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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Stavanger、ノルウェー
- Stavanger University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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
他の名前：
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介入なし：Controls
Healthy Controls, 20 persons.
Will be giving blood samples at study start and study end.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Inflammation as measured by cytokines in blood
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：16 weeks
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Active questioning for adverse events
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16 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Effects on memory (CERAD memory test)
時間枠：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)
時間枠：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)
時間枠：16 weeks
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Stroop test
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16 weeks
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Effects on blood pressure
時間枠：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)
時間枠：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)
時間枠：16 weeks
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Blood Levels of natriuretic peptides
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16 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Dag Aarsland、Helse Stavanger HF
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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