Probiotic Sport Study

Inflammation Clinical Trial

Official title:

Impact of Supplementation With Probiotics on Exercise-induced Oxidative Stress and Endotoxemia in Trained Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01474629
• Other study ID #: 23-509 ex 10/11
• Status: Completed
• Phase: N/A
• First received: November 16, 2011
• Last updated: April 9, 2013
• Start date: October 2011
• Est. completion date: September 2012

Study information

• Verified date: April 2013
• Source: Green Beat
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Endotoxemia
• Inflammation
• Oxidative Stress

Intervention

Dietary Supplement:
• probiotic-based dietary supplement
24 trained men receive a probiotic-based dietary supplement for 16 weeks. Dosage 3x 10-9 per day
• placebo
24 trained men receive a placebo for 16 weeks with same dosage compared to active group

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Green Beat

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	markers of oxidative stress, endotoxemia and inflammation		6 months	No