NCT05350176

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 22, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
1.5 years until next milestone

Study Start

First participant enrolled

October 10, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

January 24, 2024

Status Verified

January 1, 2024

Enrollment Period

1 month

First QC Date

April 22, 2022

Last Update Submit

January 23, 2024

Conditions

Keywords

ProbioticGut damageSport performance

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

EXPERIMENTAL

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

Dietary Supplement: Probiotic

Placebo group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

ProbioticDIETARY_SUPPLEMENT

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

Experimental group
PlaceboDIETARY_SUPPLEMENT

Capsules containing dextrose (1 capsule per day)

Placebo group

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Asier Santibañez, MsC

    University of the Basque Country (UPV/EHU)

    PRINCIPAL INVESTIGATOR

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
MsC

Study Record Dates

First Submitted

April 22, 2022

First Posted

April 28, 2022

Study Start

October 10, 2023

Primary Completion

November 20, 2023

Study Completion

December 20, 2023

Last Updated

January 24, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations