Hydroxytyrosol-rich olive polyphenol with the Mediterranean diet for cognitive health in adults with mild cognitive impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study explores the cognitive effects of combining a hydroxytyrosol-rich olive juice polyphenol supplement with adherence to a Mediterranean diet in individuals with mild cognitive impairment. Participants are randomized to receive either low-dose or high-dose hydroxytyrosol-rich olive juice polyphenol supplement or a placebo, all alongside the Mediterranean dietary pattern. The trial aims to see if this polyphenol-rich intervention can slow cognitive decline compared with placebo within the context of MeDi adherence. Outcomes will consider cognitive performance and related biomarkers in the mild cognitive impairment population. The study is conducted under the auspices of Greek institutions with multiple collaborating organizations.

Why it matters

Who can join: the full rules

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.
* Neurologic conditions such as vascular dementia, movement disorders, history of conditions such as anaemia and cancer in the last five years, renal or liver failure, malignant tumours, or organ transplant.
* Coffee consumption greater than 5 cups per day.
* Body mass index \> 35 kg/ m2.
* Not taking a stable dose of statins for at least 3 months before the recruitment visit. Taking antibiotics in the 1 week preceding the recruitment visit.
* Pregnancy or lactation.
* Participation in another clinical trial during the last 30 days prior to the recruitment visit.
* Subject taking supplements that may affect lipoprotein metabolism, \>1 g of fish oil/day, antioxidant supplements, cannabidiol (CBD) oil.

Where it's running

• Palliative Care Centre "Panagia Glykofilousa", Greek Association of Alzheimer's Disease and Related Disorders, Plastira 65, Thessaloniki 54250, Greece.
  Thessaloniki, Central Macedonia, Greece Recruiting

Study contacts

• Principal investigator: Vilma Chalili — School of Medicine, Aristotle University of Thessaloniki
• Study coordinator: Magda Tsolaki, Professor Emeritus, MD, PhD
• Email: tsolakim1@gmail.com
• Phone: +30 2310316143

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.