Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-25 @ 3:16 AM
NCT ID:
NCT07047105
Eligibility Criteria:
Inclusion Criteria:
* Aged 16 to 34 years inclusive
* Males and females
* Self-report of good health
* Usually a regular (at least once per week) player of competitive multiplayer games, (prospective participants will be asked to contact the researchers to discuss their gaming habits if uncertain that they meet the criteria).
Exclusion Criteria:
* Have any pre-existing medical condition/illness which will impact taking part in the study (i.e. participants may be allowed to progress to screening if they have a condition/illness which would not interact with the active treatments or impede performance).
* Are currently taking prescription medications NOTE: the explicit exceptions to this are contraceptive treatments for female participants, and those taken 'as needed' in the treatment of asthma and hay fever. There may be other instances of medication use which, where no interaction with the active treatments is likely, and which would not be expected to have any impact on brain function, participants may be able to progress to screening.
* Have high blood pressure (systolic over 139 mm Hg or diastolic over 89 mm Hg); or have low blood pressure (systolic below 90 mm Hg or diastolic below 60 mm Hg)
* Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2
* Are pregnant, seeking to become pregnant or lactating
* Have learning and/or behavioural diagnoses such as dyslexia or ADHD
* Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness)
* Smoke tobacco or vape nicotine or use nicotine replacement products
* Excessive caffeine intake (\> 500 mg per day). If participants consume energy drinks they will be asked to refrain from this for 24 hour prior to attending testing.
* Have relevant food intolerances/sensitivities, including caffeine sensitivity.
* Have taken antibiotics within the past 4 weeks
* Have taken dietary supplements e.g. Vitamins, omega 3 fish oils etc. in the last 4 weeks (Note: participation is possible following a 4-week supplement washout prior to participating and for the duration of the study on the proviso that the supplements they are taken are out of choice and not medically prescribed or advised)
* Have any health condition that would prevent fulfilment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken)
* Are unable to complete all of the study assessments
* Are currently participating in other clinical or nutrition intervention studies, or have done so in the past 4 weeks
* Has been diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months
* Have been diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months
* Suffers from frequent migraines that require medication (more than or equal to 1 per month)
* Sleep disorders or are taking sleep aid medication
* Any known active infections
* Are non-compliant with regards treatment consumption
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
34 Years
Study:
NCT07047105
Study Brief:
Protocol Section:
NCT07047105