Clinical trial NCT05545813: Impact of Probiotic Supplementation on Cognition and Related Health Outcomes Among Video Gamers
Official title: Impact of Probiotic Supplementation on Cognition and Related Health Outcomes Among Video Gamers: A Randomized, Placebo-Controlled, Double-Blind, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stress
Attention Disturbances
Keywords: Attention
Cognition
Acute Stress
Task-switching
Probiotics
HPA-axis
Lead sponsor: Lallemand Health Solutions
Sponsor class: INDUSTRY
Collaborators: name: Dalhousie University
First posted: 2022-09-19
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo-controlled, double-blinded.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. Male and female adults aged 19 to 35 years-old.
2. 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 \[1\])
3. Willingness to continue the same amount of video game playing throughout the duration of the study.
4. Willingness to maintain eating habits throughout the duration of the study.
5. 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.
6. Willingness to maintain current physical activity levels throughout the duration of the study.
7. Willing and able to consume a probiotic or placebo supplement for 8 weeks.
8. Willingness to complete questionnaires, records, and diaries associated with the study and to complete all study visits.
9. Able to provide informed consent.

Exclusion Criteria:

1. Use of antidepressants, anti-anxiolytic medication, and/or medication that improves attention, including amphetamines, methylphenidates, dexmethylphenidates, and atomoxetine hydrochloride.
2. Disordered gaming, as per a score above 32 on the Internet Gaming Disorder Scale Short Form (IGDS9-SF; \[2\]).
3. 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.
4. Currently diagnosed with alcohol use disorder and/or substance use disorder.
5. 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).
6. 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
7. Immunodeficiency (immune-compromised and immune-suppressed participants; e.g., AIDS, lymphoma, participants undergoing long-term corticosteroid treatment, chemotherapy and allograft participants).
8. Arthritis pain or other chronic pain.
9. Currently suffering from periodontitis.
10. Pregnancy (as per urine pregnancy test at screening), planning to be pregnant or currently breastfeeding.
11. Females of childbearing potential not using a medically approved method of birth control (e.g. hormonal contraception, intrauterine devices, vasectomy/tubal ligation, barrier methods, double-barrier method) or true abstinence.
12. Milk, soy, and/or yeast allergy.
13. Lactose intolerance.
14. Use of any antibiotic drug within 4 weeks of randomization. Volunteer could be eligible to participate after a 2-week washout period.
15. Current use of probiotics. Volunteer can be eligible after a four (4)-week washout period.
16. Currently enrolled in another clinical trial.

Primary outcomes:
measure: Change in reaction time
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in reaction time: acute stress condition
timeFrame: 8 weeks
measure: Change in accuracy: acute stress condition
timeFrame: 8 weeks
measure: Change in reaction time: non-stressful condition
timeFrame: 8 weeks
measure: Change in accuracy: non-stressful condition
timeFrame: 8 weeks
measure: Change in self-reported cognitive control: non-stressful condition
timeFrame: 8 weeks
measure: Changes in oxyhemoglobin concentrations in pre-frontal cortex
timeFrame: 8 weeks
measure: Changes in cortisol
timeFrame: 8 weeks
measure: Changes in salivary DHEA-S
timeFrame: 8 weeks
measure: Changes in salivary cortisol/DHEA-S ratio
timeFrame: 8 weeks
measure: Changes in immune activity markers
timeFrame: 8 weeks
measure: Changes in self-reported levels of depression symptomology
timeFrame: 8 weeks
measure: Changes in self-reported levels of anxiety symptomology
timeFrame: 8 weeks
measure: Changes in self-reported levels of perceived stress symptomology
timeFrame: 8 weeks
measure: Changes in self-reported levels of anxiety, depression, and perceived stress symptomology
timeFrame: 8 weeks
measure: Changes in self-reported sleep quality
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Cognitive and Motor Performance Lab, Dalplex, Kinesiology Suites, Dalhousie University (Rm. 213)
state: Nova Scotia
Study officials:
affiliation: Dalhousie University
name: Tara Perrot, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dalhousie University
name: Heather Neyedli, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: