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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorPanhellenic Federation of Alzheimer's Disease and Related Disorders

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Low-Dose Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement
  • High-Dose Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement
  • Placebo

Treatment groups

141 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Panhellenic Federation of Alzheimer's Disease and Related Disorders

Lead sponsor

Palliative Care Centre "Panagia Glykofilousa", Greek Association of Alzheimer's Disease and Related Disorders, Plastira 65, Thessaloniki 542 50, Greece.

Collaborator

Levius Vita Foods srl

Collaborator