Effects of Pomegranate Seed Oil and Mediterranean Diet at Motor Skills and Cognitive Abilities in Mild Cognitive Impairment.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Auditory Verbal Learning Test
研究概览
简要总结
A double-blind clinical trial of pomegranate oil and Mediterranean diet that will be carried out on 60 patients with Mild Cognitive Impairment (MCI) and APOE ε3 and ε4 allele.
The aim of the research is to examine if the Mediterranean diet with pomegranate oil and without it can bring positive changes in patients with MCI in terms of motor and cognitive skills.
详细描述
OBJECTIVES OF THE TRIAL
The objectives of this study are:
To investigate the efficacy of Mediterranean diet and Pomegranate oil as a disease course modifying treatment for MCI.
STUDY DESIGN This is a Greek, controlled double-blind trial of two compared groups, one with Mediterranean diet and one with Mediterranean diet and pomegranate oil. Qualifying patients will be assigned to receive 0.15 mL of pomegranate oil every day with Mediterranean diet at one group and at the other group will not. A Mediterranean dietary protocol will be given on a daily basis for 12 months at both groups.
Duration The total study duration will be 12 months. The recruitment will be about 6 months and the statistics and the preparation of the paper other 6 months.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Mild Cognitive Impairment
- •Carry APOE ε3 or ε4 genes
排除标准
- •Diagnosis of Dementia
- •Patients who receive medication for memory or depression
- •Patients who do not carry APOE ε3 or ε4 genes
研究组 & 干预措施
MD
Mediterranean Diet 30 patients Mediterranean dietary protocol Dietary Supplement: Mediterranean dietary protocol Intervention: Mediterranean diet
干预措施: Mediterranean Diet (Dietary Supplement)
MD + Seed oil
Pomegranate oil + Mediterranean Diet 30 patients Mediterranean dietary protocol Dietary Supplement: Pomegranate oil in a glass bottle of 30ml Dietary Supplement: Mediterranean dietary protocol
Intervention:
Mediterranean diet, Pomegranate oil
干预措施: Pomegranate oil, Mediterranean Diet (Dietary Supplement)
结局指标
主要结局
Auditory Verbal Learning Test
时间窗: baseline,12 months
Measurement to Assess Verbal Fluency and Learning Changes in the Auditory Verbal Learning Test
Boston Naming Test
时间窗: baseline,12 months
Measurement to Assess Verbal Fluency and Learning Changes in the Boston Naming Test
Fullerton Functional Test
时间窗: baseline,12 months
Measurement to Assess Physical Abilities
Mini-Mental State Examination (MMSE
时间窗: baseline,12 months
Score scale:0-30,cut off:24
FUCAS
时间窗: baseline,12 months
Measurements to Assess Daily Functionality Changes in Functional cognitive assessment scale (FUCAS) score Score scale:42-126,cut off:42
Letter & Category Fluency Test
时间窗: baseline,12 months
Measurement to Assess Verbal Fluency and Learning Changes in the Letter \& Category Fluency Test
CDR
时间窗: baseline,12 months
Measurements to Assess General Cognitive Function Changes in Global Clinical Dementia Rating (CDR)
MoCA
时间窗: baseline,12 months
Measurements to Assess General Cognitive Function Changes in Montreal Cognitive Assessment (MoCA)
CANTAB
时间窗: baseline,12 months
Measurements to Assess General Cognitive Function Changes in Cambridge Neuropsychological Test Automated Battery (CANTAB)
Clock Drawing test
时间窗: baseline,12 months
Measurements to Assess General Cognitive Function Changes in the Clock Drawing test
Logical Memory test
时间窗: baseline,12 months
Measurements to Assess General Cognitive Function Changes in the Logical Memory test
Digit Span Forward & Backward test
时间窗: baseline,12 months
Measurements to Assess General Cognitive Function Changes in the Digit Span Forward \& Backward test
WAIS-R Digit Symbol
时间窗: baseline,12 months
Measurements to Assess General Cognitive Function Changes in the WAIS-R Digit Symbol Substitution Test
TMT part A and B
时间窗: baseline,12 months
Measurements to Assess General Cognitive Function Changes in the Trail Making Test
ADASCog
时间窗: baseline,12 months
Measurements to Assess Daily Functionality Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog)
Functional Rating Scale for Dementia
时间窗: baseline,12 months
Measurements to Assess Daily Functionality Changes in Functional Rating Scale for Dementia (FRSSD)
次要结局
未报告次要终点
研究者
Magda Tsolaki
Professor of Neurology, Medical School, Aristotle University of Thessaloniki Affiliation: Aristotle University of Thessaloniki
Aristotle University Of Thessaloniki