Efficacy of Early Harvest Olive Oil in Cognition of Primary (PPMS) or
The Effects of Early Harvest Extra Virgin Olive Oil on Cognition and Mental Health of Primary (PPMS) or Secondary (SPMS) Progressive Multiple Sclerosis Patients
What it found
We found no results in the registry or in papers.
This trial finished 5 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Early Harvest Extra Virgin Olive Oil
What it measured
Main measures
Greek Verbal Learning Test (GVLT)- Assessment of auditory and verbal memory
baseline, 6 and 12 months
Thinking and memoryBrief Visuospatial Memory Test (BVMT)- Assessment of visual and spatial memory
baseline, 6 and 12 months
Thinking and memorySymbol Digit Modalities Test (SDMT)- Assessment of processing speed and working memory
baseline, 6 and 12 months
Thinking and memoryPerceived Deficits Questionnaire (PDQ)- Measurement of subjective cognitive deficits
baseline, 12 and 24 months
Thinking and memoryFrontal Assessment Battery (FAB)- Assessment of frontal deficits
baseline, 6 and 12 months
Beck Depression Scale (BDI)- Measurement of depressive symptoms
baseline, 6 and 12 months
Mood and sleepMental Health Inventory (MHI)- Measurement of emotional condition and mental health problems
baseline, 6 and 12 months
Who could take part
Progressive MS · 18 to 65
Show the full 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).
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
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History
Started
Nov 2018
Main results due
Jun 2021
Finished
Jun 2021