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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04120675
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
Sponsor:
Collaborators:
Greek Alzheimer's Association and Related Disorders
Yanni's Olive Grove
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, Double Blind, Controlled Prospective Study, is to evaluate the effect of freshly-pressed extra virgin olive oil in the progression of the cognition in patients diagnosed with PPMS or SPMS. Specific inflammatory markers in blood, stool and CSF will be detected to confirm the general, beneficial effect of freshly pressed EVOO on the gut microbiota, the metabolomic profile and the immune system of patients, as their cross-interaction has been shown in many clinical studies. Positive results of this mild,nutritional, therapeutic intervention can also lead to the clinical use of these biomarkers for both diagnosis and follow up of the patients.

Condition or disease Intervention/treatment Phase
Progressive Multiple Sclerosis Dietary Supplement: Freshly-Pressed Extra Virgin Olive Oil Not Applicable

Detailed Description:

Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention OBJECTIVES OF THE TRIAL The objectives of this study are:To investigate the efficacy of freshly pressed EVOO as a disease course modifying treatment for primary (PPMS) or secondary (SPMS) progressive multiple sclerosis in a phase III double-blind -controlled study in objective measurements in patients with primary (PPMS) or secondary (SPMS) progressive multiple sclerosis.

STUDY DESIGN This is a Greek, randomized, double-blind, -controlled study group of Freshly-Pressed EVOO + MeDi compared to EVOO + MeDi and to Medi only. Qualifying patients will be randomly assigned to receive 50mL of freshly-pressed EVOO or extra virgin olive oil or MeDi dietary protocol on a daily basis for 24 months. Patients undergo assessments at baseline,12 and 24 months +/- 7 days after beginning treatment.

Duration: The total study duration will be 30 months. Patients will receive study interventions for 24 months.

Number of Subjects 150 subjects total will be enrolled; 50 in the experimental group (freshly pressed EVOO+MeDi); 50 in the Control Group 1(extra virgin olive oil+MeDi) and 50 in control Group 2(same dietary habits-MeDi protocol).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double (Participant and neuropsychologist)
Primary Purpose: Prevention
Official Title: Randomized, Double Blind, Controlled Prospective Study, to Evaluate the Therapeutic Effects of Early Harvest Olive Oil in Cognitive Functions of Patients With Primary (PPMS) or Secondary (SPMS) Progressive Multiple Sclerosis.
Actual Study Start Date : November 9, 2018
Estimated Primary Completion Date : February 15, 2020
Estimated Study Completion Date : May 15, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Olive oil

Arm Intervention/treatment
Experimental: 3 Arms and Interventions

Experimental Group 50 patients on Freshly-Pressed Extra Virgin Olive Oil Aluminum bottle with 500 ml of freshly-pressed extra virgin olive oil 1 bottle per 10 days.

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

Dietary Supplement: Freshly-Pressed Extra Virgin Olive Oil
This is a Greek, randomized, double-blind, -controlled study group of Freshly-Pressed EVOO + MeDi compared to EVOO + MeDi and to Medi only. Qualifying patients will be randomly assigned to receive 50mL of freshly-pressed EVOO or extra virgin olive oil or MeDi dietary protocol on a daily basis for 24 months. Patients undergo assessments at baseline,12 and 24 months +/- 7 days after beginning treatment.

Active Comparator: Control group 1
50 patients on Extra Virgin Olive Oil Aluminum bottle with 500 ml of freshly-pressed extra virgin olive oil 1 bottle per 10 days. Extra Virgin Olive Oil dietary intake of the content of 50 mL (3 tablespoons from the bottle containing the product)
Dietary Supplement: Freshly-Pressed Extra Virgin Olive Oil
This is a Greek, randomized, double-blind, -controlled study group of Freshly-Pressed EVOO + MeDi compared to EVOO + MeDi and to Medi only. Qualifying patients will be randomly assigned to receive 50mL of freshly-pressed EVOO or extra virgin olive oil or MeDi dietary protocol on a daily basis for 24 months. Patients undergo assessments at baseline,12 and 24 months +/- 7 days after beginning treatment.

