Probiotic Sport Study

Sponsor

Green Beat (Other)

Overall Status

Completed

CT.gov ID

NCT01474629

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Oxidative Stress Inflammation Endotoxemia	Dietary Supplement: probiotic-based dietary supplement Dietary Supplement: placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: passive group

Arm

Intervention/Treatment

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 Names:

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 Names:

passive group

Outcome Measures

Primary Outcome Measures

markers of oxidative stress, endotoxemia and inflammation [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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"