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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 July 2021
• Main ID: NCT04120675
• Date of registration: 24/09/2019
• Prospective Registration: No
• Primary sponsor: Aristotle University Of Thessaloniki
• Public title: Efficacy of Early Harvest Olive Oil in Cognition of Primary (PPMS) or Secondary (SPMS) Progressive Multiple Sclerosis
• Scientific 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
• Date of first enrolment: November 9, 2018
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04120675
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
• Phase: N/A

Countries of recruitment

Greece

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Progressive Multiple Sclerosis

Intervention(s)

Dietary Supplement: Early Harvest Extra Virgin Olive Oil

Primary Outcome(s)

Frontal Assessment Battery (FAB)- Assessment of frontal deficits [Time Frame: baseline, 6 and 12 months]

Brief Visuospatial Memory Test (BVMT)- Assessment of visual and spatial memory [Time Frame: baseline, 6 and 12 months]

Greek Verbal Learning Test (GVLT)- Assessment of auditory and verbal memory [Time Frame: baseline, 6 and 12 months]

Perceived Deficits Questionnaire (PDQ)- Measurement of subjective cognitive deficits [Time Frame: baseline, 12 and 24 months]

Symbol Digit Modalities Test (SDMT)- Assessment of processing speed and working memory [Time Frame: baseline, 6 and 12 months]

Beck Depression Scale (BDI)- Measurement of depressive symptoms [Time Frame: baseline, 6 and 12 months]

Mental Health Inventory (MHI)- Measurement of emotional condition and mental health problems [Time Frame: baseline, 6 and 12 months]

Secondary ID(s)

43-?/24-10-2018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ellis-Farm, Eliama Daily Value Gold (ellis-farm.com)

Greek Alzheimer's Association and Related Disorders