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

NCT02520583 | Completed Phase 2

• 1 other identifier: 1509-009-1502
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Probiotics

Outcome Measures

Primary Outcomes (1)

• Blood markers of muscle damage (cytokines, creatine kinase)

  1 year

Secondary Outcomes (1)

• Isometric strength

  1 year

Study Arms (2)

MICROBAC

EXPERIMENTAL

Bacterial cultures

Dietary Supplement: Lactic acid bacteria and bifidobacteria

Placebo

PLACEBO COMPARATOR

Maltodextrin

Other: Placebo

Interventions

Lactic acid bacteria and bifidobacteria DIETARY_SUPPLEMENT

MICROBAC

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Christian University: lead

Study Sites (1)

Texas Christian Universti

Fort Worth, Texas, 76129, United States

Location

Related Publications (1)

• 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.

  PMID: 27754427 DERIVED

MeSH Terms

Interventions

Lacteol

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: August 13, 2015
• Study Start: February 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 19, 2016

Record last verified: 2016-10

Locations

US (1)