- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05545813
Impact of Probiotic Supplementation on Cognition and Related Health Outcomes Among Video Gamers
November 28, 2023 updated by: Lallemand Health Solutions
Impact of Probiotic Supplementation on Cognition and Related Health Outcomes Among Video Gamers: A Randomized, Placebo-Controlled, Double-Blind, Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cory Munroe, Ph.D. candidate
- Phone Number: (902)-574-4567
- Email: cory.munroe@dal.ca
Study Contact Backup
- Name: Sara E Caballero Calero, M.Sc
- Phone Number: 514-283-1387
- Email: scaballero@lallemand.com
Study Locations
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H4R2
- Cognitive and Motor Performance Lab, Dalplex, Kinesiology Suites, Dalhousie University (Rm. 213)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Description
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.
- 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.
- Milk, soy, and/or yeast allergy.
- Lactose intolerance.
- Use of any antibiotic drug within 4 weeks of randomization. Volunteer could be eligible to participate after a 2-week washout period.
- Current use of probiotics. Volunteer can be eligible after a four (4)-week washout period.
- Currently enrolled in another clinical trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Probiotic
Participants will be randomized to receive the probiotic formulation for 8 weeks.
|
Participants will be asked to take 1 capsule (3 billion CFU) daily for 8 weeks in the morning with their first meal.
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Placebo Comparator: Placebo
Participants will be randomized to receive the placebo formulation for 8 weeks.
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Participants will be asked to take 1 capsule daily for 8 weeks in the morning with their first meal.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in reaction time: acute stress condition
Time Frame: 8 weeks
|
The statistical difference in changes in reaction time (in milliseconds) on a computerized incongruent CWST between probiotic and placebo groups following acute stress.
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8 weeks
|
Change in accuracy: acute stress condition
Time Frame: 8 weeks
|
The statistical difference in changes in accuracy (proportion correct) on a computerized task-switching CWST and incongruent CWST between probiotic and placebo groups following acute stress.
|
8 weeks
|
Change in reaction time: non-stressful condition
Time Frame: 8 weeks
|
The statistical difference in changes in reaction time (in milliseconds) on a computerized task-switching and incongruent CWST and a visual search (VS) paradigm, between probiotic and placebo groups in a non-stressful condition.
|
8 weeks
|
Change in accuracy: non-stressful condition
Time Frame: 8 weeks
|
The statistical difference in changes in accuracy (proportion correct; %false alarms) on a computerized task-switching and an incongruent CWST, a go/no-go paradigm, a visual working memory maintenance paradigm, and a visual working memory complex span task (SYMSPAN) between probiotic and placebo groups in a non-stressful condition.
|
8 weeks
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Change in self-reported cognitive control: non-stressful condition
Time Frame: 8 weeks
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The statistical difference in changes in self-reported cognitive control and cognitive flexibility as per the Cognitive Control and Flexibility Questionnaire (CCFQ) between probiotic and placebo groups in a non-stressful condition.
|
8 weeks
|
Changes in oxyhemoglobin concentrations in pre-frontal cortex
Time Frame: 8 weeks
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The statistical difference in changes in concentrations of oxygenated hemoglobin in the prefrontal cortex (PFC) during the task-switching CWST from baseline between the probiotic and placebo groups following acute stress and under non-stress conditions.
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8 weeks
|
Changes in cortisol
Time Frame: 8 weeks
|
The statistical difference in changes in the cortisol response to acute stress from baseline, as measured by the area under the curve with respect to increase (AUCi) and with respect to ground (AUCg) between probiotic and placebo groups.
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8 weeks
|
Changes in salivary DHEA-S
Time Frame: 8 weeks
|
The statistical difference in salivary DHEA-S from baseline between the probiotic and placebo groups.
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8 weeks
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Changes in salivary cortisol/DHEA-S ratio
Time Frame: 8 weeks
|
The statistical difference in the salivary cortisol/DHEA-S ratio from baseline between the probiotic and placebo groups.
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8 weeks
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Changes in immune activity markers
Time Frame: 8 weeks
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The statistical difference in changes in salivary levels of proinflammatory cytokines, interleukin-1 beta, and interleukin-6 from baseline between probiotic and placebo groups.
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8 weeks
|
Changes in self-reported levels of depression symptomology
Time Frame: 8 weeks
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The statistical difference in changes in the depression subscale score of the Depression, Anxiety, and Stress Scale Short Form (DASS-21) from baseline between the probiotic and placebo groups.
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8 weeks
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Changes in self-reported levels of anxiety symptomology
Time Frame: 8 weeks
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The statistical difference in changes in the anxiety subscale score of the Depression, Anxiety, and Stress Scale Short Form (DASS-21) from baseline between the probiotic and placebo groups.
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8 weeks
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Changes in self-reported levels of perceived stress symptomology
Time Frame: 8 weeks
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The statistical difference in changes in the stress subscale score of the Depression, Anxiety, and Stress Scale Short Form (DASS-21) from baseline between the probiotic and placebo groups.
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8 weeks
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Changes in self-reported levels of anxiety, depression, and perceived stress symptomology
Time Frame: 8 weeks
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The statistical difference in changes in the total scale score of the Depression, Anxiety, and Stress Scale Short Form (DASS-21) between the probiotic and placebo groups.
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8 weeks
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Changes in self-reported sleep quality
Time Frame: 8 weeks
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The statistical differences in changes in total Pittsburgh Sleep Quality Index (PSQI) scores between the probiotic and placebo groups.
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8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Tara Perrot, Ph.D., Dalhousie University
- Principal Investigator: Heather Neyedli, Ph.D., Dalhousie University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 21, 2023
Primary Completion (Actual)
November 21, 2023
Study Completion (Actual)
November 21, 2023
Study Registration Dates
First Submitted
September 2, 2022
First Submitted That Met QC Criteria
September 15, 2022
First Posted (Actual)
September 19, 2022
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 28, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- L-025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
After publications of the results, de-identified data will be shared with qualified researchers and scientists upon reasonable request to the sponsor including a detailed proposal of the intended use of the data, as per the Lallemand Health Solutions Inc. Policy on Clinical Trial Transparency and Data Sharing (available upon request).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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