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 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT03679533
Eligibility Criteria:
Inclusion Criteria:
* Aged between 50 and 80 years old.
* Willing and able to provide written informed consent.
* Fluent in written and spoken English.
* Normal or corrected to normal vision and hearing.
* Understands and is willing and able to comply with all study procedures.
Exclusion Criteria:
* Diagnosis of any form of dementia or significant neurological condition.
* Significant memory complaints.
* Past history or MRI evidence of brain damage, including significant trauma, stroke, learning difficulties or serious neurological disorder, including a loss of consciousness for more than 24 hours.
* Currently smoking or ceased smoking less than 6 months ago.
* Chronic fatigue syndrome, liver disease, diabetes mellitus, or gall bladder abnormalities.
* History of alcohol or drug dependency.
* Clinically diagnosed psychiatric disorder.
* Existing diagnosed gastrointestinal disorders likely to impact on absorption of flavonoids.
* Known allergy to the intervention supplement.
* Any significant medical condition likely to affect participation.
* Currently a participant or have been a participant in any other study involving an investigational product within the last 4 weeks.
* Uncontrolled hypertension (systolic blood pressure \>140mmHg, diastolic blood pressure \>90mmHg).
* Major cardiovascular event, such as myocardial infarction, within the last 12 months.
* On a stable prescription of blood pressure lowering medication or non-steroidal anti-inflammatory drugs. for fewer than 2 months.
* Prescribed anti-coagulant/blood thinning medication (eg. warfarin).
* Taking flavonoid containing supplements (and unwilling to cease intake during, and 1 month preceding the trial) or unwilling to maintain existing intake of other supplements.
* High flavonoid intake defined as \> 15 portions of flavonoid rich foods per day
* Are currently taking medication or supplements which have a significant impact on the outcome measures.
In addition, any participants with claustrophobia will not be invited to participate in the neuroimaging component of the study. Likewise for metal implants, e.g. pacemaker that precludes MRI.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT03679533
Study Brief:
Protocol Section:
NCT03679533