StressPhase 2NCT05545813
Impact of Probiotic Supplementation on Cognition and Related Health Outcomes Among Video Gamers
A Phase 2 study testing Probiotic in people with Stress and Attention Disturbances, run by Lallemand Health Solutions at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Attention Disturbances
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jan 2023to 21 Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Cognitive and Motor Performance Lab, Dalplex, Kinesiology Suites, Dalhousie University (Rm. 213)
Halifax, Nova Scotia, B3H4R2
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress, Attention Disturbances
- Being tested
- Probiotic, Placebo
- Keywords
- Attention, Cognition, Acute Stress, Task-switching, Probiotics, HPA-axis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Participants will be asked to take 1 capsule (3 billion CFU) daily for 8 weeks in the morning with their first meal.
PlaceboDietary supplement
Participants will be asked to take 1 capsule daily for 8 weeks in the morning with their first meal.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Participants will be randomized to receive the probiotic formulation for 8 weeks. Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Participants will be randomized to receive the placebo formulation for 8 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in reaction time
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.
Measured: 8 weeks
Secondary outcomes (15)
Change in reaction time: acute stress condition
The statistical difference in changes in reaction time (in milliseconds) on a computerized incongruent CWST between probiotic and placebo groups following acute stress.
Measured: 8 weeks
Change in accuracy: acute stress condition
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.
Measured: 8 weeks
Change in reaction time: non-stressful condition
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.
Measured: 8 weeks
Change in accuracy: non-stressful condition
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.
Measured: 8 weeks
Change in self-reported cognitive control: non-stressful condition
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.
Measured: 8 weeks
Changes in oxyhemoglobin concentrations in pre-frontal cortex
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.
Measured: 8 weeks
Changes in cortisol
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.
Measured: 8 weeks
Changes in salivary DHEA-S
The statistical difference in salivary DHEA-S from baseline between the probiotic and placebo groups.
Measured: 8 weeks
Changes in salivary cortisol/DHEA-S ratio
The statistical difference in the salivary cortisol/DHEA-S ratio from baseline between the probiotic and placebo groups.
Measured: 8 weeks
Changes in immune activity markers
The statistical difference in changes in salivary levels of proinflammatory cytokines, interleukin-1 beta, and interleukin-6 from baseline between probiotic and placebo groups.
Measured: 8 weeks
Changes in self-reported levels of depression symptomology
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.
Measured: 8 weeks
Changes in self-reported levels of anxiety symptomology
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.
Measured: 8 weeks
Changes in self-reported levels of perceived stress symptomology
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.
Measured: 8 weeks
Changes in self-reported levels of anxiety, depression, and perceived stress symptomology
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.
Measured: 8 weeks
Changes in self-reported sleep quality
The statistical differences in changes in total Pittsburgh Sleep Quality Index (PSQI) scores between the probiotic and placebo groups.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start21 Jan 2023
- Primary completion21 Nov 2023
- Study completion21 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo-controlled, double-blinded.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lallemand Health Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dalhousie University
- Responsible party
- Sponsor
- Investigators
- Tara Perrot, Ph.D., Principal investigator, Dalhousie UniversityHeather Neyedli, Ph.D., Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545813
- Sponsor's protocol ID
- L-025
- Status last verified
- Sep 2023
- First submitted
- 2 Sep 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Probiotic Supplementation on Cognition and Related Health Outcomes Among Video Gamers: A Randomized, Placebo-Controlled, Double-Blind, Clinical Trial
- ClinicalTrials.gov ID
- NCT05545813
- Acronym / sponsor ID
- L-025
- Conditions
- Stress, Attention Disturbances
- Keywords
- Attention, Cognition, Acute Stress, Task-switching, Probiotics, HPA-axis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Lallemand Health SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Dalhousie University
- Study start
- 21 Jan 2023 (actual)
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 21 Nov 2023 (actual)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, placebo-controlled, double-blinded.
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticParticipants will be randomized to receive the probiotic formulation for 8 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants will be randomized to receive the placebo formulation for 8 weeks. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticParticipants will be asked to take 1 capsule (3 billion CFU) daily for 8 weeks in the morning with their first meal. | Dietary supplement | Probiotic |
| PlaceboParticipants will be asked to take 1 capsule daily for 8 weeks in the morning with their first meal. | Dietary supplement | Placebo |
Primary outcome
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.
15 secondary outcomes
Change in reaction time: acute stress condition
Time frame: 8 weeks
Change in accuracy: acute stress condition
Time frame: 8 weeks
Change in reaction time: non-stressful condition
Time frame: 8 weeks
Change in accuracy: non-stressful condition
Time frame: 8 weeks
Change in self-reported cognitive control: non-stressful condition
Time frame: 8 weeks
Changes in oxyhemoglobin concentrations in pre-frontal cortex
Time frame: 8 weeks
Changes in cortisol
Time frame: 8 weeks
Changes in salivary DHEA-S
Time frame: 8 weeks
Changes in salivary cortisol/DHEA-S ratio
Time frame: 8 weeks
Changes in immune activity markers
Time frame: 8 weeks
Changes in self-reported levels of depression symptomology
Time frame: 8 weeks
Changes in self-reported levels of anxiety symptomology
Time frame: 8 weeks
Changes in self-reported levels of perceived stress symptomology
Time frame: 8 weeks
Changes in self-reported levels of anxiety, depression, and perceived stress symptomology
Time frame: 8 weeks
Changes in self-reported sleep quality
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tara Perrot, Ph.D. principal investigator
Dalhousie University
Heather Neyedli, Ph.D. principal investigator
Dalhousie University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic in people with Stress and Attention Disturbances, run by Lallemand Health Solutions at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in reaction time (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.