Efficacy of Early Harvest Olive Oil in Cognition of Primary (PPMS) or Secondary (SPMS) Progressive Multiple Sclerosis
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ClinicalTrials.gov Identifier: NCT04120675 |
Recruitment Status :
Completed
First Posted : October 9, 2019
Last Update Posted : July 9, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Progressive Multiple Sclerosis | Dietary Supplement: Early Harvest Extra Virgin Olive Oil | Not Applicable |
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 (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | November 9, 2018 |
Actual Primary Completion Date : | June 1, 2021 |
Actual Study Completion Date : | June 6, 2021 |

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) |
Dietary Supplement: Early Harvest Extra Virgin Olive Oil
Participants will take 3 tablespoons on a daily basis |
Active Comparator: Control group
10 patients will not receive treatment with Extra Virgin Olive Oil
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Dietary Supplement: Early Harvest Extra Virgin Olive Oil
Participants will take 3 tablespoons on a daily basis |
- 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
- 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
- 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
- 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
- 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
- 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.
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04120675
Greece | |
A' Department of Neurology,Aristotle University of Thessaloniki (AUTH) | |
Thessaloniki, Macedonia, Greece, 546 36 |
Responsible Party: | Magda Tsolaki, MD, PhD, Professor, Aristotle University Of Thessaloniki |
ClinicalTrials.gov Identifier: | NCT04120675 |
Other Study ID Numbers: |
43-Α/24-10-2018 |
First Posted: | October 9, 2019 Key Record Dates |
Last Update Posted: | July 9, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
extra virgin olive oil cognition mental health multiple sclerosis |
Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS |
Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |