NCT02762968

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

3 months

First QC Date

May 3, 2016

Last Update Submit

January 27, 2017

Conditions

Military Training

Outcome Measures

Primary Outcomes (1)

  • Maintenance of Immune function

    Immune function assessed by blood biochemical analysis (ELISA).

    8 weeks

Secondary Outcomes (2)

  • Maintenance of Digestive Function

    8 Weeks

  • Maintenance of Muscle Volume

    8 Weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo capsules similar to the experimental treatments.

Dietary Supplement: Placebo

HMB

EXPERIMENTAL

HMB capsules providing 3 g of calcium HMB per day.

Dietary Supplement: HMB

HMB + BC30

EXPERIMENTAL

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

Dietary Supplement: HMBDietary Supplement: BC30

Interventions

PlaceboDIETARY_SUPPLEMENT

Placebo capsules similar to the experimental treatments.

Placebo
HMBDIETARY_SUPPLEMENT

Capsules containing calcium HMB.

HMBHMB + BC30
BC30DIETARY_SUPPLEMENT

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

HMB + BC30

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Israel

Beersheva, Israel

Location

Study Officials

  • Jay R Hoffman, PhD

    University of Cenral Florida

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 5, 2016

Study Start

April 1, 2016

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

January 30, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)