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

Study acronym: MeDi-SUPOL
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 years 5 months later Apr 30, 2026 → Sep 30, 2029
See other at-risk trials from Aristotle University Of Thessaloniki

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Apr 30, 2026 to Sep 30, 2029 Show 8 more changesShow less
    • Enrollment reopened
    • Start date: Nov 1, 2024 to Jan 31, 2025
    • Study completion pushed from Nov 1, 2026 to Nov 30, 2029
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints: details revised at 2 of 13 entries
    • Study description expanded, about 155 words
    • Site details revised at 2 of 2 sites
    • Collaborators: 3 to 4
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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: Double Blind (Subject, Outcome Assessor - Investigator) on Supplement, Primary Purpose: Prevention.
Trial Details
NCT Number NCT06705738
Lead Sponsor Aristotle University Of Thessaloniki
Collaborators: Greek Alzheimer's Association and Related Disorders, University of Glasgow, World Olive Center for Health, National and Kapodistrian University of Athens
Conditions
(from sponsor)		 Mild Cognitive Impairment
Related terms Alzheimer Disease, Cognitive Dysfunction
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov