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OpenTrials
Completed

NCT Number: NCT02503007

Effects of 14-days of HMB-free Acid on Changes in Muscle 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.

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Key information

Conditions

Age range

18 year–27 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IDF

Beersheva, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Dietary Supplement

HMB-FA

Dietary Supplement

Other names: beta-hydroxy-beta-methylbutyric acid

Primary outcomes

  1. Muscle Strength

    Time frame: Day 18

    Hand grip strength will be measured using a hand-grip dynamometer.

Secondary outcomes

  1. Muscle Power

    Time frame: Day 18

    Vertical Jump power will be measured using a linear transducer.

  2. Muscle Morphology

    Time frame: Day 18

    Muscle morphology will be measured using a 3.0 Tesla Magnetic Resonance Imaging device.

  3. Muscle Mass

    Time frame: Day 18

    Muscle mass will be performed using bioelectrical impedance

  4. Blood Biochemical Analysis

    Time frame: Day 18

    Blood biochemical analysis will be performed using an ELISA assay.

  5. Urine Biochemical Analysis

    Time frame: Day 18

    Urine biochemical analysis will be performed using an ELISA assay.

Sponsors and collaborators

Lead sponsor

Metabolic Technologies Inc.

Industry

Collaborators

  • Koach Sport and Nutrition

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 20, 2015
Registry last updated
Nov 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.