Clinical trial NCT02409446: Metabolic, Vascular and Cognitive Effects of Treatment With Anthocyanins
Official title: Metabolic, Vascular and Cognitive Effects of Treatment With Anthocyanins in Older Adults at Risk for Adverse Outcomes - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Inflammation
Cognitive Impairment
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2015-04-06
Enrollment: 54
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Inflammation as measured by cytokines in blood
timeFrame: 16 weeks
measure: Effect on blood lipids as measured by serum Levels of Cholesterol, triglycerides, cholesterol metabolites
timeFrame: 16 weeks
measure: Effects on oxidative stress as measured by Blood Levels of lipid peroxidation markers, 4-hydroxymenal protein oxydation marker, total protein carbonyl
timeFrame: 16 weeks
measure: Effects on antioxidants as measured by Blood levels of vitamin E, vitamin C, vitamin A, total plasma antioxidant capacity, glutathion
timeFrame: 16 weeks
measure: Number of participants With adverse events
timeFrame: 16 weeks
Secondary outcomes:
measure: Effects on memory (CERAD memory test)
timeFrame: 16 weeks
measure: Effects on attention (Trail making A and B)
timeFrame: 16 weeks
measure: Effects on executive functioning (Stroop test)
timeFrame: 16 weeks
measure: Effects on blood pressure
timeFrame: 16 weeks
measure: Effects on heart rate (ECG)
timeFrame: 16 weeks
measure: Effect on Cardiac output (Blood Levels of natriuretic peptides)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
Study officials:
affiliation: Helse Stavanger HF
name: Dag Aarsland
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bergland AK, Soennesyn H, Dalen I, Rodriguez-Mateos A, Berge RK, Giil LM, Rajendran L, Siow R, Tassotti M, Larsen AI, Aarsland D. Effects of Anthocyanin Supplementation on Serum Lipids, Glucose, Markers of Inflammation and Cognition in Adults With Increased Risk of Dementia - A Pilot Study. Front Genet. 2019 Jun 11;10:536. doi: 10.3389/fgene.2019.00536. eCollection 2019.