Probiotic Sport Study

NCT ID: NCT01474629

Last Updated: 2013-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oxidative Stress Inflammation Endotoxemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

probiotic-based dietary supplement

Group Type ACTIVE_COMPARATOR

probiotic-based dietary supplement

Intervention Type DIETARY_SUPPLEMENT

24 trained men receive a probiotic-based dietary supplement for 16 weeks. Dosage 3x 10-9 per day

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

24 trained men receive a placebo for 16 weeks with same dosage compared to active group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

probiotic-based dietary supplement

24 trained men receive a probiotic-based dietary supplement for 16 weeks. Dosage 3x 10-9 per day

Intervention Type DIETARY_SUPPLEMENT

placebo

24 trained men receive a placebo for 16 weeks with same dosage compared to active group

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

active group passive group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* trained men
* 30 - 45 years
* non-smokers
* 4wk wash out of all dietary supplements

Exclusion Criteria

* 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"
Minimum Eligible Age

30 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Green Beat

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lamprecht Manfred PhD, PhD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Manfred Lamprecht, PhD PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University of Graz

Graz, , Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 22992437 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

23-509 ex 10/11

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ribose and Sport Performance
NCT01727479 COMPLETED NA