Efficacy of Early Harvest Olive Oil in Cognition of Primary (PPMS) or Secondary (SPMS) Progressive Multiple Sclerosis

July 4, 2021 updated by: Magda Tsolaki, Aristotle University Of Thessaloniki

The Effects of Early Harvest Extra Virgin Olive Oil on Cognition and Mental Health of Primary (PPMS) or Secondary (SPMS) Progressive Multiple Sclerosis Patients

To date, no drug therapy has been approved for primary (PPMS) & secondary (SPMS) progressive multiple sclerosis. The urgent need to find new therapies - if possible with minimal side effects - led us to the search for the potential therapeutic effects of early harvest olive oil. The positive effect of phenol-rich, flavonoid and lignin-based olive oil on the modification of intestinal microbe populations and their by-products of metabolism is well known, such as the extent of gut-associated lymphoid tissue immune-stimulation due to antioxidants, anti-inflammatory and immunoregulatory properties. The aim of this Greek, Randomized Clinical Trial, is to evaluate the effect of Early Harvest Extra Virgin Olive Oil on cognition and mental health of patients diagnosed with PPMS or SPMS. The patients will be evaluated once at the beginning of treatment, after 6 months of treatment and after twelve months of treatment, in order to specify the eficacy of extra virgin olive oil in holistic treatments for SPMS and PPMS

Study Overview

Detailed Description

Study Type: Randomized Clinical Trial. Primary Purpose: Prevention OBJECTIVES OF THE TRIAL The objectives of this study are:To investigate the efficacy of Early Harvest EVOO as a disease course modifying treatment for primary (PPMS) or secondary (SPMS) progressive multiple sclerosis in a phase III randomized controlled clinical trial study in objective measurements in patients with primary (PPMS) or secondary (SPMS) progressive multiple sclerosis.

STUDY DESIGN This is a Greek, randomized controlled study group of Early Harvest EVOO to a control group, in which the patients will receive only their symptomatic medication. Qualifying patients will be randomly assigned to receive 50mL of Early Harvest EVOO or not on a daily basis for 24 months. Patients undergo assessments at baseline, 6 and 12 months +/- 7 days after beginning treatment.

Duration: The total study duration will be 12 months. Patients will receive study interventions for 12 months.

Number of Subjects 30 subjects total will be enrolled; 20 in the experimental group (Early Harvest EVOO); 10 in the Control group

Study Type

Interventional

Enrollment (Actual)

30

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 Locations

    • Macedonia
      • Thessaloniki, Macedonia, Greece, 546 36
        • A' Department of Neurology,Aristotle University of Thessaloniki (AUTH)

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of primary (PPMS) or secondary (SPMS) progressive multiple sclerosis
  • EDSS≥ 5
  • No response to any given treatment for MS or interruption due to side effects
  • Progressive aggravation in the disease's progression estimated by: deterioration in EDSS-plus disability scale, Timed 25-Foot Walk or 9-hole peg test.
  • Progressive aggravation in the disease's progression estimated by: new lesions in MRI scan and neuropsychological tests
  • Progressive aggravation in patient's neuropsychological status
  • Progressive aggravation in patient's Quality of life, estimated with MuSIQol - Greek 3.01 MS and SF-36
  • Years of education: >= 5
  • Proficient language fluency
  • Have a study partner with 10+ hr/wk contact (can be in person and telephone), accompanies to visits
  • Compliance

Exclusion Criteria:

  • Enrollment in other trials or studies not compatible with MSOIL
  • Visual and auditory acuity inadequate for neuropsychological testing
  • History of significant other neurological or psychiatric illnesses or presence of other diseases precluding enrollment.
  • Use of forbidden medications (listed below)
  • Ferromagnetic implants and devices (including implants or devices held in place by sutures, granulation or ingrowth of tissue, fixation devices, or by other means) not eligible for MRI scanning. Brain malformation or other conditions that may complicate lumbar puncture
  • Any significant or uncontrolled medical condition or treatment-emergent
  • Clinically significant laboratory abnormality

Medications across the study

Excluded Medication:

  • Immunosuppressant or immunomodulating agents, corticosteroids, or investigational drugs within 3 months of study initiation
  • Antibiotics in general, at least one month prior assessment of specific inflammatory markers (faecal levels of calprotectin, metabolomic profile, gut microbiota)
  • Use of neuroleptics or within 4 weeks of screening
  • Participation in any other investigational drug study within 4 weeks of screening (individuals may not participate in any drug study while participating in this protocol).

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group

Experimental Group 20 patients on Early Harvest Extra Virgin Olive Oil Aluminum bottle with 500 ml of early harvest extra virgin olive oil (3 tablespoons per day).

Dietary Supplement: Early Harvest Extra Virgin Olive Oil dietary intake of the content of 50 mL (3 tablespoons from the bottle containing the product)

Participants will take 3 tablespoons on a daily basis
Active Comparator: Control group
10 patients will not receive treatment with Extra Virgin Olive Oil
Participants will take 3 tablespoons on a daily basis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Greek Verbal Learning Test (GVLT)- Assessment of auditory and verbal memory
Time Frame: baseline, 6 and 12 months
Changes in Greek Verbal Learning Test (GVLT) score. Score range:0-80. Higher score indicates better outcome
baseline, 6 and 12 months
Brief Visuospatial Memory Test (BVMT)- Assessment of visual and spatial memory
Time Frame: baseline, 6 and 12 months
Changes in Brief Visuospatial Memory Test (BVMT) score. Score range:0-36. Higher score indicates better outcome
baseline, 6 and 12 months
Symbol Digit Modalities Test (SDMT)- Assessment of processing speed and working memory
Time Frame: baseline, 6 and 12 months
Changes in Symbol Digit Modalities Test (SDMT) score. Score range:1-110. Higher score indicates better outcome
baseline, 6 and 12 months
Perceived Deficits Questionnaire (PDQ)- Measurement of subjective cognitive deficits
Time Frame: baseline, 12 and 24 months
Changes in Perceived Deficits Questionnaire (PDQ) score. Score range:0-80. Lower score indicates better outcome
baseline, 12 and 24 months
Frontal Assessment Battery (FAB)- Assessment of frontal deficits
Time Frame: baseline, 6 and 12 months
Changes in Frontal Assessment Battery (FAB) score. Score Range:0-18. Higher score indictaes better outcome
baseline, 6 and 12 months
Beck Depression Scale (BDI)- Measurement of depressive symptoms
Time Frame: baseline, 6 and 12 months
Changes in Beck Depression Scale (BDI) score. Score range:0-63. Lower scores indicate better outcomes.
baseline, 6 and 12 months
Mental Health Inventory (MHI)- Measurement of emotional condition and mental health problems
Time Frame: baseline, 6 and 12 months
Changes in Mental Health Inventory (MHI) score. Score range:0-100. Higher score indicates better outcome
baseline, 6 and 12 months

Collaborators and Investigators

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

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)

November 9, 2018

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 6, 2021

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

October 8, 2019

First Posted (Actual)

October 9, 2019

Study Record Updates

Last Update Posted (Actual)

July 9, 2021

Last Update Submitted That Met QC Criteria

July 4, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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