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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04120675
Recruitment Status : Completed
First Posted : October 9, 2019
Last Update Posted : July 9, 2021
Sponsor:
Collaborators:
Greek Alzheimer's Association and Related Disorders
Ellis-Farm, Eliama Daily Value Gold (ellis-farm.com)
Information provided by (Responsible Party):
Magda Tsolaki, Aristotle University Of Thessaloniki

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

Condition or disease Intervention/treatment Phase
Progressive Multiple Sclerosis Dietary Supplement: Early Harvest Extra Virgin Olive Oil Not Applicable

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

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Olive oil

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
Dietary Supplement: Early Harvest Extra Virgin Olive Oil
Participants will take 3 tablespoons on a daily basis




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

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


Locations
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Greece
A' Department of Neurology,Aristotle University of Thessaloniki (AUTH)
Thessaloniki, Macedonia, Greece, 546 36
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Greek Alzheimer's Association and Related Disorders
Ellis-Farm, Eliama Daily Value Gold (ellis-farm.com)
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Magda Tsolaki, Aristotle University Of Thessaloniki:
extra virgin olive oil
cognition
mental health
multiple sclerosis
Additional relevant MeSH terms:
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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