The Effects of Probiotic Supplementation on Markers of Muscle Damage and Performance Following Exercise Induced Muscle Damage (PRO001)

October 18, 2016 updated by: Jonathan Oliver, Texas Christian University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76129
        • Texas Christian Universti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Maltodextrin
Other: Placebo
Experimental: MICROBAC
Bacterial cultures
Dietary supplement: Lactic acid bacteria and bifidobacteria

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Blood markers of muscle damage (cytokines, creatine kinase)
Time Frame: 1 year
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Isometric strength
Time Frame: 1 year
Isometric strength will be assessed on a isokinetic dynamometer
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas Christian University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 13, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1509-009-1502

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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