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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014