Effects of 14-days of HMB-free Acid on Changes in Muscle During 4-days of Survival Training

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Survival Training

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: HMB-FA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 27 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>A placebo similar in composition and appearance to the experimental treatment. | Dietary Supplement: Placebo<br> <br> |
| Experimental: HMB-FA<br>Active treatment consisting of 3 g of HMB-FA per day. | Dietary Supplement: HMB-FA<br> <br> * Other names: beta-hydroxy-beta-methylbutyric acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Strength | Hand grip strength will be measured using a hand-grip dynamometer. | Day 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Power | Vertical Jump power will be measured using a linear transducer. | Day 18 | 
| Muscle Morphology | Muscle morphology will be measured using a 3.0 Tesla Magnetic Resonance Imaging device. | Day 18 | 
| Muscle Mass | Muscle mass will be performed using bioelectrical impedance | Day 18 | 
| Blood Biochemical Analysis | Blood biochemical analysis will be performed using an ELISA assay. | Day 18 | 
| Urine Biochemical Analysis | Urine biochemical analysis will be performed using an ELISA assay. | Day 18 |