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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Military Training

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: HMB
* Dietary Supplement: BC30


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo capsules similar to the experimental treatments. | Dietary Supplement: Placebo<br>* Placebo capsules similar to the experimental treatments.<br>|
| Experimental: HMB<br>HMB capsules providing 3 g of calcium HMB per day. | Dietary Supplement: HMB<br>* Capsules containing calcium HMB.<br>|
| Experimental: HMB + BC30<br>Capsules providing 3 g calcium HMB per day plus Bacillus Coagulans GBI-30, 6086 (BC30) mixed in water. | Dietary Supplement: HMB<br>* Capsules containing calcium HMB.<br>Dietary Supplement: BC30<br>* Bacillus Coagulans GBI-30, 6086 (BC30) mixed in water.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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