No Intervention: Control Group 2
50 patients will have the same dietary habits and a MeDi protocol



Primary Outcome Measures :
  1. Neuropsychological Assessment - Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in Mini-Mental State Examination (MMSE) score

  2. FUCAS-Measurements to Assess Daily Functionality [ Time Frame: baseline, 12 and 24 months ]
    Changes in Functional cognitive assessment scale (FUCAS) score

  3. Letter & Category Fluency Test- Measurement to Assess Verbal Fluency and Learning [ Time Frame: baseline, 12 and 24 months ]
    Changes in the Letter & Category Fluency Test

  4. CDR- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in Global Clinical Dementia Rating (CDR) score (sum of boxes

  5. MoCA- Measurements to Assess General Cognitive Function [ Time Frame: Time Frame: baseline, 12 and 24 months ]
    Changes in Montreal Cognitive Assessment (MoCA)

  6. CANTAB- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in Cambridge Neuropsychological Test Automated Battery (CANTAB)

  7. Clock Drawing test- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in the Clock Drawing test

  8. Logical Memory test- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in the Logical Memory test

  9. Digit Span Forward & Backward test- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in the Digit Span Forward & Backward test

  10. WAIS-R Digit Symbol- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in the WAIS-R Digit Symbol Substitution Test

  11. TMT part A and B- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in the Trail Making Test

  12. ADASCog-Measurements to Assess Daily Functionality [ Time Frame: baseline, 12 and 24 months ]
    Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog)

  13. Functional Rating Scale for Dementia-Measurements to Assess Daily Functionality [ Time Frame: baseline, 12 and 24 months ]
    Changes in Functional Rating Scale for Dementia (FRSSD)

  14. Auditory Verbal Learning Test- Measurement to Assess Verbal Fluency and Learning [ Time Frame: baseline, 12 and 24 months ]
    Changes in the Auditory Verbal Learning Test

  15. Boston Naming Test- Measurement to Assess Verbal Fluency and Learning [ Time Frame: baseline, 12 and 24 months ]
    Changes in the Boston Naming Test


Secondary Outcome Measures :
  1. NeuroImaging [ Time Frame: baseline, 12 and 24 months ]
    Changes in brain Magnetic Resonance Imaging (MRI) 1.5 Tesla (brain atrophy)

  2. CSF - beta amyloid [ Time Frame: baseline, 12 and 24 months ]
    Changes in mean values on high sensitivity beta-amyloid 1-42 protein

  3. CSF TAU-protein [ Time Frame: baseline, 12 and 24 months ]
    Changes in mean values on TAU-protein in cerebrospinal fluid

  4. Neurophysiology and ERPs [ Time Frame: Time Frame: baseline, 12 and 24 months ]
    •Changes in Event-Related Potential (ERP) (oddball paradigm, auditory ERPs)

  5. Electroencephalography recording [ Time Frame: Time Frame: baseline, 12 and 24 months ]
    •Changes in Electroencephalography (EEG), resting state.The device records brain signals through 57 electrodes, 2 reference electrodes attached to the earlobes, and a ground electrode placed at a left anterior position


Other Outcome Measures:
  1. Weight in Kilograms [ Time Frame: baseline, 12 and 24 months ]
    Changes in weight

  2. Height in Meters [ Time Frame: baseline, 12 and 24 months ]
    Changes in Height



Information from the National Library of Medicine

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.


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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


Contacts
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Contact: Magda Tsolaki, MD,PhD,Professor 0030 2310 2411 56 tsolakim1@gmail.com
Contact: THOMAS CHATZINTOUNAS, MD,PhD tomchatzidounas@gmail.com

Locations
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Greece
A' Department of Neurology,Aristotle University of Thessaloniki (AUTH) Recruiting
Thessaloniki, Macedonia, Greece, 546 36
Contact: Magda Tsolaki, MD, PhD, Professor    0030 2310 2411 56    tsolakim1@gmail.com   
Principal Investigator: Magda Tsolaki, MD, PhD, Professor         
Sub-Investigator: Thomas Chatzintounas, MD, PhD,Neurologist         
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Greek Alzheimer's Association and Related Disorders
Yanni's Olive Grove
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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: October 9, 2019
Last Verified: October 2019
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
primary (PPMS) progressive multiple sclerosis
secondary (SPMS) progressive multiple sclerosis
randomized double blind clinical trial
cognition
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