Pilot Study About Extra Virgin Oil "Coratina" (Evoo-c) in Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD) Patients (EVOO-c in MCI/AD)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 主要终点
- Evaluate the change of neurodegenerative biomarkers after olive oil supplementation.
研究概览
简要总结
Alzheimer's Disease is a neurodegenerative disease age related caused by neurofibrillary tangles misfolding and Beta-amyloid protein accumulation. In the last decade several findings showed the role of biophenols present in diary intake such as extra virgin olive oil as potential antagonist of neurodegeneration. Two population studies (The Seven Countries Study and Three-City-Study) and four clinical trials (PREDIMED, PREDIMED - NAVARRA, ACTRIN and ISRCTN) have already suggested that mediterranean diet or other diets supplemented with extra virgin olive oil could improve cerebral performance.
详细描述
24 MCI or Alzheimer's Disease patients will be recruited and randomised; 12 of them will receive extra virgin olive oil "coratina" (EVOO-C); 12 of them will receive biophenol low dose olive oil (ROO). Each patient will consume a total amount of 10 mg olive oil in a year (12 months). Clinical assessement will be based on:
- neurological examination (T0, T6, T12);
- cardiological examination (T0, T12): a supra-aortic vessels and brachial artery ecocolordoppler will be performed;
- ophthalmological evaluation (T0, T12): a optic coherence tomography will be performed;
- neuropsychological assessment (T0, T12);
- nutritional assessement(T0, T3, T6, T9, T12).
Each subject will perform:
- brain MRI (T0, T12);
- Beta Amyloid Positron Emission Tomography (T0, T12) A lumbar puncture will be ruled as well (T0) and markers of neurodegeneration (Beta-amyloid 1 - 42, total tau protein, fosfo-tau, Brain Derived Neurotrophic Factor (BDNF), Neurofilament (NFL) will be quantified); Renal, hepatic and nutritional status will be assessed 3 times in 12 months (T0, T6, T12).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MCI diagnosis in the last month prior the recruitment;
- •Clinical Dementia Rating Scale - Global Score (CDR - GS) 0,5 and Mini Mental Examination 24 - 27;
排除标准
- •hypertension;
- •diabetes;
- •positive history of stroke, epilepsy or cardiac disease;
- •BMI > 30;
- •depression or other psychiatric disturbances;
- •low compliance to medical interventions;
- •positive history of olive oil allergy or intolerance;
- •positive history of chronic inflammatory intestinal disease or malabsorption;
- •positive history of maculopathy or retinopathy;
- •MRI leukoaraiosis II-III grade Fazekas or MRI lacunar infarctions
结局指标
主要结局
Evaluate the change of neurodegenerative biomarkers after olive oil supplementation.
时间窗: Change from baseline neurodegenerative biomarkers at 12 months
Neurodegenerative biomarkers will be tested with blood samples and with cerebrospinal fluid analysis (cerebrospinal level of Beta-amyloid, Tau and phosphotau, BDNF (pg/mL; blood level of BDNF e NFL (pg/mL))
Evaluate the change of optic nerve and macula thickness after olive oil supplementation.
时间窗: Change from baseline optic nerve and macula thickness at 12 months
Ocular computerized tomography will be performed and layer of retinal nerve fiber will be measured (micron)
Evaluate the change of nutritional parameters after olive oil supplementation
时间窗: Change from baseline BMI at 3 months, from baseline BMI at 6 months, from baseline BMI at 12 months
Weight and height will be combined to report BMI in Kg/m\^2. Nutritional assessment will be measured comparing the variation of BMI of each patient during the follow up.
Evaluate the change of cerebral performance after olive oil supplementation.
时间窗: Change from baseline MMSE score at 12 months
The change of cerebral performance will be documented by neuropsychological assessement with Minimental State Examination (MMSE) (total score)
Evaluate the change of cortical thickness with brain MRI after olive oil supplementation.
时间窗: Change from baseline at 12 months
Brain MRI will be performed to assess cortical thickness using Normalized Thickness Index (NTI)
Evaluate the change of brain amyloid plaque load (BAPL) after olive oil supplementation.
时间窗: Change from baseline BAPL at 12 months
Beta amyloid positron emission tomography will be performed measuring a index called BAPL.
次要结局
未报告次要终点
研究者
Maria Trojano
Full Professor
University of Bari Aldo Moro