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Probiotic Sport Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lamprecht Manfred PhD, PhD, Green Beat
ClinicalTrials.gov Identifier:
NCT01474629
First received: November 16, 2011
Last updated: April 9, 2013
Last verified: April 2013
History of Changes

November 16, 2011
April 9, 2013
October 2011
March 2012   (final data collection date for primary outcome measure)
markers of oxidative stress, endotoxemia and inflammation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01474629 on ClinicalTrials.gov Archive Site
Not Provided
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Probiotic Sport Study
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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
  • Oxidative Stress
  • Inflammation
  • Endotoxemia
  • Dietary Supplement: probiotic-based dietary supplement
    24 trained men receive a probiotic-based dietary supplement for 16 weeks. Dosage 3x 10-9 per day
    Other Name: active group
  • Dietary Supplement: placebo
    24 trained men receive a placebo for 16 weeks with same dosage compared to active group
    Other Name: passive group
  • Active Comparator: probiotic-based dietary supplement
    Intervention: Dietary Supplement: probiotic-based dietary supplement
  • Placebo Comparator: placebo
    Intervention: Dietary Supplement: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
September 2012
March 2012   (final data collection date for primary outcome measure)

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"
Male
30 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01474629
23-509 ex 10/11
Yes
Lamprecht Manfred PhD, PhD, Green Beat
Green Beat
Not Provided
Principal Investigator: Manfred Lamprecht, PhD PhD Medical University of Graz
Green Beat
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP