The Effects of Early Harvest Extra Virgin Olive Oil on Cognition and Mental Health of Primary (PPMS) or Secondary (SPMS) Progressive Multiple Sclerosis Patients

Aristotle University Of Thessaloniki2 个研究点分布在 1 个国家目标入组 30 人开始时间: 2018年11月9日最近更新: 2021年7月9日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Aristotle University Of Thessaloniki
入组人数: 30
试验地点: 2
主要终点: Frontal Assessment Battery (FAB)- Assessment of frontal deficits

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

详细描述

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

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Single (Investigator)

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Confirmed diagnosis of primary (PPMS) or secondary (SPMS) progressive multiple sclerosis
•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

排除标准

•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).