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Progressive Multiple SclerosisNCT04120675

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

A study testing Early Harvest Extra Virgin Olive Oil in people with Progressive Multiple Sclerosis, run by Aristotle University Of Thessaloniki at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Progressive Multiple Sclerosis
What is being tested?
Early Harvest Extra Virgin Olive Oil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteGreece
Study dates
9 Nov 2018to 6 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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).

Trial locations and contacts

1 site in 1 country.

Greece1 site

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

    Thessaloniki, Macedonia, 546 36

Other trials in Greece

About this study

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

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

Read the 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

Being tested
Early Harvest Extra Virgin Olive Oil
Keywords
extra virgin olive oil, cognition, mental health, multiple sclerosis
Medical subject headings
Multiple Sclerosis, Chronic Progressive, Psychological Well-Being, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early Harvest Extra Virgin Olive OilDietary supplement

    Participants will take 3 tablespoons on a daily basis

Study groups in NCT04120675
Study groupRoleWhat they receive
Experimental groupExperimentalExperimental 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)
Receives: Dietary Supplement: Early Harvest Extra Virgin Olive Oil
Control groupActive comparator10 patients will not receive treatment with Extra Virgin Olive Oil
Receives: Dietary Supplement: Early Harvest Extra Virgin Olive Oil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: baseline, 6 and 12 months

  2. 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

    Measured: baseline, 6 and 12 months

  3. 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

    Measured: baseline, 6 and 12 months

  4. 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

    Measured: baseline, 12 and 24 months

  5. Frontal Assessment Battery (FAB)- Assessment of frontal deficits

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

    Measured: baseline, 6 and 12 months

  6. Beck Depression Scale (BDI)- Measurement of depressive symptoms

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

    Measured: baseline, 6 and 12 months

  7. 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

    Measured: baseline, 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2019
  2. Study start9 Nov 2018
  3. Primary completion1 Jun 2021
  4. Study completion6 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Single blind
Who is masked
Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04120675
Sponsor's protocol ID
43-Α/24-10-2018
Status last verified
Jul 2021
First submitted
24 Sep 2019
Last updated
9 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Early Harvest Extra Virgin Olive Oil in people with Progressive Multiple Sclerosis, run by Aristotle University Of Thessaloniki at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Greek Verbal Learning Test (GVLT)- Assessment of auditory and verbal memory (time frame: baseline, 6 and 12 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04120675.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021.

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