- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02503007
Effects of 14-days of HMB-free Acid on Changes in Muscle During 4-days of Survival Training
November 24, 2015 updated by: Metabolic Technologies Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
27
Phase
- 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
-
-
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Beersheva, Israel
- IDF
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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
Ages Eligible for Study
16 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
A placebo similar in composition and appearance to the experimental treatment.
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Experimental: HMB-FA
Active treatment consisting of 3 g of HMB-FA per day.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Strength
Time Frame: Day 18
|
Hand grip strength will be measured using a hand-grip dynamometer.
|
Day 18
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Power
Time Frame: Day 18
|
Vertical Jump power will be measured using a linear transducer.
|
Day 18
|
Muscle Morphology
Time Frame: Day 18
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Muscle morphology will be measured using a 3.0 Tesla Magnetic Resonance Imaging device.
|
Day 18
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Muscle Mass
Time Frame: Day 18
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Muscle mass will be performed using bioelectrical impedance
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Day 18
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Blood Biochemical Analysis
Time Frame: Day 18
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Blood biochemical analysis will be performed using an ELISA assay.
|
Day 18
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Urine Biochemical Analysis
Time Frame: Day 18
|
Urine biochemical analysis will be performed using an ELISA assay.
|
Day 18
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ishay Osterfeld, MD, International Diabetes Federation
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
July 1, 2015
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
July 15, 2015
First Submitted That Met QC Criteria
July 16, 2015
First Posted (Estimate)
July 20, 2015
Study Record Updates
Last Update Posted (Estimate)
November 25, 2015
Last Update Submitted That Met QC Criteria
November 24, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- MTI2015-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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