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

2019-10-15 11:11:06 | BioPortfolio

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, Double Blind, Controlled Prospective Study, is to evaluate the effect of freshly-pressed extra virgin olive oil in the progression of the cognition in patients diagnosed with PPMS or SPMS. Specific inflammatory markers in blood, stool and CSF will be detected to confirm the general, beneficial effect of freshly pressed EVOO on the gut microbiota, the metabolomic profile and the immune system of patients, as their cross-interaction has been shown in many clinical studies. Positive results of this mild,nutritional, therapeutic intervention can also lead to the clinical use of these biomarkers for both diagnosis and follow up of the patients.

Description

Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention OBJECTIVES OF THE TRIAL The objectives of this study are:To investigate the efficacy of freshly pressed EVOO as a disease course modifying treatment for primary (PPMS) or secondary (SPMS) progressive multiple sclerosis in a phase III double-blind -controlled study in objective measurements in patients with primary (PPMS) or secondary (SPMS) progressive multiple sclerosis.

STUDY DESIGN This is a Greek, randomized, double-blind, -controlled study group of Freshly-Pressed EVOO + MeDi compared to EVOO + MeDi and to Medi only. Qualifying patients will be randomly assigned to receive 50mL of freshly-pressed EVOO or extra virgin olive oil or MeDi dietary protocol on a daily basis for 24 months. Patients undergo assessments at baseline,12 and 24 months +/- 7 days after beginning treatment.

Duration: The total study duration will be 30 months. Patients will receive study interventions for 24 months.

Number of Subjects 150 subjects total will be enrolled; 50 in the experimental group (freshly pressed EVOO+MeDi); 50 in the Control Group 1(extra virgin olive oil+MeDi) and 50 in control Group 2(same dietary habits-MeDi protocol).

Study Design

Conditions

Progressive Multiple Sclerosis

Intervention

Freshly-Pressed Extra Virgin Olive Oil

Location

A' Department of Neurology,Aristotle University of Thessaloniki (AUTH)
Thessaloniki
Macedonia
Greece
546 36

Status

Recruiting

Source

Aristotle University Of Thessaloniki

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-15T11:11:06-0400

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Medical and Biotech [MESH] Definitions

A form of multiple sclerosis characterized by a progressive deterioration in neurologic function which is in contrast to the more typical relapsing remitting form. If the clinical course is free of distinct remissions, it is referred to as primary progressive multiple sclerosis. When the progressive decline is punctuated by acute exacerbations, it is referred to as progressive relapsing multiple sclerosis. The term secondary progressive multiple sclerosis is used when relapsing remitting multiple sclerosis evolves into the chronic progressive form. (From Ann Neurol 1994;36 Suppl:S73-S79; Adams et al., Principles of Neurology, 6th ed, pp903-914)

An autoimmune disorder mainly affecting young adults and characterized by destruction of myelin in the central nervous system. Pathologic findings include multiple sharply demarcated areas of demyelination throughout the white matter of the central nervous system. Clinical manifestations include visual loss, extra-ocular movement disorders, paresthesias, loss of sensation, weakness, dysarthria, spasticity, ataxia, and bladder dysfunction. The usual pattern is one of recurrent attacks followed by partial recovery (see MULTIPLE SCLEROSIS, RELAPSING-REMITTING), but acute fulminating and chronic progressive forms (see MULTIPLE SCLEROSIS, CHRONIC PROGRESSIVE) also occur. (Adams et al., Principles of Neurology, 6th ed, p903)

A non-glycosylated form of interferon beta-1 that has a serine at position 17. It is used in the treatment of both RELAPSING-REMITTING MULTIPLE SCLEROSIS and CHRONIC PROGRESSIVE MULTIPLE SCLEROSIS.

Oil extracted from fruit of the OLIVE TREE (genus Olea).

A plant genus of the family OLEACEAE. The olive fruit is the source of olive oil.

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