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

Survival Training Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02503007
• Other study ID #: MTI2015-CS01
• Status: Completed
• Phase: N/A
• First received: July 15, 2015
• Last updated: November 24, 2015
• Start date: July 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Metabolic Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 27 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Survival Training

Intervention

Dietary Supplement:
• Placebo

• HMB-FA

Locations

Country	Name	City	State
Israel	IDF	Beersheva

Sponsors (2)

Lead Sponsor	Collaborator
Metabolic Technologies Inc.	Koach Sport and Nutrition

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle Strength	Hand grip strength will be measured using a hand-grip dynamometer.	Day 18	No
Secondary	Muscle Power	Vertical Jump power will be measured using a linear transducer.	Day 18	No
Secondary	Muscle Morphology	Muscle morphology will be measured using a 3.0 Tesla Magnetic Resonance Imaging device.	Day 18	No
Secondary	Muscle Mass	Muscle mass will be performed using bioelectrical impedance	Day 18	No
Secondary	Blood Biochemical Analysis	Blood biochemical analysis will be performed using an ELISA assay.	Day 18	No
Secondary	Urine Biochemical Analysis	Urine biochemical analysis will be performed using an ELISA assay.	Day 18	No