Effect of Polyphenol-rich Cocoa Products on Cognitive Function (NCT02996578) | Clinical Trial Compass
CompletedNot Applicable
Effect of Polyphenol-rich Cocoa Products on Cognitive Function
United Kingdom16 participantsStarted 2017-04-17
Plain-language summary
This project aims to investigate whether consumption of cocoa polyphenols has an impact on cognitive function in individuals aged 50 to 60 years of age and if such an improvement is a result of an improvement in risk factors associated with cognitive decline in ageing.
Who can participate
Age range
50 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males \& Females aged 50-60years of age with normal or corrected to normal vision
* BMI cut off points of ≥18.5 to ≤29.9 kg/m2
* Waist circumference smaller than 102cm for males \& smaller than 88cm for women
* Blood pressure of ≥ 90 over 60 and ≤ 120 over 80
* MoCA test score ≥ 26
Exclusion Criteria:
* Allergies to cocoa or any other ingredients commonly found in cocoa confectionary eg: milk, nuts, soya
* Smoker
* Women who are new or expecting mothers, maybe or are currently pregnant and/or breastfeeding
* Taking medications for chronic conditions including (but not limited to) diabetes, heart disease, hypertension
* No previous history of stroke, brain trauma and other head-related injuries
* No diagnosis of depression and/or anxiety
* No previous cancer diagnosis
* Taking antibiotics
* Taking steroids and non-steroidal anti-inflammatory drugs (NSAIDS)
* Women on Hormone Replacement Therapy (HRT)
* Taking medication that can cause drowsiness or affect cognitive functioning
* Taking polyphenol supplements including (but not limited to) green tea extract, acai berry extract
* Taking soy/a supplements
* History of alcohol misuse
* Fear of needles and/or fainting when blood is taken
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.