Decoding Gut-Brain Biomarkers and Developing a Minimally Intrusive Gut Microbiome Sampling: Enhancing Cognitive Well-being in Athletes

NCT07093112 | Active Not Recruiting

• 1 other identifier: HSC-MS-24-0876
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess the impact of a psychobiotic supplement on the gut health, neurological markers, and behavior of younger soccer players over the soccer season.

Conditions

Athletic Performance; Gut Health

Outcome Measures

Primary Outcomes (6)

• Recovery Process as Assessed by the Questionario de Estresse e Recuperacao para Atletas (RESTQ-Sport) - Stress Subscale

  The Questionário de Estresse e Recuperação para Atletas (RESTQ-Sport) assesses stress and recovery in athletes across 19 multidimensional scales: seven for general stress, five for general recovery, three for sports-specific stress, and four for sports-specific recovery. The RESTQ-Sport measures how well athletes recover from physical and mental stress over the previous three days and nights, providing a comprehensive understanding of their overall recovery status. The stress subscale score will be transformed into a percentage for a total score ranging from 0 to 100. A higher score on the stress subscale indicates a worse outcome (higher stress).

  baseline, 30 days, 1 year

• Recovery Process as Assessed by the Questionario de Estresse e Recuperacao para Atletas (RESTQ-Sport) - Recovery Subscale

  The Questionário de Estresse e Recuperação para Atletas (RESTQ-Sport) assesses stress and recovery in athletes across 19 multidimensional scales: seven for general stress, five for general recovery, three for sports-specific stress, and four for sports-specific recovery. The RESTQ-Sport measures how well athletes recover from physical and mental stress over the previous three days and nights, providing a comprehensive understanding of their overall recovery status. The recovery subscale score will be transformed into a percentage for a total score ranging from 0 to 100. A higher score on the recovery subscale indicates a better outcome (better recovery).

  baseline, 30 days, 1 year

• Preparation for Injury Prevention as Assessed by the Musculoskeletal Injury Readiness Questionnaire (MIR-Q)

  This questionnaire was developed for use with Brazilian athletes, particularly focusing on screening for musculoskeletal injury risks in various sports populations. One overall score will be reported, and the score will be transformed into a percentage for a total score ranging from 0 to 100. A higher score indicates a better outcome, suggesting that the athlete is more prepared for injury prevention.

  baseline, 30 days, 1 year

• Overtraining as assessed by the Overtraining Questionnaire

  The Overtraining Questionnaire measures overtraining syndrome in athletes, focusing on physical, psychological, social, and physiological factors, and it is designed to identify early signs of overtraining and prevent further progression of symptoms. The Brazilian adaptation will be used. The questionnaire is divided into six subscales: performance, psychological state, physiological responses, social factors, nutrition, and infection. One overall score will be reported, and the score will be transformed into a percentage for a total score ranging from 0 to 100. A higher score indicates a worse outcome, representing a higher risk or symptoms of overtraining.

  baseline, 30 days, 1 year

• Psychological distress as Assessed by the General Anxiety Disorder-7 (GAD-7)

  The Generalized Anxiety Disorder-7 (GAD-7) focusses on symptoms like excessive worry and difficulty controlling anxiety, as well as physical symptoms such as restlessness and fatigue. The GAD-7 was adapted for Brazilian Portuguese for use with the general adult population and has been validated for different age groups, including adolescents in Brazil. One overall score will be reported, and the score will be transformed into a percentage for a total score ranging from 0 to 100. A higher score indicates a worse outcome (greater anxiety).

  baseline, 30 days, 1 year

• Psychological distress as Assessed by the Patient Depression Questionnaire - Adolescents (PHQ-A)

  The Patient Health Questionnaire-9 (PHQ-9) measures the severity of depressive symptoms in clinical and non-clinical populations. It consists of nine items that assess the frequency of depressive symptoms over the past two weeks. The PHQ-9 was adapted for Brazilian Portuguese and validated among adults in the general population in Pelotas, Brazil. Each item is rated on a scale from 0 (not at all) to 3 (nearly every day), providing a total depression severity score. The score will be transformed into a percentage for a total score ranging from 0 to 100, and this will be reported. A higher score indicates a worse outcome (i.e., greater depressive symptoms).

  baseline, 30 days, 1 year

Secondary Outcomes (8)

• Psychological distress as Assessed by the Athletic Coping Skills Inventory - Brazilian Portuguese version (ACSI-25BR)

  baseline, 30 days, 1 year

• Cognitive function as Indicated by Impulsivity as Assessed by the Delay Discounting Task (DD)

  baseline, 30 days, 1 year

• Cognitive function as Assessed by the Barkley Deficits in Executive Functioning Scale (BDEF)

  baseline, 30 days, 1 year

• Cognitive function as Assessed by the Trail Making Test (TMT)

  baseline, 30 days, 1 year

• Cognitive function as Assessed by the Verbal Fluency Test (VFT)

  baseline, 30 days, 1 year

Study Arms (2)

Psychobiotic supplement

EXPERIMENTAL

Dietary Supplement: Psychobiotic supplement

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Psychobiotic supplement DIETARY_SUPPLEMENT

The psychobiotic supplement consists of Bifidobacterium lactis CCT 7858 and Lactobacillus rhamnosus CCT 7863, at a final concentration of 1 x 10\^10 CFU/g (GABBIA® Biotechnology, Santa Catarina, Brazil). The intervention will be administered once daily for 90 days, spanning the pre-season and start-season phases with an interval and restarting for 90 days until the end-season phase.

Psychobiotic supplement

Placebo DIETARY_SUPPLEMENT

The placebo consists of maltodextrin. The intervention will be administered once daily for 90 days, spanning the pre-season and start-season phases with an interval and restarting for 90 days until the end-season phase.

Placebo

Eligibility Criteria

• Age: 14 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• soccer player affiliated with Criciúma Esporte Clube (CEC)'s base in Criciúma, Santa Catarina, Brazil
• agree to participate voluntarily

You may not qualify if:

• athletes who withdraw from the study, cannot collect biological samples or answer the questionnaires during the pre-established times, and fail to take the capsules recommended in the study

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Universidade do Extremo Sul Catarinense (UNESC): collaborator
• National Football League Players Association (NFLPA): collaborator

Study Sites (1)

Universidade do Extremo Sul Catarinense (UNESC)

Criciúma, Santa Catarina, 88806-000, Brazil

Location

Study Officials

• Tatiana Barichello, PhD

  The University of Texas Health Science Center, Houston

  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: Associate Professor

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: July 30, 2025
• Study Start: March 10, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)