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:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
NCT ID:
NCT05544500
Eligibility Criteria:
Inclusion Criteria:
* Participants must self-assess themselves as being in good health
* Aged 18 to 35 years at the time of giving consent
* Report good oral health and chewing ability
* Proficient in English
Exclusion Criteria:
* Have any pre-existing medical condition/illness which will impact taking part in the study NOTE: There may be unforeseen, exceptions and these will be considered on a case-by-case basis; 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 exception to this are contraceptive treatments for female participants, topical skin treatments e.g. for eczema, acne, and those taken 'as needed' in the treatment of hay fever. As above, 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. Use of any medications which impact mood or cognitive function e.g. anti depressants, anti anxiety medications etc. are not permitted.
* Have undergone dental treatment 1 week before the test, or needs or is planning dental treatments during the study (excluding routine dental check-up)
* Have a Body Mass Index (BMI) outside of the range 18.5-30 kg/m2
* Are pregnant, seeking to become pregnant or lactating.
* Have a visual impairment that cannot be corrected with glasses or contact lenses (excluding colour-blindness)
* Smoke tobacco or vape nicotine or use nicotine replacement products (occasional social smoking is permitted)
* Have relevant food intolerances/ sensitivities/ allergies
* 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 are taken are out of choice and are not medically prescribed or advised). Existing and consistent use of vitamin D supplements and protein shakes are permitted
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT05544500
Study Brief:
Protocol Section:
NCT05544500