Impact of Probiotic Supplementation on Cognition and Related Health Outcomes Among Video Gamers: A Randomized, Placebo-Controlled, Double-Blind, Clinical Trial

Lallemand Health Solutions1 site in 1 country36 target enrollmentJanuary 21, 2023

ConditionsStress Attention Disturbances

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Stress
Sponsor: Lallemand Health Solutions
Enrollment: 36
Locations: 1
Primary Endpoint: Change in reaction time
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of the current study is to investigate the effect of two probiotic formulations on task-switching following acute stress in healthy, adult action video gamers. It is hypothesized that the participants that consume the probiotic formulations will have improved task-switching performance following acute stress compared to those who consume a placebo.

Detailed Description

Participants who are action gamers will be recruited to participate in this randomized, placebo-controlled, 2-arm, parallel trial. Eligible participants will be enrolled in this study for 8 weeks. The study will consist of 2 laboratory visits: Baseline Visit and Post-Treatment Visit.

Registry

clinicaltrials.gov

Start Date

January 21, 2023

End Date

November 21, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Lallemand Health Solutions

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female adults aged 19 to 35 years-old.
•Have played action video games (i.e., first- and third-person shooter and action role playing games) for a minimum of 5 hours per week over the course of the previous year as assessed by self-report (as per \[1\])
•Willingness to continue the same amount of video game playing throughout the duration of the study.
•Willingness to maintain eating habits throughout the duration of the study.
•Willingness to discontinue consumption of probiotic supplements and probiotic- fortified products, as well as fiber supplement consumption (e.g., Metamucil, Benefiber, etc.), throughout the duration of the study.
•Willingness to maintain current physical activity levels throughout the duration of the study.
•Willing and able to consume a probiotic or placebo supplement for 8 weeks.
•Willingness to complete questionnaires, records, and diaries associated with the study and to complete all study visits.
•Able to provide informed consent.

Exclusion Criteria

•Use of antidepressants, anti-anxiolytic medication, and/or medication that improves attention, including amphetamines, methylphenidates, dexmethylphenidates, and atomoxetine hydrochloride.
•Disordered gaming, as per a score above 32 on the Internet Gaming Disorder Scale Short Form (IGDS9-SF; \[2\]).
•Head trauma that was diagnosed by a medical professional as a concussion or was associated with a loss of consciousness within the past two years.
•Currently diagnosed with alcohol use disorder and/or substance use disorder.
•Diabetes (type I and II), blood/bleeding disorders, liver and/or kidney disorders, unstable cardiovascular diseases, neurological diseases (e.g., Alzheimer's disease, Parkinson's disease, epilepsy), gastrointestinal diseases (e.g., gastric ulcers, Crohn's disease, ulcerative colitis).
•Presence of unrelated sleep disorders, diagnosis of a mental disorder within the previous year, history of diagnosis of attention-deficit/hyperactivity disorder or attention-deficit disorder
•Immunodeficiency (immune-compromised and immune-suppressed participants; e.g., AIDS, lymphoma, participants undergoing long-term corticosteroid treatment, chemotherapy and allograft participants).
•Arthritis pain or other chronic pain.
•Currently suffering from periodontitis.
•Pregnancy (as per urine pregnancy test at screening), planning to be pregnant or currently breastfeeding.

Outcomes

Primary Outcomes

Change in reaction time

Time Frame: 8 weeks

The statistical difference in change in reaction time (in milliseconds) from baseline during a computerized task-switching color-word Stroop task following acute stress between the probiotic and placebo groups.

Secondary Outcomes

Changes in cortisol(8 weeks)
Changes in salivary DHEA-S(8 weeks)
Changes in self-reported levels of depression symptomology(8 weeks)
Changes in self-reported levels of perceived stress symptomology(8 weeks)
Change in reaction time: acute stress condition(8 weeks)
Change in accuracy: acute stress condition(8 weeks)
Change in reaction time: non-stressful condition(8 weeks)
Change in accuracy: non-stressful condition(8 weeks)
Change in self-reported cognitive control: non-stressful condition(8 weeks)
Changes in oxyhemoglobin concentrations in pre-frontal cortex(8 weeks)
Changes in immune activity markers(8 weeks)
Changes in self-reported levels of anxiety symptomology(8 weeks)
Changes in self-reported sleep quality(8 weeks)
Changes in salivary cortisol/DHEA-S ratio(8 weeks)
Changes in self-reported levels of anxiety, depression, and perceived stress symptomology(8 weeks)