NCT07672938 · RECRUITING

Effects of Hydroxytyrosol-Rich Olive Polyphenol Dietary Supplement Combined With Mediterranean Diet Adherence on the Cognitive Health of Patients With Mild Cognitive Impairment

This trial is testing whether a daily olive polyphenol supplement rich in hydroxytyrosol, taken at a low or high dose and alongside a Mediterranean diet, protects thinking and memory in people with mild cognitive impairment. It is compared with a placebo. It is not a drug phase trial, so it is an early look, not proof.

You may qualify if

  • 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

You're excluded if

  • 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.

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 2026-06-30

View full record on ClinicalTrials.gov

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