Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05350176 |
Other study ID # |
Lact.Bas |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 10, 2023 |
Est. completion date |
December 20, 2023 |
Study information
Verified date |
January 2024 |
Source |
University of the Basque Country (UPV/EHU) |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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. 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.
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.