Oxidative StressNCT01474629
Probiotic Sport Study
A study testing probiotic-based dietary supplement in people with Oxidative Stress and Inflammation, run by Green Beat at 1 site in Austria.
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… Read more about this study
- Who is it for?
- Ages 30 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Inflammation, Endotoxemia
- What is being tested?
- probiotic-based dietary supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2011to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- trained men
- 30 - 45 years
- non-smokers
- 4wk wash out of all dietary supplements
Who cannot join
- 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"
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Oxidative Stress, Inflammation, Endotoxemia
- Being tested
- probiotic-based dietary supplement, placebo
- Keywords
- oxidative stress, inflammation, endotoxemia, strenuous exercise
- Medical subject headings
- Inflammation, Endotoxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic-based dietary supplementDietary supplement
Also called active group
24 trained men receive a probiotic-based dietary supplement for 16 weeks. Dosage 3x 10-9 per day
placeboDietary supplement
Also called passive group
24 trained men receive a placebo for 16 weeks with same dosage compared to active group
| Study group | Role | What they receive |
|---|---|---|
| probiotic-based dietary supplement | Active comparator | Not described Receives: Dietary Supplement: probiotic-based dietary supplement |
| placebo | Placebo comparator | Not described Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
markers of oxidative stress, endotoxemia and inflammation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionMar 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Beat
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamprecht Manfred PhD, PhD, Green Beat
- Investigators
- Manfred Lamprecht, PhD PhD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474629
- Sponsor's protocol ID
- 23-509 ex 10/11
- Status last verified
- Apr 2013
- First submitted
- 16 Nov 2011
- Last updated
- 10 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lamprecht M, Bogner S, Schippinger G, Steinbauer K, Fankhauser F, Hallstroem S, Schuetz B, Greilberger JF. Probiotic supplementation affects markers of intestinal barrier, oxidation, and inflammation in trained men; a randomized, double-blinded, placebo-controlled trial. J Int Soc Sports Nutr. 2012 Sep 20;9(1):45. doi: 10.1186/1550-2783-9-45.
PubMed 22992437
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Supplementation With Probiotics on Exercise-induced Oxidative Stress and Endotoxemia in Trained Men
- ClinicalTrials.gov ID
- NCT01474629
- Acronym / sponsor ID
- 23-509 ex 10/11
- Conditions
- Oxidative Stress, Inflammation, Endotoxemia
- Keywords
- oxidative stress, inflammation, endotoxemia, strenuous exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Green BeatUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 18 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotic-based dietary supplement | Active comparator | Dietary Supplement: probiotic-based dietary supplement |
| placebo | Placebo comparator | Dietary Supplement: placebo |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- trained men
- 30 - 45 years
- non-smokers
- 4wk wash out of all dietary supplements
Key exclusion criteria (7 listed)
- untrained people (VO2max < 55 ml x kg-1)
- female
- all people not matching this age group
- smokers
- all men taking dietary supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probiotic-based dietary supplementAlso: active group24 trained men receive a probiotic-based dietary supplement for 16 weeks. Dosage 3x 10-9 per day | Dietary supplement | probiotic-based dietary supplement |
| placeboAlso: passive group24 trained men receive a placebo for 16 weeks with same dosage compared to active group | Dietary supplement | placebo |
Primary outcome
markers of oxidative stress, endotoxemia and inflammation
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2013.
- Derived from this study: PubMed 22992437Lamprecht M, Bogner S, Schippinger G, Steinbauer K, Fankhauser F, Hallstroem S, Schuetz B, Greilberger JF. Probiotic supplementation affects markers of intestinal barrier, oxidation, and inflammation in trained men; a randomized, double-blinded, placebo-controlled trial. J Int Soc Sports Nutr. 2012 Sep 20;9(1):45. doi: 10.1186/1550-2783-9-45.
Related trials for Oxidative Stress
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Not yet recruiting
The Effects of Manual Acupuncture on Superoxide Dismutase Enzyme Activity and Questionnaire of Smoking Urges-Brief Scores in Active Smokers: A Randomized Controlled Trial
Superoxide Dismutase, Acupuncture
Not yet recruiting
Efficacy of MAGNESIO TOTAL on Sleep Quality and Quality of Life in Adults
Sleep Quality, Magnesium Deficiency
RecruitingPhase 2
Combination of NMDA-enhancing and Antioxidant Treatments for Schizophrenia
Schizophrenia
Recruiting
Acute Cryotherapy on Musculoskeletal Function and Biomarkers
Exercise Induced Muscle Damage, Cryotherapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred Lamprecht, PhD PhD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotic-based dietary supplement in people with Oxidative Stress and Inflammation, run by Green Beat at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
markers of oxidative stress, endotoxemia and inflammation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01474629, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2013.