Global Journal of Medical Research, L: Nutrition & Food Science, Volume 22 Issue 2

b) Procedure All study participants read the information sheet and signed an informed consent stating that the research group have the permission to use their demographic data, which would be anonymized, such as gender, age and education, as well as their performance in the neuropsychological tests, for research purposes. Before the administration of EH EVOO, the participants were evaluated using an extended neuropsychological assessment which includes measurements that cover a wide range of cognitive functions and are mentioned below. The neuropsychological assessment took place in a soundproof room in 1 st Department of Neurology of Aristotle University of Thessaloniki in Greece by a trained psychologist. Patients were instructed to take three tablespoons of EH EVOO per day. After six months and after one year they were called in for re-evaluation, using the same measurements but with alternative forms, wherever it was possible. The protocol of the present study is registered ClinicalTrials.gov with ID NCT04120675. The EH EVOO, which was distributed to the participants, is Eliama D. V. Gold Health Claim High Phenolic Extra Virgin Olive Oil and contains high concentrations of polyphenol compounds (Oleocanthal, Oleacein, Oleuropein, Tyrosol & Hydroxytyrosol derivatives > 1200 mg /kg EVOO and very high concentration of Squalene 6800 mg and Tocoferol a). Eliama Daily Value Gold brings the certification of Health Claim. The health claim: The claim may be used only for olive oil which contains at least 5 mg of hydroxytyrosol and its derivatives (e.g. oleuropein complex and tyrosol) per 20g of EVOO. In order to bear the claim information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 20g of EVOO et least. “According to European Regulation 432/2012 (L136/25.5.2012 p. 26), the Health Claim is brought only by the olive oil that contains at least 250gr. polyphenols per 1Kg. of olive oil. A chemical analysis of the product was done by an approved chemical lab, but also the polyphenols analysis from the Pharmacology Department of National Kapodistrian University of Athens. c) Neuropsychological examination 1. The Frontal Assessment Battery (FAB) consists of 6 tasks and evaluates frontal deficits. These tasks can disclose deficits in conceptualization (similarity test), mental flexibility (lexical fluency), motor programming (Luria’s fist-edge-palm, conflicting instructions, Go/ No go tests) and environmental autonomy (prehension behavior). So, it was useful in order to evaluate cognitive deficits which may have occurred due to frontotemporal lesions. The mean score for MS patients is 16.8 (SD=2) [14]. 2. The Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) is a neuropsychological battery which has been validated in the Greek MS population and consists of the Symbol Digit Modalities Test (SDMT), the California Verbal Learning Test (CVLT) and the Brief Visuospatial Memory Test-Revised (BVMT-R) [15]. SDMT is used to detect deficits in visual processing speed. It consists of a series of nine symbols, each in association with a single digit. Participants enunciate the digit related to each symbol in a randomized sequence, as fast as they can, in a 90 seconds session. The total score is derived from the number of correct answers enunciating the digit related to each symbol in a randomized sequence, as fast as they can, in 90 s. Instead of the CVLT, the Greek adaption of this test (GVLT) was used in order to measure auditory and verbal memory. Participants have to learn as many words as they can from a list with 16 words and this procedure is repeated five times. Form A was used for the assessment and form B for the retesting session. The total score equals to the total number of recalled words [16]. BVMT-R measures visual and spatial memory. In this test, participants must remember a page of six shapes which is presented for ten seconds and this procedure is repeated three times. Each shape is scored with zero, one or two points, depending on accuracy and location. The sum of the scores of the three trials is the total score of the test. [17]. 3. The Perceived Deficits Questionnaire is a self- reporting questionnaire measuring subjective cognitive deficits and is designed specifically for MS patients. It covers the cognitive functions which are most often impaired in MS and it concludes four subscales: attention, retrospective memory, prospective memory and planning/organizing. The total score is computed by the sum of raw scores for all items and it can range from 0-80, with higher scores indicating greater perceived cognitive impairment [18]. 4. The Mental Health Inventory (MHI) is a reliable measure for patients’ emotional condition. It consists of 18 items which are separated in four scales: anxiety, depression, behavioral control and positive affect. The total scores range from 0-100, with higher scores indicating better mental health [19]. 5. The Beck Depression Inventory (BDI) is used to measure depression. It is designed to examine both somatic and cognitive aspects of depression and the Greek version has been validated previously [20] and has been widely used to date. The BDI is a 21-item self-reporting scale scored on a 4-point 47 Year 2022 Global Journal of Medical Research Volume XXII Issue II Version I ( D ) L © 2022 Global Journals The Effects of Early-Harvest Extra Virgin Olive Oil on Cognition and Mental Health of Primary (PPMS) or Secondary (SPMS) Progressive Multiple Sclerosis Patients