Survival TrainingNCT02503007

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

A study testing HMB-FA in people with Survival Training, run by Metabolic Technologies Inc. at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 27 yearsHealthy volunteers can take part
Conditions the study is for: Survival Training
What is being tested?: HMB-FA
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 1 siteIsrael
Study dates: Jul 2015to Oct 2015
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 27 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Israel1 site

IDF
Beersheva

Other trials in Israel

About this study

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

Read the 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.

Conditions: Survival Training
Being tested: Placebo, HMB-FA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDietary supplement
HMB-FADietary supplement
Also called beta-hydroxy-beta-methylbutyric acid

Study groups in NCT02503007
Study group	Role	What they receive
Placebo	Placebo comparator	A placebo similar in composition and appearance to the experimental treatment. Receives: Dietary Supplement: Placebo
HMB-FA	Experimental	Active treatment consisting of 3 g of HMB-FA per day. Receives: Dietary Supplement: HMB-FA

What is being measured

The primary outcome is the main question the study is designed to answer.

Muscle Strength
Hand grip strength will be measured using a hand-grip dynamometer.
Measured: Day 18

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2015Oct 2015

First posted20 Jul 2015 (estimated)
Study startJul 2015
Primary completionSep 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Survival TrainingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02503007
Sponsor's protocol ID: MTI2015-CS01
Status last verified: Oct 2015
First submitted: 15 Jul 2015
Last updated: 25 Nov 2015
Results posted: No
Data monitoring committee: No