- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01474629
Probiotic Sport Study
April 9, 2013 updated by: Lamprecht Manfred PhD, PhD, Green Beat
Impact of Supplementation With Probiotics on Exercise-induced Oxidative Stress and Endotoxemia in Trained Men
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
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
-
-
-
Graz, Austria, 8010
- Medical University of Graz
-
-
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
Ages Eligible for Study
30 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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"
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
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
|
24 trained men receive a placebo for 16 weeks with same dosage compared to active group
Other Names:
|
Active Comparator: probiotic-based dietary supplement
|
24 trained men receive a probiotic-based dietary supplement for 16 weeks.
Dosage 3x 10-9 per day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
markers of oxidative stress, endotoxemia and inflammation
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
October 1, 2011
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
November 16, 2011
First Submitted That Met QC Criteria
November 17, 2011
First Posted (Estimate)
November 18, 2011
Study Record Updates
Last Update Posted (Estimate)
April 10, 2013
Last Update Submitted That Met QC Criteria
April 9, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-509 ex 10/11
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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