The Effect of Combination of Mediterranean Diet and Oleocanthal in Patients with Mild Cognitive Impairment

Summary

BACKGROUND: Mild cognitive impairment (MCI) constitutes a form of preclinical dementia and characterizes a cognitive decline that exceeds what is expected for one's age and education status, but at the same time does not fulfill the criteria for dementia. MCI is considered a prodromal stage of Alzheimer's disease (AD) and the progression to this neurodegenerative disease, renders the patients heavily dependent on their relatives and the society, which creates a huge psychological and financial burden, since no effective treatment exists for MCI and AD to this day. Mediterranean diet (MeDi) displays beneficial effects on the cognitive function of both healthy individuals and cognitive impaired patients. High Phenolic Early Harvest Extra Virgin Olive Oil (HP-EH-EVOO) is a natural product that contains high concentrations of the substance Oleocanthal (OLC), while at the same time it has been shown to exert beneficial properties on the cognitive function of cognitive impaired individuals, as well as on the slowing down of the decline of cognitive function.

AIM: The main hypothesis that will be evaluated is whether the combined approach of the MeDi pattern and the concurrent intervention with the administration in a capsule form of the supplement containing olive oil polyphenols with the main substance being Oleocanthal (SUPOL), could constitute a considerable strategy of management of MCI patients.

Study Type: Investigational Study Design, Allocantion: Randomized Intervention Model, Parallel Assignment Masking: Single Blind (Outcome Assessor - Investigator) on Diet, Double Blind (Subject, Outcome Assessor - Investigator) on Supplement, Primary Purpose: Prevention.

Conditions

• Mild Cognitive Impairment

Interventions

DIETARY_SUPPLEMENT

SUPOL

Supplement containing Olive Oil Polyphenol with the main substance being Oleocanthal (SUPOL), 2 capsules twice a day (4 capsules total) for 12 months.

OTHER

Dietary Pattern: MeDi

Adherance to Mediterranean dietary pattern to be followed for 12 months.

Sponsors & Collaborators

• Greek Alzheimer's Association and Related Disorders

  collaborator OTHER

• University of Glasgow

  collaborator OTHER

• World Olive Center for Health

  collaborator UNKNOWN

• Aristotle University Of Thessaloniki

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-01

Primary Completion

2026-04-30

Completion

2026-11-01

Countries

• Greece

Study Locations