The Effect of Combination of Mediterranean Diet and Oleocanthal in Patients With Mild Cognitive Impairment
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.
⁃ Participants are eligible to be included in this study only if all the following criteria apply:
• Men or women,
• 60 to 85 years of age inclusive, at the time of signing the informed consent form (ICF).
• Mini-Mental State Examination (MMSE) score of 26-28 at Screening (Visit 1).
• Montreal Cognitive Assessment (MoCA) score of 20-26 at Visit 1.
• MRI scan evaluation at Visit 1.
• CSF biomarkers evaluation at Visit 1.
• Adequate knowledge and understanding of the Greek language, as well as adequate literacy, vision and hearing for neuropsychological testing in the opinion of the Principal Investigator (PI) at the time of screening.
• They are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.