NCT03679533 · COMPLETED
The Impact of Cranberries On the Microbiome and the Brain in Healthy Ageing sTudy (COMBAT)
This trial is testing whether eating freeze-dried cranberry powder twice daily for 12 weeks improves memory and brain health in people aged 50 to 80 with no memory complaints. Researchers will also look at whether cranberries change gut bacteria, and whether those changes connect to brain function measured by cognitive tests and MRI scans. This is a Phase NA dietary supplement study — exploratory work, not a drug trial, and not yet proven to prevent any disease.
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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2020-09-30