Metabolic, Vascular and Cognitive Effects of Treatment With Anthocyanins in Older Adults at Risk for Adverse Outcomes - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Inflammation as measured by cytokines in blood
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Anthocyanin
34 patients will receive anthocyanin. We will analyze their blood samples both prior and after taking anthocyanin.
干预措施: Anthocyanin (Dietary Supplement)
Controls
Healthy Controls, 20 persons. Will be giving blood samples at study start and study end.
结局指标
主要结局
Inflammation as measured by cytokines in blood
时间窗: 16 weeks
IL1, IL6, IL10, TNFa
Effect on blood lipids as measured by serum Levels of Cholesterol, triglycerides, cholesterol metabolites
时间窗: 16 weeks
Serum Level measurement of Cholesterol, triglycerides, cholesterol metabolites
Effects on oxidative stress as measured by Blood Levels of lipid peroxidation markers, 4-hydroxymenal protein oxydation marker, total protein carbonyl
时间窗: 16 weeks
Blood Levels of lipid peroxidation markers, 4-hydroxymenal protein oxydation marker, total protein carbonyl
Effects on antioxidants as measured by Blood levels of vitamin E, vitamin C, vitamin A, total plasma antioxidant capacity, glutathion
时间窗: 16 weeks
Blood levels of vitamin E, vitamin C, vitamin A, total plasma antioxidant capacity, glutathion
Number of participants With adverse events
时间窗: 16 weeks
Active questioning for adverse events
次要结局
- Effects on attention (Trail making A and B)(16 weeks)
- Effects on executive functioning (Stroop test)(16 weeks)
- Effect on Cardiac output (Blood Levels of natriuretic peptides)(16 weeks)
- Effects on memory (CERAD memory test)(16 weeks)
- Effects on blood pressure(16 weeks)
- Effects on heart rate (ECG)(16 weeks)