Probiotic Supplementation on Sport Performance and Gut Damage in Females
Effects of Probiotic Supplementation on Sport Performance and Gut Damage in Females CrossFit Athletes
1 other identifier
interventional
10
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2023
CompletedFirst Submitted
Initial submission to the registry
January 12, 2024
CompletedFirst Posted
Study publicly available on registry
January 23, 2024
CompletedJanuary 24, 2024
January 1, 2024
1 month
January 12, 2024
January 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Intestinal-fatty acid-binding protein
Gut damage marker
0-10 minutes after strenuous exercise blood samples will be extracted
Counter movement jump test
Jumping test
24 hours after strenuous training session. First test to be performed
Running Based Anaerobic Sprint Test
Running test
24 hours after strenuous training session. Second test to be performed
YO YO Intermittent Recovery Level test 1
aerobic test
24 hours after strenuous training session. Third test to be performed
Study Arms (2)
Experimental group
EXPERIMENTALProbiotic intake containing 10 billions of Colony Forming Units of Lactobacillus plantarum (1 capsule per day)
Placebo group
PLACEBO COMPARATORPlacebo intake. Placebo capsules will contain dextrose (1 capsule per day)
Interventions
Eligibility Criteria
You may qualify if:
- Healthy
- No injuries
- year of CrossFit practicing experience
You may not qualify if:
- Drug, alcohol, cigarettes, probiotic intake
- Injuries
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CrossFit Bikain
Vitoria-Gasteiz, Alava, 01015, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Asier Santibañez, MsC
University of the Basque Country (UPV/EHU)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
January 12, 2024
First Posted
January 23, 2024
Study Start
October 15, 2023
Primary Completion
November 15, 2023
Study Completion
December 15, 2023
Last Updated
January 24, 2024
Record last verified: 2024-01