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

• ClinicalTrials.gov Identifier: NCT04120675
• Recruitment Status: Completed
• First Posted: October 9, 2019
• Last Update Posted: July 9, 2021
• Sponsor: Aristotle University Of Thessaloniki
• 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

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

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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).

Contacts and Locations

Locations

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)

More Information

• 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
• 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

Keywords provided by Magda Tsolaki, Aristotle University Of Thessaloniki:

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

Additional relevant MeSH terms:

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