Multiple Sclerosis
Conditions
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.
Interventions
DIETARY_SUPPLEMENTHigh Phenolic Extra Virgin Olive Oil
Participants will be assigned in two groups: the Experimental Group (N= 20) will be receiving 50ml of freshly, cold-pressed, oleocanthal-rich Extra Virgin Olive Oil (EVOO) alongside their prescribed medical treatment, whereas the Control Group (N = 20) will be receiving their medical treatment as usual. The Experimental Group will be receiving the complementary treatment 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 treatment.
Sponsors
World Olive Center for Health
Ellis-Farm, Eliama Daily Value
University of Cyprus
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Other neurological, psychiatric or chronic condition * Enrollment in other trials/drug studies * Experiencing side effects from previous treatments * Inadequate visual and auditory acuity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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 Vocabulary and Block Design from the Wechsler Adult Intelligence Scale (WAIS) | baseline | It will provide an estimated intelligence quotient (IQ) score |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Greece
Outcome results
None listed