Hydroxytyrosol-Rich Olive Juice Polyphenol and Mediterranean Diet (The MEDIPHENO-HTrial) in Prevention of Cognitive Decline in Community-Dwelling Patients With Mild Cognitive Impairment: A Double-Blind, Placebo-Controlled, 3-Arm, Randomised Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Primary: Mean change on the Alzheimer's Disease (AD) Assessment Scale-Cognitive Subscale (ADAS-Cog) total score from baseline to Week 52 compared with placebo
研究概览
简要总结
Nutrition is an important modifiable risk factor of human cognitive health. Increasing data suggests that certain nutrients or food ingredients, such as plant polyphenols, have the potential to benefit cognitive abilities even in later life. In terms of polyphenols, Hydroxytyrosol (HT) has gained health benefit claims as a potential preventative antioxidant supplementation of neurodegenerative and amyloid-associated diseases while its pharmacological mechanisms suggest protection against cognitive decline. The primary objective of this study will be to evaluate the effects of HT-rich olive juice polyphenol supplementation alongside MeDi adherence compared with placebo alongside MeDi adherence in the prevention of cognitive decline among patients with Mild Cognitive Impairment associated with AD and non-AD pathology.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GR-based men and women aged 50 - 85
- •Willingness and ability to conform to the full protocol.
- •Ability to accept and sign the consent form.
- •Presence of a diagnostic classification of Mild Cognitive Impairment according to the National Institute on Aging and Alzheimer's Association (NIA-AA) framework MCI, which corresponds to stage 3 on the pre-dementia range.
- •MoCA score of ≥18 and ≤
- •MMSE (Mini-Mental State Examination) score of ≥26 and ≤
- •No active suicide ideation based on the Columbia-Suicide Severity Rating Scale.
- •Absence of severe depressive symptomatology based on the Geriatric Depression Scale-
- •Not using any laxative drugs for at least three days prior to the screening visit.
- •Information about APOE status
排除标准
- •Patients with mild, moderate, or severe dementia.
- •Current or recent (within the last 4 weeks) engagement with a strict dietary regime i.e., vegetarian / vegan / ketogenic / paleolithic / high protein / weight loss.
- •Any known issues with blood taking.
- •Any known bleeding disorders.
- •Any known allergy to olives, inability to tolerate gluten or multiple allergies/intolerances that would significantly limit food intake.
- •Average alcohol use of >21 glasses per week for men and >14 glasses per week for women (on average for the last six months).
- •History of psychiatric illness including intellectual disability, schizophrenia, bipolar disorder, severe, active depression and alcoholism.
- •Neurologic conditions such as vascular dementia, movement disorders, history of conditions such as anaemia and cancer in the last five years, renal or liver failure, malignant tumours, or organ transplant.
- •Coffee consumption greater than 5 cups per day.
- •Body mass index > 35 kg/ m
- •Not taking a stable dose of statins for at least 3 months before the recruitment visit. Taking antibiotics in the 1 week preceding the recruitment visit.
- •Pregnancy or lactation.
- •Participation in another clinical trial during the last 30 days prior to the recruitment visit.
- •Subject taking supplements that may affect lipoprotein metabolism, >1 g of fish oil/day, antioxidant supplements, cannabidiol (CBD) oil.
研究组 & 干预措施
Experimental Arm - High Dose
High dose: 16 drops (40mg of polyphenols) + Mediterranean Diet instructions
干预措施: High-Dose Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement (Dietary Supplement)
Placebo Comparator Arm
Placebo 8 drops + Mediterranean Diet instructions
干预措施: Placebo (Dietary Supplement)
Active Arm - Low Dose
Low dose: 8 drops (20mg of polyphenols) + Mediterranean Diet instructions
干预措施: Low-Dose Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement (Dietary Supplement)
结局指标
主要结局
Primary: Mean change on the Alzheimer's Disease (AD) Assessment Scale-Cognitive Subscale (ADAS-Cog) total score from baseline to Week 52 compared with placebo
时间窗: From baseline to Week 52
The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on the cognitive performance of patients with MCI as measured by ADAS-Cog. ADAS-Cog ranges from 0-85 by summing the number of errors made on each task, so that higher scores indicate worse performance.
次要结局
- Key secondary: Mean change on the Montreal Cognitive Assessment Test (MoCA) total score from baseline to Week 52 compared with placebo(From baseline to Week 52)
- - Mean change on Clinical Dementia Rating - Sum of boxes (CDR-SB) from baseline to Week 52 compared with placebo(From baseline to Week 52)
- Mean change on Mini-Mental State Examination (MMSE) from baseline to Week 52 compared with placebo(From baseline to Week 52)
- - Mean change on Geriatric Depression Scale-15 (GDS-15) from baseline to Week 52 compared with placebo.(From baseline to Week 52)
- - Mean change on Short Anxiety Screening Test (SAST-10) from baseline to Week 52 compared with placebo(From baseline to Week 52)
- - Mean change on Functional Rating Scale of Symptoms of Dementia (FRSSD) from baseline to Week 52 compared with placebo.(From baseline to Week 52)
- - Mean change on Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale for use in Mild Cognitive Impairment (ADCS-MCI-ADL) from baseline to Week 52 compared with placebo.(From baseline to Week 52.)
- - Mean change on Quality of life in Alzheimer's disease (QoL-AD) from baseline to Week 52 compared with placebo.(From baseline to Week 52.)
- - Mean change on - Pittsburgh Sleep Quality Index (PSQI) from baseline to Week 52 compared with placebo.(From baseline to Week 52.)
- - Mean change in LDL-C mg/dL cholesterol from baseline to Week 52 compared with placebo.(From baseline to Week 52)
- - Mean change in HDL-C mg/dL cholesterol from baseline to Week 52 compared with placebo.(From baseline to Week 52)