Effects of Hydroxytyrosol-Rich Olive Polyphenol Dietary Supplement Combined With Mediterranean Diet Adherence on the Cognitive Health of Patients With Mild Cognitive Impairment (MEDIPHENO-HT)
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
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.
研究概览
地位
招聘中
条件
研究类型
介入性
注册 (估计的)
141
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Magda Tsolaki, Professor Emeritus, MD, PhD
- 电话号码：+30 2310316143
- 邮箱：tsolakim1@gmail.com
学习地点
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Central Macedonia
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Thessaloniki、Central Macedonia、希腊、54250
- 招聘中
- Palliative Care Centre "Panagia Glykofilousa", Greek Association of Alzheimer's Disease and Related Disorders, Plastira 65, Thessaloniki 54250, Greece.
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接触：
- Magda Tsolaki, Professor Emeritus, MD, PhD
- 电话号码：+30 2310316143
- 邮箱：tsolakim1@gmail.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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 ≤ 26. Or
- MMSE (Mini-Mental State Examination) score of ≥26 and ≤ 28.
- No active suicide ideation based on the Columbia-Suicide Severity Rating Scale.
- Absence of severe depressive symptomatology based on the Geriatric Depression Scale-15.
- Not using any laxative drugs for at least three days prior to the screening visit.
- Information about APOE status
Exclusion Criteria:
- 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/ m2.
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Active Arm - Low Dose
Low dose: 8 drops (20mg of polyphenols) + Mediterranean Diet instructions
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This is a prospective, randomised, double-blind, three-arm, placebo-controlled with 1:1:1 randomisation and 52-week follow-up trial.
The MEDIPHENO-HTrial study will enrol patients within the Mild Cognitive Impairment spectrum related to AD and non-AD type pathologies.
Participants will be randomised to receive either 8 drops of the active HT-high phenolic supplement, or 16 drops of the active HT-high phenolic supplement or 8 drops of the matching placebo.
The Mediterranean diet adherence support will be delivered identically to all groups to reduce dietary confounding.
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实验性的：Experimental Arm - High Dose
High dose: 16 drops (40mg of polyphenols) + Mediterranean Diet instructions
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This is a prospective, randomised, double-blind, three-arm, placebo-controlled with 1:1:1 randomisation and 52-week follow-up trial.
The MEDIPHENO-HTrial study will enrol patients within the Mild Cognitive Impairment spectrum related to AD and non-AD type pathologies.
Participants will be randomised to receive either 8 drops of the active HT-high phenolic supplement, or 16 drops of the active HT-high phenolic supplement or 8 drops of the matching placebo.
The Mediterranean diet adherence support will be delivered identically to all groups to reduce dietary confounding.
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安慰剂比较：Placebo Comparator Arm
Placebo 8 drops + Mediterranean Diet instructions
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This is a prospective, randomised, double-blind, three-arm, placebo-controlled with 1:1:1 randomisation and 52-week follow-up trial.
The MEDIPHENO-HTrial study will enrol patients within the Mild Cognitive Impairment spectrum related to AD and non-AD type pathologies.
Participants will be randomised to receive either 8 drops of the active HT-high phenolic supplement, or 16 drops of the active HT-high phenolic supplement or 8 drops of the matching placebo.
The Mediterranean diet adherence support will be delivered identically to all groups to reduce dietary confounding.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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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
大体时间：From baseline to Week 52
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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.
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From baseline to Week 52
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Key secondary: Mean change on the Montreal Cognitive Assessment Test (MoCA) total score from baseline to Week 52 compared with placebo
大体时间：From baseline to Week 52
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The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on the cognitive performance of patients with MCI as measured by MoCA.
The total possible score for the test is 30 points by summing the number of correct responses given in each task, so higher scores indicate better performance.
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From baseline to Week 52
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- Mean change on Clinical Dementia Rating - Sum of boxes (CDR-SB) from baseline to Week 52 compared with placebo
大体时间：From baseline to Week 52
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- The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on the CDR-SB, which ranges from 0 to 18, and is calculated by summing the ratings across each of the six domains (memory, orientation, judgment and problem-solving, community affairs, home and hobbies, and personal care), with higher scores indicating greater impairment.
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From baseline to Week 52
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Mean change on Mini-Mental State Examination (MMSE) from baseline to Week 52 compared with placebo
大体时间：From baseline to Week 52
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The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on the MMSE, which is a 30-point brief screening measure of cognitive status.
Higher scores indicate better performance.
