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| Name | Class |
|---|---|
| Dalhousie University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Participants will be randomized to receive the probiotic formulation for 8 weeks. |
|
| Placebo | Placebo Comparator | Participants will be randomized to receive the placebo formulation for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Participants will be asked to take 1 capsule (3 billion CFU) daily for 8 weeks in the morning with their first meal. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Change in accuracy: acute stress condition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tara Perrot, Ph.D. | Dalhousie University | Principal Investigator |
| Heather Neyedli, Ph.D. | Dalhousie University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cognitive and Motor Performance Lab, Dalplex, Kinesiology Suites, Dalhousie University (Rm. 213) | Halifax | Nova Scotia | B3H4R2 | Canada |
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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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Randomized, placebo-controlled, double-blinded.
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| Placebo | Dietary Supplement | Participants will be asked to take 1 capsule daily for 8 weeks in the morning with their first meal. |
|
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 | 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 | 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 |
| 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. | 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. | 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. | 8 weeks |
| Changes in salivary DHEA-S | The statistical difference in salivary DHEA-S from baseline between the probiotic and placebo groups. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 8 weeks |
| D019602 |
| Food and Beverages |