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

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.

Conditions

• Mild Cognitive Impairment (MCI)

Interventions

DIETARY_SUPPLEMENT

Low-Dose Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement

This is a prospective, randomised, double-blind, three-arm, placebo-controlled with 1:1:1 randomisation and 52-week follow-up trial. The MEDIPHENO-HTrial study will enrol patients within the Mild Cognitive Impairment spectrum related to AD and non-AD type pathologies. Participants will be randomised to receive either 8 drops of the active HT-high phenolic supplement, or 16 drops of the active HT-high phenolic supplement or 8 drops of the matching placebo. The Mediterranean diet adherence support will be delivered identically to all groups to reduce dietary confounding.

DIETARY_SUPPLEMENT

High-Dose Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement

This is a prospective, randomised, double-blind, three-arm, placebo-controlled with 1:1:1 randomisation and 52-week follow-up trial. The MEDIPHENO-HTrial study will enrol patients within the Mild Cognitive Impairment spectrum related to AD and non-AD type pathologies. Participants will be randomised to receive either 8 drops of the active HT-high phenolic supplement, or 16 drops of the active HT-high phenolic supplement or 8 drops of the matching placebo. The Mediterranean diet adherence support will be delivered identically to all groups to reduce dietary confounding.

DIETARY_SUPPLEMENT

Placebo

This is a prospective, randomised, double-blind, three-arm, placebo-controlled with 1:1:1 randomisation and 52-week follow-up trial. The MEDIPHENO-HTrial study will enrol patients within the Mild Cognitive Impairment spectrum related to AD and non-AD type pathologies. Participants will be randomised to receive either 8 drops of the active HT-high phenolic supplement, or 16 drops of the active HT-high phenolic supplement or 8 drops of the matching placebo. The Mediterranean diet adherence support will be delivered identically to all groups to reduce dietary confounding.

Sponsors & Collaborators

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

  collaborator UNKNOWN

• Levius Vita Foods srl

  collaborator UNKNOWN

• Panhellenic Federation of Alzheimer's Disease and Related Disorders

  lead OTHER

Principal Investigators

• Vilma Chalili · School of Medicine, Aristotle University of Thessaloniki

• Magda Tsolaki · First Department of Neurology, Faculty of Health Sciences, School of Medicine, Aristotle University of Thessaloniki

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-31

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• Greece

Study Locations