Probiotic Supplementation on Sport Performance and Gut Damage in Females

NCT ID: NCT06220110

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-15
• Study Completion Date: 2023-12-15

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental group

Probiotic intake containing 10 billions of Colony Forming Units of Lactobacillus plantarum (1 capsule per day)

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Probiotic capsules will be composed of 10 billion CFU of Lactobacillus plantarum.

Placebo group

Placebo intake. Placebo capsules will contain dextrose (1 capsule per day)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Capsules containing dextrose (1 capsule per day)

Interventions

Probiotic

Probiotic capsules will be composed of 10 billion CFU of Lactobacillus plantarum.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Capsules containing dextrose (1 capsule per day)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Healthy
• No injuries
• 1 year of CrossFit practicing experience

Exclusion Criteria

• Drug, alcohol, cigarettes, probiotic intake
• Injuries

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of the Basque Country (UPV/EHU)

OTHER

Sponsor Role: lead

Responsible Party

Asier Santibañez

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Asier Santibañez, MsC

Role: PRINCIPAL_INVESTIGATOR

University of the Basque Country (UPV/EHU)

Locations

CrossFit Bikain

Vitoria-Gasteiz, Alava, Spain

Countries

Spain

Other Identifiers

Lact.Bas.F

Identifier Type: -

Identifier Source: org_study_id