- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04120675
Efficacy of Early Harvest Olive Oil in Cognition of Primary (PPMS) or Secondary (SPMS) Progressive Multiple Sclerosis
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Macedonia
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Thessaloniki, Macedonia, Greece, 546 36
- A' Department of Neurology,Aristotle University of Thessaloniki (AUTH)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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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
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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
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Perceived Deficits Questionnaire (PDQ)- Measurement of subjective cognitive deficits
Time Frame: baseline, 12 and 24 months
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Changes in Perceived Deficits Questionnaire (PDQ) score.
Score range:0-80.
Lower score indicates better outcome
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baseline, 12 and 24 months
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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
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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.
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baseline, 6 and 12 months
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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
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baseline, 6 and 12 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 43-Α/24-10-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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