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

NCT04120675 | Completed

• 1 other identifier: 43-Α/24-10-2018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Progressive Multiple Sclerosis

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Greek Verbal Learning Test (GVLT)- Assessment of auditory and verbal memory

  Changes in Greek Verbal Learning Test (GVLT) score. Score range:0-80. Higher score indicates better outcome

  baseline, 6 and 12 months

• Brief Visuospatial Memory Test (BVMT)- Assessment of visual and spatial memory

  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

  Changes in Symbol Digit Modalities Test (SDMT) score. Score range:1-110. Higher score indicates better outcome

  baseline, 6 and 12 months

• Perceived Deficits Questionnaire (PDQ)- Measurement of subjective cognitive deficits

  Changes in Perceived Deficits Questionnaire (PDQ) score. Score range:0-80. Lower score indicates better outcome

  baseline, 12 and 24 months

• Frontal Assessment Battery (FAB)- Assessment of frontal deficits

  Changes in Frontal Assessment Battery (FAB) score. Score Range:0-18. Higher score indictaes better outcome

  baseline, 6 and 12 months

• Beck Depression Scale (BDI)- Measurement of depressive symptoms

  Changes in Beck Depression Scale (BDI) score. Score range:0-63. Lower scores indicate better outcomes.

  baseline, 6 and 12 months

• Mental Health Inventory (MHI)- Measurement of emotional condition and mental health problems

  Changes in Mental Health Inventory (MHI) score. Score range:0-100. Higher score indicates better outcome

  baseline, 6 and 12 months

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

10 patients will not receive treatment with Extra Virgin Olive Oil

Dietary Supplement: Early Harvest Extra Virgin Olive Oil

Interventions

Early Harvest Extra Virgin Olive Oil DIETARY_SUPPLEMENT

Participants will take 3 tablespoons on a daily basis

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• Greek Alzheimer's Association and Related Disorders: collaborator
• Ellis-Farm, Eliama Daily Value Gold (ellis-farm.com): collaborator

Study Sites (1)

A' Department of Neurology,Aristotle University of Thessaloniki (AUTH)

Thessaloniki, Macedonia, 546 36, Greece

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Psychological Well-Being; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: October 9, 2019
• Study Start: November 9, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 6, 2021
• Last Updated: July 9, 2021

Record last verified: 2021-07

Locations

GR (1)