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Life sciences · Interventional Study
ClinicalTrials.gov · October 7, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06705738). This is a study registration, not published results. Lead sponsor: Aristotle University Of Thessaloniki. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 200 participants (ESTIMATED). Conditions: Mild Cognitive Impairment. Interventions: DIETARY_SUPPLEMENT: SUPOL; OTHER: Dietary Pattern: MeDi. Primary outcome measures: ADAS-Cog - Measurement to Assess the Severity of Cognitive Impairment , Baseline (Day 1) to 12 months; MMSE - Measurement to Assess and Evaluate Cogntive Function , Baseline (Day 1) to 12 months. Brief 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: Double Blind (Subject, Outcome Assessor - Investigator) on Supplement, Primary Purpose: Prevention.