search
Back to results

Probiotic Sport Study

Primary Purpose

Oxidative Stress, Inflammation, Endotoxemia

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
probiotic-based dietary supplement
placebo
Sponsored by
Green Beat
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Oxidative Stress focused on measuring oxidative stress, inflammation, endotoxemia, strenuous exercise

Eligibility Criteria

30 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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"

Sites / Locations

  • Medical University of Graz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

probiotic-based dietary supplement

placebo

Arm Description

Outcomes

Primary Outcome Measures

markers of oxidative stress, endotoxemia and inflammation

Secondary Outcome Measures

Full Information

First Posted
November 16, 2011
Last Updated
April 9, 2013
Sponsor
Green Beat
search

1. Study Identification

Unique Protocol Identification Number
NCT01474629
Brief Title
Probiotic Sport Study
Official Title
Impact of Supplementation With Probiotics on Exercise-induced Oxidative Stress and Endotoxemia in Trained Men
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Green Beat

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress, Inflammation, Endotoxemia
Keywords
oxidative stress, inflammation, endotoxemia, strenuous exercise

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
probiotic-based dietary supplement
Arm Type
Active Comparator
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotic-based dietary supplement
Other Intervention Name(s)
active group
Intervention Description
24 trained men receive a probiotic-based dietary supplement for 16 weeks. Dosage 3x 10-9 per day
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Other Intervention Name(s)
passive group
Intervention Description
24 trained men receive a placebo for 16 weeks with same dosage compared to active group
Primary Outcome Measure Information:
Title
markers of oxidative stress, endotoxemia and inflammation
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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"
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manfred Lamprecht, PhD PhD
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
ZIP/Postal Code
8010
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
22992437
Citation
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.
Results Reference
derived

Learn more about this trial

Probiotic Sport Study

We'll reach out to this number within 24 hrs