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

Military Training Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02762968
• Other study ID #: MTI2016-CS02
• Status: Completed
• Phase: N/A
• First received: May 3, 2016
• Last updated: January 27, 2017
• Start date: April 2016
• Est. completion date: August 2016

Study information

• Verified date: January 2017
• Source: Metabolic Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Military Training

Intervention

Dietary Supplement:
• Placebo
Placebo capsules similar to the experimental treatments.
• HMB
Capsules containing calcium HMB.
• BC30
Bacillus Coagulans GBI-30, 6086 (BC30) mixed in water.

Locations

Country	Name	City	State
Israel	Israel	Beersheva

Sponsors (2)

Lead Sponsor	Collaborator
Metabolic Technologies Inc.	University of Central Florida

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maintenance of Immune function	Immune function assessed by blood biochemical analysis (ELISA).	8 weeks
Secondary	Maintenance of Digestive Function	Digestive function assessed by questionnaire.	8 Weeks
Secondary	Maintenance of Muscle Volume	Muscle volume will be assessed using a 3.0 Tesla whole-body imager (cubic centimeter)	8 Weeks