Sport PerformanceNCT05350176
Probiotic Supplementation in Sport Performance and Gut Damage
A study testing Probiotic in people with Sport Performance and Gut Damage, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
Trial summary
This study will be performed with the aim to evaluate the effects of probiotic supplementation on sport performance and gut damage. Participants will be divided into two groups, placebo and experimental group. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sport Performance, Gut Damage
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 10 Oct 2023to 20 Dec 2023
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- No injuries
- 1 year of CrossFit practicing experience
Who cannot join
- Drug, alcohol, cigarettes, probiotic intake
- Injuries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Probiotic Supplementation on Sport Performance and Gut Damage in CrossFit
This study will be performed with the aim to evaluate the effects of probiotic supplementation on sport performance and gut damage. Participants will be divided into two groups, placebo and experimental group. With the purpose to assess the effects of probiotics on the gut damage, a strenuous exercise session will be performed, and then blood samples will be taken to observe the variation of the selected intestinal damage marker. 24 hours after this strenuous session, performance tests will be performed. After the 4 weeks of supplementation, the same procedure will be followed to evaluate the effect of probiotics.
Read the detailed description
One week before the initiation of the study participants will be required to avoid consuming drugs, alcohol, cigarettes, probiotics, and any other food or liquid which could modify gut microbiota composition. For the baseline values, height, weight and sports performance test, of the participants will be collected. The same day, a strenuous exercise session will be performed in order to observe the variation of the intestinal damage marker (blood sample extraction just after finishing the strenous exercise session). 24 hours after that session sport performance tests will be conducted. Participants will then be randomly divided into two groups, one of which will take one probiotic capsule per day containing 10 billion colony-forming units (CFU) of Lactobacillus plantarum, and the other group will take one placebo capsule per day consisting of dextrose. The supplementation period will last 4 weeks.
After the supplementation period, the same process will be followed, with the same strenuous exercise session and immediate blood sampling to determine the effects of probiotics on the intestinal damage caused by exercise. 24 hours later, performance tests will be conducted to assess the effects of probiotics on sport performance.
- Conditions
- Sport Performance, Gut Damage
- Being tested
- Probiotic, Placebo
- Keywords
- Probiotic, Gut damage, Sport performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Probiotic capsules will be composed of 10 billion CFU of Lactobacillus plantarum.
PlaceboDietary supplement
Capsules containing dextrose (1 capsule per day)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Probiotic intake containing 10 billions of Colony Forming Units of Lactobacillus plantarum (1 capsule per day) Receives: Dietary Supplement: Probiotic |
| Placebo group | Placebo comparator | Placebo intake. Placebo capsules will contain dextrose (1 capsule per day) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal-fatty acid-binding protein
Gut damage marker
Measured: 0-10 minutes after strenuous exercise blood samples will be extracted
Counter movement jump test
Jumping test
Measured: 24 hours after strenuous training session. First test to be performed
Running Based Anaerobic Sprint Test
Running test
Measured: 24 hours after strenuous training session. Second test to be performed
YO YO Intermittent Recovery Level test 1
aerobic test
Measured: 24 hours after strenuous training session. Third test to be performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start10 Oct 2023
- Primary completion20 Nov 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sport PerformanceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Basque Country (UPV/EHU)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asier Santibañez, University of the Basque Country (UPV/EHU)
- Investigators
- Asier Santibañez, MsC, Principal investigator, University of the Basque Country (UPV/EHU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350176
- Sponsor's protocol ID
- Lact.Bas
- Status last verified
- Jan 2024
- First submitted
- 22 Apr 2022
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotic Supplementation on Sport Performance and Gut Damage in CrossFit
- ClinicalTrials.gov ID
- NCT05350176
- Acronym / sponsor ID
- Lact.Bas
- Conditions
- Sport Performance, Gut Damage
- Keywords
- Probiotic, Gut damage, Sport performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of the Basque Country (UPV/EHU)University, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 28 Apr 2022 (actual)
- 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.
This study will be performed with the aim to evaluate the effects of probiotic supplementation on sport performance and gut damage. Participants will be divided into two groups, placebo and experimental group. With the purpose to assess the effects of probiotics on the gut damage, a strenuous exercise session will be performed, and then blood samples will be taken to observe the variation of the selected intestinal damage marker. 24 hours after this strenuous session, performance tests will be performed. After the 4 weeks of supplementation, the same procedure will be followed to evaluate the effect of probiotics.
Detailed description
One week before the initiation of the study participants will be required to avoid consuming drugs, alcohol, cigarettes, probiotics, and any other food or liquid which could modify gut microbiota composition. For the baseline values, height, weight and sports performance test, of the participants will be collected. The same day, a strenuous exercise session will be performed in order to observe the variation of the intestinal damage marker (blood sample extraction just after finishing the strenous exercise session). 24 hours after that session sport performance tests will be conducted. Participants will then be randomly divided into two groups, one of which will take one probiotic capsule per day containing 10 billion colony-forming units (CFU) of Lactobacillus plantarum, and the other group will take one placebo capsule per day consisting of dextrose. The supplementation period will last 4 weeks.
After the supplementation period, the same process will be followed, with the same strenuous exercise session and immediate blood sampling to determine the effects of probiotics on the intestinal damage caused by exercise. 24 hours later, performance tests will be conducted to assess the effects of probiotics on sport performance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Dietary Supplement: ProbioticProbiotic intake containing 10 billions of Colony Forming Units of Lactobacillus plantarum (1 capsule per day) |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboPlacebo intake. Placebo capsules will contain dextrose (1 capsule per day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy
- No injuries
- 1 year of CrossFit practicing experience
Key exclusion criteria (2 listed)
- Drug, alcohol, cigarettes, probiotic intake
- Injuries
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 |
|---|---|---|
| ProbioticProbiotic capsules will be composed of 10 billion CFU of Lactobacillus plantarum. | Dietary supplement | Experimental group |
| PlaceboCapsules containing dextrose (1 capsule per day) | Dietary supplement | Placebo group |
Primary outcome
Intestinal-fatty acid-binding protein
Time frame: 0-10 minutes after strenuous exercise blood samples will be extracted
Gut damage marker
Counter movement jump test
Time frame: 24 hours after strenuous training session. First test to be performed
Jumping test
Running Based Anaerobic Sprint Test
Time frame: 24 hours after strenuous training session. Second test to be performed
Running test
YO YO Intermittent Recovery Level test 1
Time frame: 24 hours after strenuous training session. Third test to be performed
aerobic test
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 24 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Asier Santibañez, MsC principal investigator
University of the Basque Country (UPV/EHU)
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 in people with Sport Performance and Gut Damage, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
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 3 inclusion and 2 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 24 Jan 2024. 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 Spain. 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?
Intestinal-fatty acid-binding protein (time frame: 0-10 minutes after strenuous exercise blood samples will be extracted). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2024.