Probiotic Supplementation on Sport Performance and Gut Damage in Females

Sport Performance Clinical Trial

Official title:

Effects of Probiotic Supplementation on Sport Performance and Gut Damage in Females CrossFit Athletes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06220110
• Other study ID #: Lact.Bas.F
• Status: Completed
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: January 2024
• Source: University of the Basque Country (UPV/EHU)
• Contact: n/a
• Is FDA regulated: No
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy

• No injuries

• 1 year of CrossFit practicing experience

Exclusion Criteria:

• Drug, alcohol, cigarettes, probiotic intake

• Injuries

Related Conditions & MeSH terms

• Gut Damage
• Sport Performance

Intervention

Dietary Supplement:
• Probiotic
Probiotic capsules will be composed of 10 billion CFU of Lactobacillus plantarum.
• Placebo
Capsules containing dextrose (1 capsule per day)

Locations

Country	Name	City	State
Spain	CrossFit Bikain	Vitoria	Alava

Sponsors (1)

Lead Sponsor	Collaborator
University of the Basque Country (UPV/EHU)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intestinal-fatty acid-binding protein	Gut damage marker	0-10 minutes after strenuous exercise blood samples will be extracted
Primary	Counter movement jump test	Jumping test	24 hours after strenuous training session. First test to be performed
Primary	Running Based Anaerobic Sprint Test	Running test	24 hours after strenuous training session. Second test to be performed
Primary	YO YO Intermittent Recovery Level test 1	aerobic test	24 hours after strenuous training session. Third test to be performed