabolic Performance in Recreationally Trained Individuals
Objectives: 1) Determine the effect of 4-weeks of high intensity interval training (HIIT) and free acid form β-Hydroxy-β-methylbutyrate (HMB-FA) on VO2peak, lactate threshold, critical power, anaerobic working capacity and neuromuscular economy in a population of endurance trained individuals. 2) Determine the effect of 4-weeks of HIIT and HMB-FA on changes in skeletal muscle physiological cross-sectional area (PCSA=Volume/Fascicle length) and muscle quality (MQ=echo intensity) in the rectus femoris and vastus lateralis.
Subjects: Fifty males and females between the ages of 18 - 35 will be recruited to participate in this study. Subject will be randomized to one of three groups: a control group (CTL), an HIIT only group (HIIT) or a group which will take the amino acid metabolite HMB and perform HIIT (HMB-HIIT). Individuals assigned to CTL will undergo baseline testing. They will then be asked to continue their normal exercise routine for 4 weeks and will undergo post-testing after this time period.
Study Protocol: Two testing sessions, on nonconsecutive days, will occur at least 72 hours prior to the start of the training period. The same testing protocols will be repeated at the end of the 4-week training period. Testing protocols include performance testing (VO2peak, lactate threshold, critical power, anaerobic working capacity and neuromuscular economy) and anthropometric measures (physiological cross-sectional area and muscle quality). The training protocol for individuals in the experimental groups will consist of 4-weeks of high intensity interval training with three sessions per week on an electronically braked cycle ergometer. Individual work -loads will be calculated based on the outcomes from each participant's preliminary testing.
- Conditions
- Exercise
- Being tested
- Placebo, HMB-FA, High Intensity Interval Training
- Keywords
- Performance, Aerobic Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
HMB-FADietary supplement
Also called beta-hydroxy-beta-methylbutyrate free acid (HMB-FA)
High Intensity Interval TrainingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Individuals assigned to Control Group will undergo baseline testing and then be asked to continue their normal exercise routine for 4 weeks and will undergo post-testing (visits 16 and 17) after this time period. |
| Placebo + High-Intesnity Interval Training (HIIT) | Placebo comparator | On training days, individuals will consume 1 gram of placebo 30 min prior to training, 1gram placebo 1 hour post training, and 1gram placebo 3 hours post training. On non-training days, individuals will consume placebo 3 times per day (8am, 12pm and 4pm). Receives: Dietary Supplement: Placebo; Procedure: High Intensity Interval Training |
| HMB-FA + HIIT | Active comparator | On training days, individuals will consume 1 gram HMB-FA 30 min prior to training, 1gram HMB-FA 1 hour post training, and 1gram HMB-FA 3 hours post training. On non-training days, individuals will consume HMB-FA 3 times per day (8am, 12pm and 4pm). Receives: Dietary Supplement: HMB-FA; Procedure: High Intensity Interval Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2peak/Ventilatory Threshold/fatigue threshold
A continuous graded exercise test will be performed on an electronically-braked cycle ergometer to determine maximal oxygen consumption (VO2peak) and the peak power output (PPO) in watts (W) at VO2peak.
Measured: Change from baseline after four weeks of high intensity interval training
Secondary outcomes (1)
EMG Activity Assessment
To assess EMG activity, a bipolar surface electrode arrangement will be placed over the muscles of the quadriceps. The EMG signals will be expressed as root mean square (RMS) amplitude values. During the leg extensor trial, electromyography (EMG) root mean square (RMS) amplitude values will be recorded
Measured: Change from baseline after four weeks of high intensity interval training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionDec 2013
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 ExerciseStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metabolic Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffery Stout, PhD, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941368
- Sponsor's protocol ID
- MTI2013-CS03
- Other IDs
- 13-257
- Status last verified
- Mar 2014
- First submitted
- 4 Sep 2013
- Last updated
- 17 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Robinson EH 4th, Stout JR, Miramonti AA, Fukuda DH, Wang R, Townsend JR, Mangine GT, Fragala MS, Hoffman JR. High-intensity interval training and beta-hydroxy-beta-methylbutyric free acid improves aerobic power and metabolic thresholds. J Int Soc Sports Nutr. 2014 Apr 26;11:16. doi: 10.1186/1550-2783-11-16. eCollection 2014.
PubMed 24782684
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of β-Hydroxy-β-methylbutyrate Free Acid Gel and High-Intensity Interval Training on Quadriceps Muscle Architecture and Quality, Neuromuscular Economy, and Metabolic Performance in Recreationally Trained Individuals
- ClinicalTrials.gov ID
- NCT01941368
- Acronym / sponsor ID
- MTI2013-CS03
- Conditions
- Exercise
- Keywords
- Performance, Aerobic Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Metabolic Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Sep 2013 (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.
