Probiotic Supplementation in Sport Performance and Gut Damage

Sponsor

University of the Basque Country (UPV/EHU) (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05350176

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

23.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sport Performance Gut Damage	Dietary Supplement: Probiotic Dietary Supplement: Placebo	N/A

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, sports performance test, and a blood sample of the participants will be collected (at rest). After one week, a strenuous exercise session will be performed in order to observe the variation of the intestinal damage marker. 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 Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effects of Probiotic Supplementation on Sport Performance and Gut Damage in Basketball Players

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Intestinal-fatty acid-binding protein [10-30 minutes after strenuous exercise blood samples will be extracted]
Gut damage marker
Counter movement jump test [24 hours after strenuous training session. First test to be performed]
Jumping test
Running Based Anaerobic Sprint Test [24 hours after strenuous training session. Third test to be performed]
Running test
Isokinetic strength test [24 hours after strenuous training session. Second test to be performed]
Strength test
YO YO Intermittent Recovery Level test 1 [24 hours after strenuous training session. Fourth test to be performed]
aerobic test

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy
No injuries
3 years of basketball experience

Exclusion Criteria:

Drug, alcohol, cigarettes, probiotic intake
Injuries

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Sport and Physical Education	Novi Sad	Voivodina	Serbia	21000

Sponsors and Collaborators

University of the Basque Country (UPV/EHU)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Asier Santibañez, MsC, University of the Basque Country (UPV/EHU)

ClinicalTrials.gov Identifier:

NCT05350176

Other Study ID Numbers:

Lact.Bas

First Posted:

Apr 28, 2022

Last Update Posted:

May 3, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Asier Santibañez, MsC, University of the Basque Country (UPV/EHU)

Probiotic

Gut damage

Sport performance

Study Results

No Results Posted as of May 3, 2022