Effects Of Hydroxytyrosol-Rich Olive Polyphenol Dietary Supplement Combined With Mediterranean Di… (NCT07672938) | Clinical Trial Compass
RecruitingNot Applicable
Effects Of Hydroxytyrosol-Rich Olive Polyphenol Dietary Supplement Combined With Mediterranean Diet Adherence on the Cognitive Health of Patients With Mild Cognitive Impairment.
Greece141 participantsStarted 2025-03-31
Plain-language summary
Nutrition is an important modifiable risk factor of human cognitive health. Increasing data suggests that certain nutrients or food ingredients, such as plant polyphenols, have the potential to benefit cognitive abilities even in later life. In terms of polyphenols, Hydroxytyrosol (HT) has gained health benefit claims as a potential preventative antioxidant supplementation of neurodegenerative and amyloid-associated diseases while its pharmacological mechanisms suggest protection against cognitive decline. The primary objective of this study will be to evaluate the effects of HT-rich olive juice polyphenol supplementation alongside MeDi adherence compared with placebo alongside MeDi adherence in the prevention of cognitive decline among patients with Mild Cognitive Impairment associated with AD and non-AD pathology.
Who can participate
Age range
50 Years – 85 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:
* GR-based men and women aged 50 - 85
* Willingness and ability to conform to the full protocol.
* Ability to accept and sign the consent form.
* Presence of a diagnostic classification of Mild Cognitive Impairment according to the National Institute on Aging and Alzheimer's Association (NIA-AA) framework MCI, which corresponds to stage 3 on the pre-dementia range.
* MoCA score of ≥18 and ≤ 26. Or
* MMSE (Mini-Mental State Examination) score of ≥26 and ≤ 28.
* No active suicide ideation based on the Columbia-Suicide Severity Rating Scale.
* Absence of severe depressive symptomatology based on the Geriatric Depression Scale-15.
* Not using any laxative drugs for at least three days prior to the screening visit.
* Information about APOE status
Exclusion Criteria:
* Patients with mild, moderate, or severe dementia.
* Current or recent (within the last 4 weeks) engagement with a strict dietary regime i.e., vegetarian / vegan / ketogenic / paleolithic / high protein / weight loss.
* Any known issues with blood taking.
* Any known bleeding disorders.
* Any known allergy to olives, inability to tolerate gluten or multiple allergies/intolerances that would significantly limit food intake.
* Average alcohol use of \>21 glasses per week for men and \>14 glasses per week for women (on average for the last six months).
* History of psychiatric illness including intellectual disability, schizophrenia, bipolar disorder, severe, active depression and alcoholism.
* Neu…
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.
What they're measuring
1
Primary: Mean change on the Alzheimer's Disease (AD) Assessment Scale-Cognitive Subscale (ADAS-Cog) total score from baseline to Week 52 compared with placebo
Timeframe: From baseline to Week 52
Trial details
NCT IDNCT07672938
SponsorPanhellenic Federation of Alzheimer's Disease and Related Disorders