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

NCT ID: NCT02503007

Last Updated: 2015-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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

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Survival Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

A placebo similar in composition and appearance to the experimental treatment.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

HMB-FA

Active treatment consisting of 3 g of HMB-FA per day.

Group Type EXPERIMENTAL

HMB-FA

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Placebo

Intervention Type DIETARY_SUPPLEMENT

HMB-FA

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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beta-hydroxy-beta-methylbutyric acid

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

27 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Koach Sport and Nutrition

UNKNOWN

Sponsor Role collaborator

Metabolic Technologies Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ishay Osterfeld, MD

Role: PRINCIPAL_INVESTIGATOR

International Diabetes Federation

Locations

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IDF

Beersheva, , Israel

Site Status

Countries

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Israel

Other Identifiers

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MTI2015-CS01

Identifier Type: -

Identifier Source: org_study_id