The Effect of Extra Virgin Olive Oil in People With Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Dietary Supplement: High Phenolic Extra Virgin Olive Oil
- Registration Number
- NCT04787497
- Lead Sponsor
- University of Cyprus
- Brief Summary
This is an open label feasibility trial to examine the effect of a complementary treatment with High Phenolic Extra Virgin Olive Oil (HPEVOO) on the cognitive and mental health of people with Multiple Sclerosis (MS), while receiving their standard medical treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 46
- Clinical diagnosis of MS
- Must be between 18 to 65 years of age
- Both males and females are eligible for participation
- Must have at least five years of education
- Must be fluent in Greek language
- Other neurological, psychiatric or chronic condition
- Enrollment in other trials/drug studies
- Experiencing side effects from previous treatments
- Inadequate visual and auditory acuity
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Group High Phenolic Extra Virgin Olive Oil The Experimental Group will be receiving 50ml of freshly, cold-pressed, oleocanthal-rich Extra Virgin Olive Oil (EVOO) alongside their prescribed medical treatment. EVOO will be consumed on a daily basis for 12 months and all participants will undergo a neuropsychological assessment at baseline, 6 months and 12 months +/- 7 days after their first assessment or beginning of supplementation.
- Primary Outcome Measures
Name Time Method Symbol Digits Modalities Test (SDMT) baseline, 6-months, 12-months Change will be assessed in the SDMT score (0-100 range), over three time points. Higher score indicates better processing speed.
Wisconsin Card Sorting Test (WCST) baseline, 6-months, 12-months Change will be assessed in the WCST score over three time points. WCST examines attention, working memory and intellectual flexibility (0-64 score range). Higher scores represent worse performance.
Hospital Anxiety and Depression Scale (HADS) baseline, 6-months, 12-months Change will be assessed in the HADS scores over three time points. HADS examines anxiety, depression and psychological distress. Higher scores (0-42 range) indicate greater levels of anxiety and depression.
Health Status Questionnaire (SF-36) baseline, 6-months, 12-months Change will be assessed in SF-36 scores over three time points. SF-36 consists of eight scales (0-100 score range each) that examine physical and mental health-related quality of life. The lower the score the more disability.
Brief Visuospatial Memory Test-Revised (BVMT-R) baseline, 6-months, 12-months Change will be assessed in the BVMT-R score (0-36 range), over three time points. Higher score indicates better visuospatial memory.
The Vocabulary and Block Design from the Wechsler Adult Intelligence Scale (WAIS) baseline It will provide an estimated intelligence quotient (IQ) score
Faux Pas Recognition (FPR) Test baseline, 6-months, 12-months Change will be assessed in the FPR score over three time points. FPR examines social cognition. Four different vignettes will be used for every assessment (0-20 score range). Higher scores indicate better performance.
Modified Fatigue Impact Scale (MFIS) baseline, 6-months, 12-months Change will be assessed in the MFIS score over three time points. MFIS examines how often fatigue interferes with daily activities. Higher scores (0-84 score range) indicate greater impact of fatigue on a person's activities.
California Verbal Learning Test-Second Edition (CVLT-II) baseline, 6-months, 12-months Change will be assessed in the CVLT-II score (0-80 range), over three time points. Higher score indicates better auditory-verbal learning.
Trail Making Test (TMT) baseline, 6-months, 12-months Change will be assessed in the TMT scores over three time points. TMT examines attention, intellectual flexibility and inhibition. Longer time to completion indicates worse performance.
The Digit Span Test (DST) from WAIS baseline, 6-months, 12-months Change will be assessed in the DST score over three time points. DST examines working memory, 0-48 score range, higher scores indicate better working memory function.
Word List Generation (WLG) Test baseline, 6-months, 12-months Change will be assessed in the WLG score over three time points. WLG examines lexical fluency. The higher the number of words generated, the better is the performance.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Private medical office
🇬🇷Thessaloniki, Greece