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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
  Purpose

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

Condition Intervention
Oxidative Stress
Inflammation
Endotoxemia
 Dietary Supplement: probiotic-based dietary supplement
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Impact of Supplementation With Probiotics on Exercise-induced Oxidative Stress and Endotoxemia in Trained Men

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Green Beat:

Primary Outcome Measures:
  • markers of oxidative stress, endotoxemia and inflammation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: October 2011
Study Completion Date: September 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: probiotic-based dietary supplement 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
Placebo Comparator: placebo Dietary Supplement: placebo
24 trained men receive a placebo for 16 weeks with same dosage compared to active group
Other Name: passive group

  Eligibility

Ages Eligible for Study:   30 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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"
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474629

Locations
Austria
Medical University of Graz
Graz, Austria, 8010
Sponsors and Collaborators
Green Beat
Investigators
Principal Investigator: Manfred Lamprecht, PhD PhD Medical University of Graz
  More Information

No publications provided

Responsible Party: Lamprecht Manfred PhD, PhD, Principal investigator, Green Beat
ClinicalTrials.gov Identifier: NCT01474629     History of Changes
Other Study ID Numbers: 23-509 ex 10/11
Study First Received: November 16, 2011
Last Updated: April 9, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by Green Beat:
oxidative stress
inflammation
endotoxemia
strenuous exercise

Additional relevant MeSH terms:
Inflammation
Endotoxemia
Pathologic Processes
Bacteremia
 Sepsis
Infection
Toxemia
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on May 22, 2013