The Effect of Extra Virgin Olive Oil in People With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

The Neuropsychological Effects of Extra-Virgin Olive Oil in People With Multiple Sclerosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04787497
• Other study ID #: NEEVOO.MS
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: University of Cyprus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: September 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Dietary Supplement:
• High 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.

Locations

Country	Name	City	State
Greece	Private medical office	Thessaloniki

Sponsors (3)

Lead Sponsor	Collaborator
University of Cyprus	Ellis-Farm, Eliama Daily Value, World Olive Center for Health

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symbol Digits Modalities Test (SDMT)	Change will be assessed in the SDMT score (0-100 range), over three time points. Higher score indicates better processing speed.	baseline, 6-months, 12-months
Primary	California Verbal Learning Test-Second Edition (CVLT-II)	Change will be assessed in the CVLT-II score (0-80 range), over three time points. Higher score indicates better auditory-verbal learning.	baseline, 6-months, 12-months
Primary	Brief Visuospatial Memory Test-Revised (BVMT-R)	Change will be assessed in the BVMT-R score (0-36 range), over three time points. Higher score indicates better visuospatial memory.	baseline, 6-months, 12-months
Primary	Wisconsin Card Sorting Test (WCST)	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.	baseline, 6-months, 12-months
Primary	Trail Making Test (TMT)	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.	baseline, 6-months, 12-months
Primary	The Vocabulary and Block Design from the Wechsler Adult Intelligence Scale (WAIS)	It will provide an estimated intelligence quotient (IQ) score	baseline
Primary	The Digit Span Test (DST) from WAIS	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.	baseline, 6-months, 12-months
Primary	Word List Generation (WLG) Test	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.	baseline, 6-months, 12-months
Primary	Faux Pas Recognition (FPR) Test	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.	baseline, 6-months, 12-months
Primary	Hospital Anxiety and Depression Scale (HADS)	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.	baseline, 6-months, 12-months
Primary	Health Status Questionnaire (SF-36)	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.	baseline, 6-months, 12-months
Primary	Modified Fatigue Impact Scale (MFIS)	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.	baseline, 6-months, 12-months