Probiotic Supplementation on Sport Performance and Gut Damage in Females

January 23, 2024 updated by: Asier Santibañez, University of the Basque Country (UPV/EHU)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alava
      • Vitoria, Alava, Spain, 01015
        • CrossFit Bikain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Drug, alcohol, cigarettes, probiotic intake
  • Injuries

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Probiotic intake containing 10 billions of Colony Forming Units of Lactobacillus plantarum (1 capsule per day)
Dietary supplement: Probiotic
Probiotic capsules will be composed of 10 billion CFU of Lactobacillus plantarum.
Placebo Comparator: Placebo group
Placebo intake. Placebo capsules will contain dextrose (1 capsule per day)
Dietary supplement: Placebo
Capsules containing dextrose (1 capsule per day)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Basque Country (UPV/EHU)

Investigators

  • Principal Investigator: Asier Santibañez, MsC, University of the Basque Country (UPV/EHU)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2023

Primary Completion (Actual)

November 15, 2023

Study Completion (Actual)

December 15, 2023

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 12, 2024

First Posted (Actual)

January 23, 2024

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Lact.Bas.F

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sport Performance

Clinical Trials on Probiotic

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe