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

January 27, 2017 updated by: Metabolic Technologies Inc.

The Effects of 8-weeks 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beersheva, Israel
        • Israel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Placebo capsules similar to the experimental treatments.
Dietary supplement: Placebo
Placebo capsules similar to the experimental treatments.
EXPERIMENTAL: HMB
HMB capsules providing 3 g of calcium HMB per day.
Dietary supplement: HMB
Capsules containing calcium HMB.
EXPERIMENTAL: HMB + BC30
Capsules providing 3 g calcium HMB per day plus Bacillus Coagulans GBI-30, 6086 (BC30) mixed in water.
Dietary supplement: HMB
Capsules containing calcium HMB.
Dietary supplement: BC30
Bacillus Coagulans GBI-30, 6086 (BC30) mixed in water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maintenance of Immune function
Time Frame: 8 weeks
Immune function assessed by blood biochemical analysis (ELISA).
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maintenance of Digestive Function
Time Frame: 8 Weeks
Digestive function assessed by questionnaire.
8 Weeks
Maintenance of Muscle Volume
Time Frame: 8 Weeks
Muscle volume will be assessed using a 3.0 Tesla whole-body imager (cubic centimeter)
8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Metabolic Technologies Inc.

Collaborators

University of Central Florida

Investigators

  • Study Director: Jay R Hoffman, PhD, University of Cenral Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (ESTIMATE)

May 5, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

January 30, 2017

Last Update Submitted That Met QC Criteria

January 27, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • MTI2016-CS02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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