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

Primary Purpose

Progressive Multiple Sclerosis

Status

Completed

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

Early Harvest Extra Virgin Olive Oil

About this trial

This is an interventional treatment trial for Progressive Multiple Sclerosis focused on measuring extra virgin olive oil, cognition, mental health, multiple sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

A' Department of Neurology,Aristotle University of Thessaloniki (AUTH)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

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)

10 patients will not receive treatment with Extra Virgin Olive Oil

Outcomes

Primary Outcome Measures

Greek Verbal Learning Test (GVLT)- Assessment of auditory and verbal memory

Changes in Greek Verbal Learning Test (GVLT) score. Score range:0-80. Higher score indicates better outcome

Brief Visuospatial Memory Test (BVMT)- Assessment of visual and spatial memory

Changes in Brief Visuospatial Memory Test (BVMT) score. Score range:0-36. Higher score indicates better outcome

Symbol Digit Modalities Test (SDMT)- Assessment of processing speed and working memory

Changes in Symbol Digit Modalities Test (SDMT) score. Score range:1-110. Higher score indicates better outcome

Perceived Deficits Questionnaire (PDQ)- Measurement of subjective cognitive deficits

Changes in Perceived Deficits Questionnaire (PDQ) score. Score range:0-80. Lower score indicates better outcome

Frontal Assessment Battery (FAB)- Assessment of frontal deficits

Changes in Frontal Assessment Battery (FAB) score. Score Range:0-18. Higher score indictaes better outcome

Beck Depression Scale (BDI)- Measurement of depressive symptoms

Changes in Beck Depression Scale (BDI) score. Score range:0-63. Lower scores indicate better outcomes.

Mental Health Inventory (MHI)- Measurement of emotional condition and mental health problems

Changes in Mental Health Inventory (MHI) score. Score range:0-100. Higher score indicates better outcome

Secondary Outcome Measures

Full Information

NCT ID

NCT04120675

First Posted

September 24, 2019

Last Updated

July 4, 2021

Sponsor

Aristotle University Of Thessaloniki

Collaborators

Greek Alzheimer's Association and Related Disorders, Ellis-Farm, Eliama Daily Value Gold (ellis-farm.com)

1. Study Identification

Unique Protocol Identification Number

NCT04120675

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

November 9, 2018 (Actual)

Primary Completion Date

June 1, 2021 (Actual)

Study Completion Date

June 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aristotle University Of Thessaloniki

Collaborators

Greek Alzheimer's Association and Related Disorders, Ellis-Farm, Eliama Daily Value Gold (ellis-farm.com)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Progressive Multiple Sclerosis

Keywords

extra virgin olive oil, cognition, mental health, multiple sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

10 patients will not receive treatment with Extra Virgin Olive Oil

Intervention Type

Dietary Supplement

Intervention Name(s)

Early Harvest Extra Virgin Olive Oil

Intervention Description

Participants will take 3 tablespoons on a daily basis

Primary Outcome Measure Information:

Title

Greek Verbal Learning Test (GVLT)- Assessment of auditory and verbal memory

Description

Changes in Greek Verbal Learning Test (GVLT) score. Score range:0-80. Higher score indicates better outcome

Time Frame

baseline, 6 and 12 months

Title

Brief Visuospatial Memory Test (BVMT)- Assessment of visual and spatial memory

Description

Changes in Brief Visuospatial Memory Test (BVMT) score. Score range:0-36. Higher score indicates better outcome

Time Frame

baseline, 6 and 12 months

Title

Symbol Digit Modalities Test (SDMT)- Assessment of processing speed and working memory

Description

Changes in Symbol Digit Modalities Test (SDMT) score. Score range:1-110. Higher score indicates better outcome

Time Frame

baseline, 6 and 12 months

Title

Perceived Deficits Questionnaire (PDQ)- Measurement of subjective cognitive deficits

Description

Changes in Perceived Deficits Questionnaire (PDQ) score. Score range:0-80. Lower score indicates better outcome

Time Frame

baseline, 12 and 24 months

Title

Frontal Assessment Battery (FAB)- Assessment of frontal deficits

Description

Changes in Frontal Assessment Battery (FAB) score. Score Range:0-18. Higher score indictaes better outcome

Time Frame

baseline, 6 and 12 months

Title

Beck Depression Scale (BDI)- Measurement of depressive symptoms

Description

Changes in Beck Depression Scale (BDI) score. Score range:0-63. Lower scores indicate better outcomes.

Time Frame

baseline, 6 and 12 months

Title

Mental Health Inventory (MHI)- Measurement of emotional condition and mental health problems

Description

Changes in Mental Health Inventory (MHI) score. Score range:0-100. Higher score indicates better outcome

Time Frame

baseline, 6 and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Facility Information:

Facility Name

A' Department of Neurology,Aristotle University of Thessaloniki (AUTH)

City

Thessaloniki

State/Province

Macedonia

ZIP/Postal Code

546 36

Country

Greece

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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