Clinical trial NCT02503007: Effects of 14-days of HMB-free Acid on Changes in Muscle During 4-days of Survival Training
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Survival Training
Lead sponsor: Metabolic Technologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: Koach Sport and Nutrition
First posted: 2015-07-20
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Muscle Strength
timeFrame: Day 18
Secondary outcomes:
measure: Muscle Power
timeFrame: Day 18
measure: Muscle Morphology
timeFrame: Day 18
measure: Muscle Mass
timeFrame: Day 18
measure: Blood Biochemical Analysis
timeFrame: Day 18
measure: Urine Biochemical Analysis
timeFrame: Day 18
Other outcomes:
Locations:
city: Beersheva
country: Israel
facility: IDF
Study officials:
affiliation: International Diabetes Federation
name: Ishay Osterfeld, MD
role: PRINCIPAL_INVESTIGATOR
References: