Metabolic, Vascular and Cognitive Effects of Treatment With Anthocyanins
Metabolic, Vascular and Cognitive Effects of Treatment With Anthocyanins in Older Adults at Risk for Adverse Outcomes - a Pilot Study
The purpose of this study is to examine weather treatment with anthocyanins will affect lipid profile, markers of inflammation and oxidative stress in addition to antioxidative level in serum to the better in persons with increased risk of dementia.
The purpose of this study is to examine weather treatment with anthocyanins will increase the score of relevant tests of cognitive function.
The investigators will do an open pilot study where patients receive anthocyanin for 16 weeks. 34 patients are expected to be included.
In addition we will include 20 healthy Controls.
研究概览
详细说明
Design, method and material:
The investigators will first do an open pilot study where 30 people will receive anthocyanins for 16 weeks.
The investigators aim to recruit persons with increased risk of cognitive reduction: persons over 50 years with stable coronary heart disease (CAD) from the cardiology department Stavanger University Hospital. In addition will persons with mild cognitive impairment or mild dementia be included from the memory outpatient clinic, Stavanger University Hospital.
Blood will be taken by venepuncture by an experienced nurse, centrifuged and handled in according to standardized procedures.
The patients will be tested in relevant tests of cognitive function at inclusion and after 16 weeks. At inclusion the patients will be tested in Mini Mental State Examination (MMSE) and Geriatric depression scale (GDS) to make sure that the patients meet the inclusion criteria. At inclusion and after 16 weeks the patients will be tested in Word List Memory Word List Recall Word List Recognition, Trail Making Test A + B and Stroop Word and Colour test.
From the healthy controls blood will be taken at inclusion and study end.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Stavanger、挪威
- Stavanger University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age above 50 years and coronary suspect chest pain with angiographically CAD without physiologically stenosis
- Mild cognitive impairment (ICD 10) or mild dementia, defined as fulfilling the dementia criteria (ICD 10) but with an MMSE score of 24 or higher.
- Stable medical treatment for the last 3 months.
Exclusion Criteria:
- Moderate to severe dementia (MMSE < 24)
- Clinical significant depression (GDS-15 score of 7 or higher)
- Unstable coronary heart disease
- Heart failure in need of treatment
- Inflammatory illnesses such at rheumatoid arthritis etc.
- Another severe illness with < 5 year expected survival time.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Anthocyanin
34 patients will receive anthocyanin.
We will analyze their blood samples both prior and after taking anthocyanin.
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Open pilot study.
35 patients will receive anthocyanin 160 mg x 2 p.o for 16 weeks
其他名称：
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无干预：Controls
Healthy Controls, 20 persons.
Will be giving blood samples at study start and study end.
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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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Inflammation as measured by cytokines in blood
大体时间：16 weeks
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IL1, IL6, IL10, TNFa
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16 weeks
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Effect on blood lipids as measured by serum Levels of Cholesterol, triglycerides, cholesterol metabolites
大体时间：16 weeks
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Serum Level measurement of Cholesterol, triglycerides, cholesterol metabolites
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16 weeks
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Effects on oxidative stress as measured by Blood Levels of lipid peroxidation markers, 4-hydroxymenal protein oxydation marker, total protein carbonyl
大体时间：16 weeks
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Blood Levels of lipid peroxidation markers, 4-hydroxymenal protein oxydation marker, total protein carbonyl
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16 weeks
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Effects on antioxidants as measured by Blood levels of vitamin E, vitamin C, vitamin A, total plasma antioxidant capacity, glutathion
大体时间：16 weeks
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Blood levels of vitamin E, vitamin C, vitamin A, total plasma antioxidant capacity, glutathion
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16 weeks
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Number of participants With adverse events
大体时间：16 weeks
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Active questioning for adverse events
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16 weeks
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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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Effects on memory (CERAD memory test)
大体时间：16 weeks
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CERAD memory test, immediate and delayed score
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16 weeks
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Effects on attention (Trail making A and B)
大体时间：16 weeks
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Trail making A and B
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16 weeks
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Effects on executive functioning (Stroop test)
大体时间：16 weeks
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Stroop test
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16 weeks
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Effects on blood pressure
大体时间：16 weeks
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Blood pressure (mm/Hg) in sitting position
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16 weeks
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Effects on heart rate (ECG)
大体时间：16 weeks
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ECG
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16 weeks
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Effect on Cardiac output (Blood Levels of natriuretic peptides)
大体时间：16 weeks
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Blood Levels of natriuretic peptides
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16 weeks
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合作者和调查者
调查人员
- 首席研究员：Dag Aarsland、Helse Stavanger HF
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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