Survival TrainingNCT02503007
Effects of 14-days of HMB-free Acid on Changes in Muscle During 4-days of Survival Training
A study testing HMB-FA in people with Survival Training, run by Metabolic Technologies Inc. at 1 site in Israel.
Trial summary
Sustained high-intensity activity, such as survival training with little nourishment available, can result in a loss of muscle performance. This study will examine the effects of a nutritional supplement to maintain muscle and muscle performance during this period. Read more about this study
- Who is it for?
- Ages 18 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Survival Training
- What is being tested?
- HMB-FA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2015to Oct 2015
- 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 27 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 27 Years of age
- Soldier members of Special Operations
- Healthy as assessed by the Unit's Medical Officers
- Subject provides written and dated informed consent to participate
Who cannot join
- A history of medical or surgical events that may significantly affect the study outcome, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders
- Use of medications that may affect the study outcomes
- Use of nutritional supplements (such as protein drinks, creatine, HMB and vitamins) in the 3 months prior to the start of the study
- Subject is currently participating in another clinical trial or has received an investigational product within thirty days prior to screening/enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of 14-days of HMB-Free Acid on Changes in Muscle Architecture, Blood Markers of Muscle Damage and Performance During 4-Days of Survival Training
Sustained high-intensity activity, such as survival training with little nourishment available, can result in a loss of muscle performance. This study will examine the effects of a nutritional supplement to maintain muscle and muscle performance during this period.
Read the detailed description
Sustained high intensity activity that is often accompanied by sleep and nutrient deprivation is a common characteristic of survival training. Survival training is a requirement in the preparation of pilots, where they learn evasion and survival skills that they may need to avoid capture in a situation in which they have bailed from their plane. The physiological stresses associated with the nature of these operations often results in significant decrements in lean body mass, muscle size and muscle endurance and power. During a sudden evacuation from the aircraft the pilot only takes a small survival bag. There is a limit to what can possibly be put in this bag. However, the ability to provide a dietary supplement specifically targeting muscle may provide an important resource for maintaining muscle mass and performance. Thus, the purpose of this study is to determine the efficacy of 14 days of HMB-FA ingestion on maintaining muscle architecture and muscle performance during 4-days of survival training. In addition, anabolic and catabolic markers of stress, inflammation and muscle damage will be assessed.
- Conditions
- Survival Training
- Being tested
- Placebo, HMB-FA
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-methylbutyric acid
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | A placebo similar in composition and appearance to the experimental treatment. Receives: Dietary Supplement: Placebo |
| HMB-FA | Experimental | Active treatment consisting of 3 g of HMB-FA per day. Receives: Dietary Supplement: HMB-FA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Strength
Hand grip strength will be measured using a hand-grip dynamometer.
Measured: Day 18
Secondary outcomes (5)
Muscle Power
Vertical Jump power will be measured using a linear transducer.
Measured: Day 18
Muscle Morphology
Muscle morphology will be measured using a 3.0 Tesla Magnetic Resonance Imaging device.
Measured: Day 18
Muscle Mass
Muscle mass will be performed using bioelectrical impedance
Measured: Day 18
Blood Biochemical Analysis
Blood biochemical analysis will be performed using an ELISA assay.
Measured: Day 18
Urine Biochemical Analysis
Urine biochemical analysis will be performed using an ELISA assay.
Measured: Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Survival TrainingStudies 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, Care provider, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metabolic Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Koach Sport and Nutrition
- Responsible party
- Sponsor
- Investigators
- Ishay Osterfeld, MD, Principal investigator, International Diabetes Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503007
- Sponsor's protocol ID
- MTI2015-CS01
- Status last verified
- Oct 2015
- First submitted
- 15 Jul 2015
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of 14-days of HMB-Free Acid on Changes in Muscle Architecture, Blood Markers of Muscle Damage and Performance During 4-Days of Survival Training
- ClinicalTrials.gov ID
- NCT02503007
- Acronym / sponsor ID
- MTI2015-CS01
- Conditions
- Survival Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Metabolic Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Koach Sport and Nutrition
- Study start
- Jul 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 Jul 2015 (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.
Sustained high-intensity activity, such as survival training with little nourishment available, can result in a loss of muscle performance. This study will examine the effects of a nutritional supplement to maintain muscle and muscle performance during this period.
Detailed description
Sustained high intensity activity that is often accompanied by sleep and nutrient deprivation is a common characteristic of survival training. Survival training is a requirement in the preparation of pilots, where they learn evasion and survival skills that they may need to avoid capture in a situation in which they have bailed from their plane. The physiological stresses associated with the nature of these operations often results in significant decrements in lean body mass, muscle size and muscle endurance and power. During a sudden evacuation from the aircraft the pilot only takes a small survival bag. There is a limit to what can possibly be put in this bag. However, the ability to provide a dietary supplement specifically targeting muscle may provide an important resource for maintaining muscle mass and performance. Thus, the purpose of this study is to determine the efficacy of 14 days of HMB-FA ingestion on maintaining muscle architecture and muscle performance during 4-days of survival training. In addition, anabolic and catabolic markers of stress, inflammation and muscle damage will be assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboA placebo similar in composition and appearance to the experimental treatment. |
| HMB-FA | Experimental | Dietary Supplement: HMB-FAActive treatment consisting of 3 g of HMB-FA per day. |
Who may qualify
- Ages
- 18 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 to 27 Years of age
- Soldier members of Special Operations
- Healthy as assessed by the Unit's Medical Officers
- Subject provides written and dated informed consent to participate
Key exclusion criteria (4 listed)
- A history of medical or surgical events that may significantly affect the study outcome, including cardiovascular disease, metabolic, renal, hepatic, or musculoskeletal disorders
- Use of medications that may affect the study outcomes
- Use of nutritional supplements (such as protein drinks, creatine, HMB and vitamins) in the 3 months prior to the start of the study
- Subject is currently participating in another clinical trial or has received an investigational product within thirty days prior to screening/enrollment
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 |
| HMB-FAAlso: beta-hydroxy-beta-methylbutyric acid | Dietary supplement | HMB-FA |
Primary outcome
Muscle Strength
Time frame: Day 18
Hand grip strength will be measured using a hand-grip dynamometer.
5 secondary outcomes
Muscle Power
Time frame: Day 18
Muscle Morphology
Time frame: Day 18
Muscle Mass
Time frame: Day 18
Blood Biochemical Analysis
Time frame: Day 18
Urine Biochemical Analysis
Time frame: Day 18
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 25 Nov 2015.
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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.
Ishay Osterfeld, MD principal investigator
International Diabetes Federation
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 in people with Survival Training, run by Metabolic Technologies Inc. at 1 site in Israel.
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 4 inclusion and 4 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 25 Nov 2015. 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 Israel. 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?
Muscle Strength (time frame: Day 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2015.