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:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-24 @ 7:21 PM
NCT ID:
NCT03695003
Eligibility Criteria:
Inclusion Criteria:
* Participants must self-assess themselves as being in good health.
* Aged 30 to 60 years at the time of giving consent
* In daytime employment and/or higher education
Exclusion Criteria:
* Have any pre-existing medical condition/illness which will impact taking part in the study NOTE: the explicit exceptions to this are controlled (medicated) arthritis, asthma, hay fever, high cholesterol and reflux-related conditions. There may be other, 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 exceptions to this are contraceptive and hormone replacement treatments for female participants where symptoms are stable and treatment will not change during the course of the study, those medications used in the treatment of arthritis, high cholesterol and reflux-related conditions; and those taken 'as needed' in the treatment of asthma and hay fever. As above, there may be other instances of medication use which, where no interaction with the active treatments is likely, participants may be able to progress to screening.
* Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
* Have a Body Mass Index (BMI) outside of the range 18.5-30 kg/m2
* Are pregnant, seeking to become pregnant or lactating
* Have learning and/or behavioural difficulties such as dyslexia or ADHD
* Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness)
* Smoker
* excessive caffeine intake (\>500 mg per day)
* Have food intolerances/ sensitivities
* Have taken antibiotics, prebiotics or probiotics (including drinks. Eg. Yakult or Actimel) within the past 8 weeks
* Have any health condition that would prevent fulfillment 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 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 disturbances (including night-shift work) and/ or are taking sleep aid medication
* Any known active infections
* Does not have a bank account (required for payment)
* Are non-compliant with regards treatment consumption (see 4.3)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
60 Years
Study:
NCT03695003
Study Brief:
Protocol Section:
NCT03695003