Probiotic Sport Study
Impact of Supplementation With Probiotics on Exercise-induced Oxidative Stress and Endotoxemia in Trained Men
1 other identifier
interventional
24
1 country
1
Brief Summary
We investigate the impact of a probiotic-based dietary supplement on oxidative stress and endotoxemia before and after strenuous exercise. Hypotheses (H1):
- Supplementation has an influence on oxidative stress parameters before and post exercise
- Supplementation has an influence on parameters of endotoxemia and inflammation before and post exercise
- Strenuous exercise has an influence on parameters of oxidative stress, inflammation and endotoxemia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 16, 2011
CompletedFirst Posted
Study publicly available on registry
November 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedApril 10, 2013
April 1, 2013
5 months
November 16, 2011
April 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
markers of oxidative stress, endotoxemia and inflammation
6 months
Study Arms (2)
probiotic-based dietary supplement
ACTIVE COMPARATORplacebo
PLACEBO COMPARATORInterventions
24 trained men receive a probiotic-based dietary supplement for 16 weeks. Dosage 3x 10-9 per day
24 trained men receive a placebo for 16 weeks with same dosage compared to active group
Eligibility Criteria
You may qualify if:
- trained men
- years
- non-smokers
- wk wash out of all dietary supplements
You may not qualify if:
- untrained people (VO2max \< 55 ml x kg-1)
- female
- all people not matching this age group
- smokers
- all men taking dietary supplements
- all men that fail in ergometric exercise eligibility testing, refering to the standards in sports medicine (e.g.: significant ST-decrease or increase, blood pressure \> 240 mmHg, tachycardia, polymorphic extrasystolia, cyanosis, bradyarrhythmia..)
- all people that are not adjudged as "Healthy"
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Green Beatlead
Study Sites (1)
Medical University of Graz
Graz, 8010, Austria
Related Publications (1)
Lamprecht M, Bogner S, Schippinger G, Steinbauer K, Fankhauser F, Hallstroem S, Schuetz B, Greilberger JF. Probiotic supplementation affects markers of intestinal barrier, oxidation, and inflammation in trained men; a randomized, double-blinded, placebo-controlled trial. J Int Soc Sports Nutr. 2012 Sep 20;9(1):45. doi: 10.1186/1550-2783-9-45.
PMID: 22992437DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manfred Lamprecht, PhD PhD
Medical University of Graz
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
November 16, 2011
First Posted
November 18, 2011
Study Start
October 1, 2011
Primary Completion
March 1, 2012
Study Completion
September 1, 2012
Last Updated
April 10, 2013
Record last verified: 2013-04