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Completed

NCT Number: NCT02762968

The Effects of Probiotic and HMB Supplementation on Immune and Digestive Function in Special Operations Soldiers

The study will determine whether acute ingestion of a probiotic combined with beta-hydroxy-beta-methylbutyrate (HMB) can enhance immune and digestive function in soldiers during 8-weeks of advanced infantry training.

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Key information

Conditions

Military Training

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Israel

Beersheva, Israel

About this study

Up to sixty soldiers from an elite infantry unit will perform a parallel design investigation. Soldiers will be randomly assigned to one of four groups. Group 1 will consume the probiotic plus HMB, group 2 will consume HMB only, group 3 will consume only the probiotic, and group 4 will consume only placebo. All four groups will be garrisoned together, eat the same meals, and perform the same activity. All groups will be tested before as well as after an 8-week advanced infantry training program. During each testing session resting blood samples will be obtained to assess cytokine, inflammatory, and muscle damage markers. Additionally, questionnaires will be used to determine digestive health. Anthropometric, performance, and muscle volume measures will also be assessed prior to and immediately following the supplementation and training protocol.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age
  • Member of the same unit of the IDF

Exclusion criteria

  • Current use of dietary supplements
  • Current chronic use of medications

Treatment and study plan

Placebo

Dietary Supplement

Placebo capsules similar to the experimental treatments.

HMB

Dietary Supplement

Capsules containing calcium HMB.

BC30

Dietary Supplement

Bacillus Coagulans GBI-30, 6086 (BC30) mixed in water.

Primary outcomes

  1. Maintenance of Immune function

    Time frame: 8 weeks

    Immune function assessed by blood biochemical analysis (ELISA).

Secondary outcomes

  1. Maintenance of Digestive Function

    Time frame: 8 Weeks

    Digestive function assessed by questionnaire.

  2. Maintenance of Muscle Volume

    Time frame: 8 Weeks

    Muscle volume will be assessed using a 3.0 Tesla whole-body imager (cubic centimeter)

Sponsors and collaborators

Lead sponsor

Metabolic Technologies Inc.

Industry

Collaborators

  • University of Central Florida

Registry information

Official study title

The Effects of 8-weeks of Probiotic and HMB Supplementation on Immune and Digestive Function in Special Operations Soldiers

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 5, 2016
Registry last updated
Jan 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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