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 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT05504668
Eligibility Criteria:
Inclusion Criteria:
* 55-75 years at time of enrolment
* Answers yes to the question 'would you say that your memory now is worse now than it used to be in your 20's?'
Exclusion Criteria:
* Pre-existing medical condition/illnesses which would impact taking part in the study The explicit exceptions to this were controlled (medicated) arthritis, asthma, hay fever, high cholesterol and reflux-related conditions. Other, unforeseen, exceptions were considered on a case-by-case basis; i.e. participants may have progressed to screening if they had a condition/illness which would not interact with the active treatments or impede performance.
* Currently taking prescription medications The explicit exceptions to this were contraceptive and hormone replacement treatments for female participants where symptoms were stable and treatment would 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 have been other instances of permitted medication use where no interaction with the active treatments was anticipated.
* High blood pressure (BP; systolic over 159 mm Hg or diastolic over 99 mm Hg)
* Body Mass Index (BMI) outside of the range 18.5-30 kg/m2
* Pregnant, seeking to become pregnant or lactating
* Learning and/or behavioural difficulties such as dyslexia or Attention Deficit Hyperactivity Disorder (ADHD)
* Visual impairments not corrected with glasses or contact lenses (including colour-blindness)
* Smoking (including vaping)
* Excessive caffeine intake (\>500 mg per day)
* Clinically diagnosed food intolerances/sensitivities
* Antibiotic, prebiotic or probiotic (including drinks; e.g. Yakult or Actimel) use within the past 8 weeks
* Health conditions preventing fulfilment of the study requirements (this included non-diagnosed conditions for which no medication was taken)
* Inability to complete all of the study assessments
* Currently participating in other clinical or nutrition intervention studies, or had in the past 4 weeks (8 weeks if a probiotic study)
* Diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months
* Diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months
* Suffering 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
75 Years
Study:
NCT05504668
Study Brief:
Protocol Section:
NCT05504668