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

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

      • Beersheva, Israel
        • IDF

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.
Experimental: HMB-FA
Active treatment consisting of 3 g of HMB-FA per day.
Other Names:
  • beta-hydroxy-beta-methylbutyric acid

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
Muscle morphology will be measured using a 3.0 Tesla Magnetic Resonance Imaging device.
Day 18
Muscle Mass
Time Frame: Day 18
Muscle mass will be performed using bioelectrical impedance
Day 18
Blood Biochemical Analysis
Time Frame: Day 18
Blood biochemical analysis will be performed using an ELISA assay.
Day 18
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.

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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