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

NCT ID: NCT04787497

Last Updated: 2023-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

High Phenolic Extra Virgin Olive Oil

Intervention Type DIETARY_SUPPLEMENT

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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World Olive Center for Health

UNKNOWN

Sponsor Role collaborator

Ellis-Farm, Eliama Daily Value

UNKNOWN

Sponsor Role collaborator

University of Cyprus

OTHER

Sponsor Role lead

Responsible Party

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Maria Loizou

Clinical Psychology Doctorate Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Private medical office

Thessaloniki, , Greece

Site Status

Countries

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Greece

Other Identifiers

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NEEVOO.MS

Identifier Type: -

Identifier Source: org_study_id

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