Objectives: 1) Determine the effect of 4-weeks of high intensity interval training (HIIT) and free acid form β-Hydroxy-β-methylbutyrate (HMB-FA) on VO2peak, lactate threshold, critical power, anaerobic working capacity and neuromuscular economy in a population of endurance trained individuals. 2) Determine the effect of 4-weeks of HIIT and HMB-FA on changes in skeletal muscle physiological cross-sectional area (PCSA=Volume/Fascicle length) and muscle quality (MQ=echo intensity) in the rectus femoris and vastus lateralis.
Subjects: Fifty males and females between the ages of 18 - 35 will be recruited to participate in this study. Subject will be randomized to one of three groups: a control group (CTL), an HIIT only group (HIIT) or a group which will take the amino acid metabolite HMB and perform HIIT (HMB-HIIT). Individuals assigned to CTL will undergo baseline testing. They will then be asked to continue their normal exercise routine for 4 weeks and will undergo post-testing after this time period.
Study Protocol: Two testing sessions, on nonconsecutive days, will occur at least 72 hours prior to the start of the training period. The same testing protocols will be repeated at the end of the 4-week training period. Testing protocols include performance testing (VO2peak, lactate threshold, critical power, anaerobic working capacity and neuromuscular economy) and anthropometric measures (physiological cross-sectional area and muscle quality). The training protocol for individuals in the experimental groups will consist of 4-weeks of high intensity interval training with three sessions per week on an electronically braked cycle ergometer. Individual work -loads will be calculated based on the outcomes from each participant's preliminary testing.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Individuals assigned to Control Group will undergo baseline testing and then be asked to continue their normal exercise routine for 4 weeks and will undergo post-testing (visits 16 and 17) after this time period. |
| Placebo + High-Intesnity Interval Training (HIIT) | Placebo comparator | Dietary Supplement: Placebo, Procedure: High Intensity Interval TrainingOn training days, individuals will consume 1 gram of placebo 30 min prior to training, 1gram placebo 1 hour post training, and 1gram placebo 3 hours post training. On non-training days, individuals will consume placebo 3 times per day (8am, 12pm and 4pm). |
| HMB-FA + HIIT | Active comparator | Dietary Supplement: HMB-FA, Procedure: High Intensity Interval TrainingOn training days, individuals will consume 1 gram HMB-FA 30 min prior to training, 1gram HMB-FA 1 hour post training, and 1gram HMB-FA 3 hours post training. On non-training days, individuals will consume HMB-FA 3 times per day (8am, 12pm and 4pm). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Recreationally-trained individuals with a VO2peak>40 ml∙kg-1∙min-1.
- Free of any physical limitations as determined by the Confidential Medical and Activity questionnaire and/or PAR-Q
- Between the ages of 18 and 35
Key exclusion criteria (2 listed)
- Inability to perform physical exercise, as determined by the Confidential Medical and Activity questionnaire and/or PAR-Q
- Any chronic illness that causes continuous medical care
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 |
|---|---|---|
| Placebo | Dietary supplement | Placebo + High-Intesnity Interval Training (HIIT) |
| HMB-FAAlso: beta-hydroxy-beta-methylbutyrate free acid (HMB-FA) | Dietary supplement | HMB-FA + HIIT |
| High Intensity Interval Training | Procedure or surgery | HMB-FA + HIIT, Placebo + High-Intesnity Interval Training (HIIT) |
Primary outcome
VO2peak/Ventilatory Threshold/fatigue threshold
Time frame: Change from baseline after four weeks of high intensity interval training
A continuous graded exercise test will be performed on an electronically-braked cycle ergometer to determine maximal oxygen consumption (VO2peak) and the peak power output (PPO) in watts (W) at VO2peak.
1 secondary outcome
EMG Activity Assessment
Time frame: Change from baseline after four weeks of high intensity interval training
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 17 Mar 2014.
- Derived from this study: PubMed 24782684Robinson EH 4th, Stout JR, Miramonti AA, Fukuda DH, Wang R, Townsend JR, Mangine GT, Fragala MS, Hoffman JR. High-intensity interval training and beta-hydroxy-beta-methylbutyric free acid improves aerobic power and metabolic thresholds. J Int Soc Sports Nutr. 2014 Apr 26;11:16. doi: 10.1186/1550-2783-11-16. eCollection 2014.
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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.
Jeffery Stout, PhD principal investigator
University of Central Florida
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-FA and High Intensity Interval Training in people with Exercise, 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?
The sponsor lists 3 inclusion and 2 exclusion criteria. 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 17 Mar 2014. 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?
VO2peak/Ventilatory Threshold/fatigue threshold (time frame: Change from baseline after four weeks of high intensity interval training). 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 NCT01941368, 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 17 Mar 2014.