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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Greece
      • Thessaloniki, Greece
        • Private medical office

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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
baseline
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.
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
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.
baseline, 6-months, 12-months
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 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.
baseline, 6-months, 12-months
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.
baseline, 6-months, 12-months
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.
baseline, 6-months, 12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Cyprus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
World Olive Center for Health
Ellis-Farm, Eliama Daily Value

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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