NCT02503007

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 25, 2015

Status Verified

October 1, 2015

Enrollment Period

2 months

First QC Date

July 15, 2015

Last Update Submit

November 24, 2015

Conditions

Survival Training

Outcome Measures

Primary Outcomes (1)

  • Muscle Strength

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

    Day 18

Secondary Outcomes (5)

  • Muscle Power

    Day 18

  • Muscle Morphology

    Day 18

  • Muscle Mass

    Day 18

  • Blood Biochemical Analysis

    Day 18

  • Urine Biochemical Analysis

    Day 18

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

HMB-FA

EXPERIMENTAL

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

Dietary Supplement: HMB-FA

Interventions

PlaceboDIETARY_SUPPLEMENT
Placebo
HMB-FADIETARY_SUPPLEMENT
Also known as: beta-hydroxy-beta-methylbutyric acid
HMB-FA

Eligibility Criteria

Age18 Years - 27 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IDF

Beersheva, Israel

Location

Study Officials

  • Ishay Osterfeld, MD

    International Diabetes Federation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2015

First Posted

July 20, 2015

Study Start

July 1, 2015

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

November 25, 2015

Record last verified: 2015-10

Locations

IL(1)