The Effect of Extra Virgin Olive Oil in People With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
High Phenolic Extra Virgin Olive Oil
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple Sclerosis
Eligibility Criteria
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
Sites / Locations
- Private medical officeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental Group
Control Group
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
The Vocabulary and Block Design from the Wechsler Adult Intelligence Scale (WAIS)
It will provide an estimated intelligence quotient (IQ) score
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04787497
First Posted
March 1, 2021
Last Updated
May 9, 2023
Sponsor
University of Cyprus
Collaborators
World Olive Center for Health, Ellis-Farm, Eliama Daily Value
1. Study Identification
Unique Protocol Identification Number
NCT04787497
Brief Title
The Effect of Extra Virgin Olive Oil in People With Multiple Sclerosis
Official Title
The Neuropsychological Effects of Extra-Virgin Olive Oil in People With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cyprus
Collaborators
World Olive Center for Health, Ellis-Farm, Eliama Daily Value
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this clinical trial is 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
High Phenolic Extra Virgin Olive Oil
Intervention Description
Participants will be randomly assigned in two groups: the Experimental Group (N= 50) will be receiving 50ml of freshly, cold-pressed, oleocanthal-rich EVOO alongside their prescribed medical treatment, whereas the Control Group (N = 50) 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.
Primary Outcome Measure Information:
Title
Symbol Digits Modalities Test (SDMT)
Description
Change will be assessed in the SDMT score (0-100 range), over three time points. Higher score indicates better processing speed.
Time Frame
baseline, 6-months, 12-months
Title
California Verbal Learning Test-Second Edition (CVLT-II)
Description
Change will be assessed in the CVLT-II score (0-80 range), over three time points. Higher score indicates better auditory-verbal learning.
Time Frame
baseline, 6-months, 12-months
Title
Brief Visuospatial Memory Test-Revised (BVMT-R)
Description
Change will be assessed in the BVMT-R score (0-36 range), over three time points. Higher score indicates better visuospatial memory.
Time Frame
baseline, 6-months, 12-months
Title
Wisconsin Card Sorting Test (WCST)
Description
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.
Time Frame
baseline, 6-months, 12-months
Title
Trail Making Test (TMT)
Description
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.
Time Frame
baseline, 6-months, 12-months
Title
The Vocabulary and Block Design from the Wechsler Adult Intelligence Scale (WAIS)
Description
It will provide an estimated intelligence quotient (IQ) score
Time Frame
baseline
Title
The Digit Span Test (DST) from WAIS
Description
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.
Time Frame
baseline, 6-months, 12-months
Title
Word List Generation (WLG) Test
Description
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.
Time Frame
baseline, 6-months, 12-months
Title
Faux Pas Recognition (FPR) Test
Description
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.
Time Frame
baseline, 6-months, 12-months
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
baseline, 6-months, 12-months
Title
Health Status Questionnaire (SF-36)
Description
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.
Time Frame
baseline, 6-months, 12-months
Title
Modified Fatigue Impact Scale (MFIS)
Description
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.
Time Frame
baseline, 6-months, 12-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Loizou
Phone
0035796651493
Email
loizou.g.maria@ucy.ac.cy
Facility Information:
Facility Name
Private medical office
City
Thessaloniki
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magda Tsolaki
Email
tsolakim1@gmail.com
12. IPD Sharing Statement
Learn more about this trial
The Effect of Extra Virgin Olive Oil in People With Multiple Sclerosis
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