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

NCT ID: NCT02762968

Last Updated: 2017-01-30

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Military Training

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Placebo capsules similar to the experimental treatments.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo capsules similar to the experimental treatments.

HMB

HMB capsules providing 3 g of calcium HMB per day.

Group Type EXPERIMENTAL

HMB

Intervention Type DIETARY_SUPPLEMENT

Capsules containing calcium HMB.

HMB + BC30

Capsules providing 3 g calcium HMB per day plus Bacillus Coagulans GBI-30, 6086 (BC30) mixed in water.

Group Type EXPERIMENTAL

HMB

Intervention Type DIETARY_SUPPLEMENT

Capsules containing calcium HMB.

BC30

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

Placebo capsules similar to the experimental treatments.

Intervention Type DIETARY_SUPPLEMENT

HMB

Capsules containing calcium HMB.

Intervention Type DIETARY_SUPPLEMENT

BC30

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Central Florida

OTHER

Sponsor Role collaborator

Metabolic Technologies Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jay R Hoffman, PhD

Role: STUDY_DIRECTOR

University of Cenral Florida

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Israel

Beersheva, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MTI2016-CS02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Probiotics and Gut Health
NCT03418857 RECRUITING PHASE1/PHASE2