Military TrainingNCT02762968
The Effects of Probiotic and HMB Supplementation on Immune and Digestive Function in Special Operations Soldiers
A study testing HMB and BC30 in people with Military Training, run by Metabolic Technologies Inc. at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Military Training
- What is being tested?
- HMB and BC30
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2016to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 years of age
- Member of the same unit of the IDF
Who cannot join
- Current use of dietary supplements
- Current chronic use of medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Military Training
- Being tested
- Placebo, HMB, BC30
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Placebo capsules similar to the experimental treatments.
HMBDietary supplement
Capsules containing calcium HMB.
BC30Dietary supplement
Bacillus Coagulans GBI-30, 6086 (BC30) mixed in water.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo capsules similar to the experimental treatments. Receives: Dietary Supplement: Placebo |
| HMB | Experimental | HMB capsules providing 3 g of calcium HMB per day. Receives: Dietary Supplement: HMB |
| HMB + BC30 | Experimental | Capsules providing 3 g calcium HMB per day plus Bacillus Coagulans GBI-30, 6086 (BC30) mixed in water. Receives: Dietary Supplement: HMB; Dietary Supplement: BC30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance of Immune function
Immune function assessed by blood biochemical analysis (ELISA).
Measured: 8 weeks
Secondary outcomes (2)
Maintenance of Digestive Function
Digestive function assessed by questionnaire.
Measured: 8 Weeks
Maintenance of Muscle Volume
Muscle volume will be assessed using a 3.0 Tesla whole-body imager (cubic centimeter)
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Military TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metabolic Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Central Florida
- Responsible party
- Sponsor
- Investigators
- Jay R Hoffman, PhD, Study director, University of Cenral Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762968
- Sponsor's protocol ID
- MTI2016-CS02
- Status last verified
- Jan 2017
- First submitted
- 3 May 2016
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of 8-weeks of Probiotic and HMB Supplementation on Immune and Digestive Function in Special Operations Soldiers
- ClinicalTrials.gov ID
- NCT02762968
- Acronym / sponsor ID
- MTI2016-CS02
- Conditions
- Military Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Metabolic Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Central Florida
- Study start
- Apr 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsules similar to the experimental treatments. |
| HMB | Experimental | Dietary Supplement: HMBHMB capsules providing 3 g of calcium HMB per day. |
| HMB + BC30 | Experimental | Dietary Supplement: HMB, Dietary Supplement: BC30Capsules providing 3 g calcium HMB per day plus Bacillus Coagulans GBI-30, 6086 (BC30) mixed in water. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18 years of age
- Member of the same unit of the IDF
Key exclusion criteria (2 listed)
- Current use of dietary supplements
- Current chronic use of medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo capsules similar to the experimental treatments. | Dietary supplement | Placebo |
| HMBCapsules containing calcium HMB. | Dietary supplement | HMB, HMB + BC30 |
| BC30Bacillus Coagulans GBI-30, 6086 (BC30) mixed in water. | Dietary supplement | HMB + BC30 |
Primary outcome
Maintenance of Immune function
Time frame: 8 weeks
Immune function assessed by blood biochemical analysis (ELISA).
2 secondary outcomes
Maintenance of Digestive Function
Time frame: 8 Weeks
Maintenance of Muscle Volume
Time frame: 8 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay R Hoffman, PhD study director
University of Cenral Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HMB and BC30 in people with Military Training, run by Metabolic Technologies Inc. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintenance of Immune function (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017.