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ProbioticsPhase 2PRO001NCT02520583

The Effects of Probiotic Supplementation on Markers of Muscle Damage and Performance Following Exercise Induced Muscle Damage

A Phase 2 study testing Lactic acid bacteria and bifidobacteria in people with Probiotics, run by Texas Christian University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To determine the effect of probiotic supplementation on the inflammatory response and subsequent performance following a muscle damaging exercise bout, a double-blind, randomized placebo controlled two-factor repeated measures design will be employed. Read more about this study

Who is it for?
Ages 18 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for
Probiotics
What is being tested?
Lactic acid bacteria and bifidobacteria
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
1 siteUnited States
Study dates
Feb 2015to Aug 2015
Phase
Phase 2
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 35 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants must currently be participating in structured resistance training and must have been doing so for the previous 1 year period.

Who cannot join

  • Having consumed any nutritional supplements and/or ergogenic aids for the preceding 6 week period.
  • Having not taken any anti-inflammatory medications for the previous month.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Texas Christian Universti

    Fort Worth, Texas, 76129

Other trials in United States

About this study

To determine the effect of probiotic supplementation on the inflammatory response and subsequent performance following a muscle damaging exercise bout, a double-blind, randomized placebo controlled two-factor repeated measures design will be employed. The dependent variables for this study will include measures of performance as well as markers of inflammation in a single limb model. Participants who qualify for study participation will have their height, weight, and body composition assessed (skin fold) followed by baseline measurements for determination of isometric and dynamic strength. Initial limb will be determined randomly. Following baseline testing, participants will randomly be assigned to ingest either a probiotic or placebo. Supplementation will begin at least 24 hours post baseline testing. Twenty-one days after initiating supplementation, participants will again complete performance testing followed by an exercise bout known to elicit muscle damage and produce an inflammatory response. Participants will then repeat performance testing 24, 48, and 72 hours post muscle damaging bout. Blood samples for determination of markers of inflammation will be taken throughout study duration. Following a 3-week wash-out period (21 days), participants will repeat the experiment following the alternate supplement regimen with the contralateral limb.

Read the detailed description

General Performance Testing and Muscle Damaging Exercise Bout Following familiarization and consenting procedures, participants will complete a series of performance tests designed to determine maximal performance. Those tests will include a test of isometric strength and dynamic strength of the elbow flexors. Isometric strength will be tested with subjects elbow at a fixed angle and measurement of the force the subject exerts, while dynamic strength with be a test of maximal strength through a specified range of motion. Prior to baseline testing, participants will be asked to refrain from any physical activity outside of daily living for the preceding 48 hours as well as eliminate products that contain caffeine and/or alcohol. These tests will be repeated over the course of the study as outlined in Table 1 to examine if supplementation with probiotics attenuates the loss in strength following the muscle damaging exercise bout. An exercise bout known to induce significant muscle damage (eccentric) of the elbow flexors will be performed on Day 22 of supplementation. This will be an eccentric based protocol in which the muscle is stretched while generating force to overcome the stretch. To avoid any carryover effect, the initial arm will be selected at random while the contralateral arm will be used during the crossover experimental trial.

Nutrition and Supplementation Following baseline performance measures, participants will be randomly assigned to ingest, in a double blind manner, either a probiotic supplement or placebo. Participants will begin supplementation 24 hours post baseline performance measures and will ingest the supplement (capsule form) once per day prior to consuming any food. Supplementation will continue for 25 days (21 days prior to post measures and 4 days of post testing). To ensure compliance, participants will report to the laboratory weekly and be provided individually wrapped supplement containers. Return of empty containers will be used to verify compliance. In addition, participants will complete a daily supplement adherence and adverse side effects questionnaire (Appendix) weekly upon reporting to the laboratory.

Blood Sampling and Inflammatory Markers A baseline blood sample will be obtained prior to any performance testing and supplementation. Further, on the day of the muscle damaging exercise bout, participants will provide a blood sample for baseline determination of inflammatory blood markers and muscle damage. Blood samples will also be taken immediately post, 30, and 60 minutes post damaging exercise bout. Participants will then return to the laboratory 24, 48, and 72 hours following exercise bout to provide additional blood samples. Thirty six milliliters will be sampled at each time blood is drawn. If an emergency were to arise, the laboratory protocol for emergency management will be followed.

Soreness and Swelling Assessment An algometer will assess deep muscle pain and trigger point tenderness of the biceps muscles resulting from muscle damage. The investigators will apply a pressure algometer at points on the muscle. The pressure threshold measurements will consist of the following steps. First, the following explanation will be given to each participant: 'I am going to measure pressure threshold; that is, how much pressure will induce discomfort. I am going to increase pressure slowly with this device. Say ''Yes'' when you start to feel pain or discomfort. I will stop the pressure as soon as you say ''Yes'', so it will not hurt you. It is important that you understand that this is a test of sensitivity, not a test of endurance. Do you understand or have any questions?' After the explanation is given, the algometer will be placed exactly over the indelible mark and perpendicular to the muscle under observation. Pressure will increase continuously at 1 kg per second until the participant says 'Yes'. At this time, the pressure will stop, the meter removed from the skin, and the measurement recorded. The mean of 1 measurement taken at each of the 3 sites will be recorded as the pressure pain threshold. The subjects will be blinded to their pressure pain measurements. Additionally, the resting angle of the arm will be measured along with arm circumference to determine degree of swelling.

Conditions
Probiotics
Being tested
Lactic acid bacteria and bifidobacteria, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lactic acid bacteria and bifidobacteriaDietary supplement

  • PlaceboOther

Study groups in NCT02520583
Study groupRoleWhat they receive
MICROBACExperimentalBacterial cultures
Receives: Dietary Supplement: Lactic acid bacteria and bifidobacteria
PlaceboPlacebo comparatorMaltodextrin
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood markers of muscle damage (cytokines, creatine kinase)

    Measured: 1 year

Secondary outcomes (1)
  1. Isometric strength

    Isometric strength will be assessed on a isokinetic dynamometer

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

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 2
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02520583
Sponsor's protocol ID
1509-009-1502
Acronym
PRO001
Status last verified
Oct 2016
First submitted
29 Jul 2015
Last updated
19 Oct 2016
Results posted
No

Publications

  • Jager R, Purpura M, Stone JD, Turner SM, Anzalone AJ, Eimerbrink MJ, Pane M, Amoruso A, Rowlands DS, Oliver JM. Probiotic Streptococcus thermophilus FP4 and Bifidobacterium breve BR03 Supplementation Attenuates Performance and Range-of-Motion Decrements Following Muscle Damaging Exercise. Nutrients. 2016 Oct 14;8(10):642. doi: 10.3390/nu8100642.

    PubMed 27754427

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lactic acid bacteria and bifidobacteria in people with Probiotics, run by Texas Christian University at 1 site in United States.

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 1 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 19 Oct 2016. 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 United States. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Blood markers of muscle damage (cytokines, creatine kinase) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02520583, which also lists 1 linked publication.

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 19 Oct 2016.

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