Impact of Probiotic Supplementation on Cognition and Related Health Outcomes Among Video Gamers
NCT ID: NCT05545813
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
36 participants
INTERVENTIONAL
2023-01-21
2023-11-21
Brief Summary
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Detailed Description
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The study will consist of 2 laboratory visits: Baseline Visit and Post-Treatment Visit.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Probiotic
Participants will be randomized to receive the probiotic formulation for 8 weeks.
Probiotic
Participants will be asked to take 1 capsule (3 billion CFU) daily for 8 weeks in the morning with their first meal.
Placebo
Participants will be randomized to receive the placebo formulation for 8 weeks.
Placebo
Participants will be asked to take 1 capsule daily for 8 weeks in the morning with their first meal.
Interventions
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Probiotic
Participants will be asked to take 1 capsule (3 billion CFU) daily for 8 weeks in the morning with their first meal.
Placebo
Participants will be asked to take 1 capsule daily for 8 weeks in the morning with their first meal.
Eligibility Criteria
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Inclusion Criteria
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
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.
19 Years
35 Years
ALL
Yes
Sponsors
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Dalhousie University
OTHER
Lallemand Health Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Tara Perrot, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Dalhousie University
Heather Neyedli, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Dalhousie University
Locations
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Cognitive and Motor Performance Lab, Dalplex, Kinesiology Suites, Dalhousie University (Rm. 213)
Halifax, Nova Scotia, Canada
Countries
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Other Identifiers
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L-025
Identifier Type: -
Identifier Source: org_study_id