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NCT02520583 · ClinicalTrials.gov registry record · Phase 2
The Effects of Probiotic Supplementation on Markers of Muscle Damage and Performance Following Exercise Induced Muscle Damage
A Phase 2 study of Probiotics, sponsored by Texas Christian University.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT02520583 is a Phase 2 study of Probiotics that has completed, run by Texas Christian University. The registered enrollment target is 15 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02520583, a Phase 2 study of Probiotics, has completed, sponsored by Texas Christian University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Conditions Studied
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Lactic acid bacteria and bifidobacteria
Study Locations (1)
Texas
- Texas Christian Universti - Fort Worth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2015-02 |
| Est. Completion | 2015-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02520583
The ClinicalTrials.gov registry entry for NCT02520583 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Texas Christian University, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Probiotics appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02520583 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT02520583 about?
NCT02520583 is a clinical study titled "The Effects of Probiotic Supplementation on Markers of Muscle Damage and Performance Following Exercise Induced Muscle Damage". 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 incl...
What is the current status of trial NCT02520583?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2015-02. Estimated completion is 2015-08.
What conditions does trial NCT02520583 study?
This clinical trial studies the following conditions: Probiotics.
What interventions are being tested in trial NCT02520583?
The interventions under investigation include: Placebo (OTHER), Lactic acid bacteria and bifidobacteria (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02520583?
This trial is sponsored by Texas Christian University, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02520583 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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