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

Not Applicable

Completed

• Conditions: Survival Training
• Interventions: Dietary Supplement: HMB-FA; Dietary Supplement: Placebo

• Registration Number: NCT02503007
• Lead Sponsor: Metabolic Technologies Inc.

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-07-16
• Study First Posted: 2015-07-20
• Primary Completion: 2015-09
• Status Verified: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2015-11-24
• Last Update Posted: 2015-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HMB-FA	HMB-FA	Active treatment consisting of 3 g of HMB-FA per day.
Placebo	Placebo	A placebo similar in composition and appearance to the experimental treatment.

Primary Outcome Measures

Name	Time	Method
Muscle Strength	Day 18	Hand grip strength will be measured using a hand-grip dynamometer.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IDF; 🇮🇱 Beersheva, Israel