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| Name | Class |
|---|---|
| Greek Alzheimer's Association and Related Disorders | OTHER |
| Ellis-Farm, Eliama Daily Value Gold (ellis-farm.com) | UNKNOWN |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| Control group | Active Comparator | 10 patients will not receive treatment with Extra Virgin Olive Oil |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Harvest Extra Virgin Olive Oil | Dietary Supplement | Participants will take 3 tablespoons on a daily basis |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Medications across the study
Excluded Medication:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A' Department of Neurology,Aristotle University of Thessaloniki (AUTH) | Thessaloniki | Macedonia | 546 36 | Greece |
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| ID | Term |
|---|---|
| D020528 | Multiple Sclerosis, Chronic Progressive |
| D000092862 | Psychological Well-Being |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Parallel Assignment
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Changes in Mental Health Inventory (MHI) score. Score range:0-100. Higher score indicates better outcome |
| baseline, 6 and 12 months |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |