Impact of Probiotic Supplementation on Cognition and Related Health Outcomes Among Video Gamers

NCT05545813 | Completed Phase 2

• 1 other identifier: L-025
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Attention Disturbances

Keywords

Attention; Cognition; Acute Stress; Task-switching; Probiotics; HPA-axis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (15)

• Change in reaction time: acute stress condition

  8 weeks

• Change in accuracy: acute stress condition

  8 weeks

• Change in reaction time: non-stressful condition

  8 weeks

• Change in accuracy: non-stressful condition

  8 weeks

• Change in self-reported cognitive control: non-stressful condition

  8 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

Participants will be randomized to receive the probiotic formulation for 8 weeks.

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Participants will be randomized to receive the placebo formulation for 8 weeks.

Dietary Supplement: Placebo

Interventions

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.

Probiotic

Placebo DIETARY_SUPPLEMENT

Participants will be asked to take 1 capsule daily for 8 weeks in the morning with their first meal.

Placebo

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lallemand Health Solutions: lead
• Dalhousie University: collaborator

Study Sites (1)

Cognitive and Motor Performance Lab, Dalplex, Kinesiology Suites, Dalhousie University (Rm. 213)

Halifax, Nova Scotia, B3H4R2, Canada

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Tara Perrot, Ph.D.

  Dalhousie University

  PRINCIPAL INVESTIGATOR

• Heather Neyedli, Ph.D.

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, placebo-controlled, double-blinded.

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 19, 2022
• Study Start: January 21, 2023
• Primary Completion: November 21, 2023
• Study Completion: November 21, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)