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From baseline to Week 52
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- Mean change on Geriatric Depression Scale-15 (GDS-15) from baseline to Week 52 compared with placebo.
大体时间：From baseline to Week 52
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- The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on GDS-15, which consists of 15 items and is used to screen for depression in adults.
GDS-15 assess mental health based on feelings over the past week, with higher scores on the measure denoting more severe levels of depressive symptoms.
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From baseline to Week 52
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- Mean change on Short Anxiety Screening Test (SAST-10) from baseline to Week 52 compared with placebo
大体时间：From baseline to Week 52
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The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on SAST-10, which is a brief questionnaire designed to assess anxiety.
SAST-10 scores range from 10 to 40, with higher scores on the measure denoting more severe levels of anxiety symptoms.
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From baseline to Week 52
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- Mean change on Functional Rating Scale of Symptoms of Dementia (FRSSD) from baseline to Week 52 compared with placebo.
大体时间：From baseline to Week 52
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The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on FRSSD.
The scale ranges from 0 (fully independent) to 42 (fully dependent), with lower scores indicating better daily functioning.
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From baseline to Week 52
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- 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.
大体时间：From baseline to Week 52.
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The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on ADCS-MCI-ADL, which is a brief questionnaire designed to capture functional abilities (with recall "In the past 4 weeks").
The 18-item ADCS-ADL-MCI is scored from 0 to 53 based on the subject's degree of independence in performing specific tasks.
Lower scores on the measure denote more substantial impairment.
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From baseline to Week 52.
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- Mean change on Quality of life in Alzheimer's disease (QoL-AD) from baseline to Week 52 compared with placebo.
大体时间：From baseline to Week 52.
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The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on QoL-AD, which is a brief 13-item questionnaire designed to assess quality of life.
QoL-AD range from 13 to 52, with higher scores indicating better quality of life.
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From baseline to Week 52.
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- Mean change on - Pittsburgh Sleep Quality Index (PSQI) from baseline to Week 52 compared with placebo.
大体时间：From baseline to Week 52.
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The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on PSQI, which is a questionnaire designed to assess Sleep quality.
PSQI range from 0 to 21, with higher scores indicating poor sleep.
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From baseline to Week 52.
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- Mean change in LDL-C mg/dL cholesterol from baseline to Week 52 compared with placebo.
大体时间：From baseline to Week 52
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The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on LDL-C mg/dL cholesterol.
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From baseline to Week 52
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- Mean change in HDL-C mg/dL cholesterol from baseline to Week 52 compared with placebo.
大体时间：From baseline to Week 52
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The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on HDL-C mg/dL cholesterol.
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From baseline to Week 52
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Mean percentage change in plasma phosphorylated tau 217 (p-tau217) pg/mL from baseline to Week 52 compared with placebo.
大体时间：From baseline to Week 52
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Exploratory analyses will include blood biomarkers, p-tau217 pg/mL.
Mean percentage change in plasma p-tau217 pg/mL from baseline to Week 52 compared with placebo.
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From baseline to Week 52
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Mean percentage change in plasma levels of beta-amyloid 1-42 (Aβ 1-42) pg/mL from baseline to Week 52 compared with placebo.
大体时间：From baseline to Week 52
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Exploratory analyses will include blood biomarkers, Aβ 1-42 pg/mL.
Mean percentage change in plasma levels of Aβ 1-42 pg/mL from baseline to Week 52 compared with placebo.
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From baseline to Week 52
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Mean percentage change in plasma Glial Fibrillary Acidic Protein (GFAP) pg/mL concentration from baseline to Week 52 compared with placebo.
大体时间：From baseline to Week 52
|
Exploratory analyses will include blood biomarkers, GFAP pg/mL.
Mean percentage change in plasma GFAP pg/mL concentration from baseline to Week 52 compared with placebo.
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From baseline to Week 52
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Vilma Chalili、School of Medicine, Aristotle University of Thessaloniki
- 学习椅：Magda Tsolaki、First Department of Neurology, Faculty of Health Sciences, School of Medicine, Aristotle University of Thessaloniki
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年3月31日
初级完成 (估计的)
2026年12月1日
研究完成 (估计的)
2026年12月1日
研究注册日期
首次提交
2026年6月17日
首先提交符合 QC 标准的
2026年6月22日
首次发布 (实际的)
2026年6月29日
研究记录更新
最后更新发布 (实际的)
2026年6月30日
上次提交的符合 QC 标准的更新
2026年6月28日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.