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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Stavanger, Norvège
- Stavanger University Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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
Autres noms:
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Aucune intervention: Controls
Healthy Controls, 20 persons.
Will be giving blood samples at study start and study end.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Inflammation as measured by cytokines in blood
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 16 weeks
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Active questioning for adverse events
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16 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Effects on memory (CERAD memory test)
Délai: 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)
Délai: 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)
Délai: 16 weeks
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Stroop test
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16 weeks
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Effects on blood pressure
Délai: 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)
Délai: 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)
Délai: 16 weeks
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Blood Levels of natriuretic peptides
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16 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Dag Aarsland, Helse Stavanger HF
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Antho 030
Plan pour les données individuelles des participants (IPD)
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