- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04787497
The Effect of Extra Virgin Olive Oil in People With Multiple Sclerosis
October 31, 2023 updated by: Maria Loizou, University of Cyprus
The Neuropsychological Effects of Extra-Virgin Olive Oil in People With Multiple Sclerosis
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Maria Loizou
- Phone Number: 0035796651493
- Email: loizou.g.maria@ucy.ac.cy
Study Locations
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Thessaloniki, Greece
- Private medical office
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group
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.
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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.
|
No Intervention: Control Group
The Control Group will be continuing their standard medical treatment without additional supplementation.
The neuropsychological assessment will be conducted at baseline, 6 months and 12 months +/- 7 days after their first assessment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symbol Digits Modalities Test (SDMT)
Time Frame: 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.
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baseline, 6-months, 12-months
|
California Verbal Learning Test-Second Edition (CVLT-II)
Time Frame: 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.
|
baseline, 6-months, 12-months
|
Brief Visuospatial Memory Test-Revised (BVMT-R)
Time Frame: 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.
|
baseline, 6-months, 12-months
|
Wisconsin Card Sorting Test (WCST)
Time Frame: 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.
|
baseline, 6-months, 12-months
|
Trail Making Test (TMT)
Time Frame: 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.
|
baseline, 6-months, 12-months
|
The Vocabulary and Block Design from the Wechsler Adult Intelligence Scale (WAIS)
Time Frame: baseline
|
It will provide an estimated intelligence quotient (IQ) score
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baseline
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The Digit Span Test (DST) from WAIS
Time Frame: 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.
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baseline, 6-months, 12-months
|
Word List Generation (WLG) Test
Time Frame: 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.
|
baseline, 6-months, 12-months
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Faux Pas Recognition (FPR) Test
Time Frame: 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.
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baseline, 6-months, 12-months
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Hospital Anxiety and Depression Scale (HADS)
Time Frame: baseline, 6-months, 12-months
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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.
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baseline, 6-months, 12-months
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Health Status Questionnaire (SF-36)
Time Frame: 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.
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baseline, 6-months, 12-months
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Modified Fatigue Impact Scale (MFIS)
Time Frame: 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.
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baseline, 6-months, 12-months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
September 1, 2024
Study Registration Dates
First Submitted
March 1, 2021
First Submitted That Met QC Criteria
March 5, 2021
First Posted (Actual)
March 8, 2021
Study Record Updates
Last Update Posted (Actual)
November 2, 2023
Last Update Submitted That Met QC Criteria
October 31, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEEVOO.MS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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