Metabolic, Vascular and Cognitive Effects of Treatment With Anthocyanins
Primary Purpose
Coronary Disease, Inflammation, Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Anthocyanin
Sponsored by

About this trial
This is an interventional prevention trial for Coronary Disease
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.
Sites / Locations
- Stavanger University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Anthocyanin
Controls
Arm Description
34 patients will receive anthocyanin. We will analyze their blood samples both prior and after taking anthocyanin.
Healthy Controls, 20 persons. Will be giving blood samples at study start and study end.
Outcomes
Primary Outcome Measures
Inflammation as measured by cytokines in blood
IL1, IL6, IL10, TNFa
Effect on blood lipids as measured by serum Levels of Cholesterol, triglycerides, cholesterol metabolites
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
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
Blood levels of vitamin E, vitamin C, vitamin A, total plasma antioxidant capacity, glutathion
Number of participants With adverse events
Active questioning for adverse events
Secondary Outcome Measures
Effects on memory (CERAD memory test)
CERAD memory test, immediate and delayed score
Effects on attention (Trail making A and B)
Trail making A and B
Effects on executive functioning (Stroop test)
Stroop test
Effects on blood pressure
Blood pressure (mm/Hg) in sitting position
Effects on heart rate (ECG)
ECG
Effect on Cardiac output (Blood Levels of natriuretic peptides)
Blood Levels of natriuretic peptides
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02409446
Brief Title
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
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Stavanger HF
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease, Inflammation, Cognitive Impairment
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anthocyanin
Arm Type
Experimental
Arm Description
34 patients will receive anthocyanin. We will analyze their blood samples both prior and after taking anthocyanin.
Arm Title
Controls
Arm Type
No Intervention
Arm Description
Healthy Controls, 20 persons. Will be giving blood samples at study start and study end.
Intervention Type
Dietary Supplement
Intervention Name(s)
Anthocyanin
Other Intervention Name(s)
Medox
Intervention Description
Open pilot study. 35 patients will receive anthocyanin 160 mg x 2 p.o for 16 weeks
Primary Outcome Measure Information:
Title
Inflammation as measured by cytokines in blood
Description
IL1, IL6, IL10, TNFa
Time Frame
16 weeks
Title
Effect on blood lipids as measured by serum Levels of Cholesterol, triglycerides, cholesterol metabolites
Description
Serum Level measurement of Cholesterol, triglycerides, cholesterol metabolites
Time Frame
16 weeks
Title
Effects on oxidative stress as measured by Blood Levels of lipid peroxidation markers, 4-hydroxymenal protein oxydation marker, total protein carbonyl
Description
Blood Levels of lipid peroxidation markers, 4-hydroxymenal protein oxydation marker, total protein carbonyl
Time Frame
16 weeks
Title
Effects on antioxidants as measured by Blood levels of vitamin E, vitamin C, vitamin A, total plasma antioxidant capacity, glutathion
Description
Blood levels of vitamin E, vitamin C, vitamin A, total plasma antioxidant capacity, glutathion
Time Frame
16 weeks
Title
Number of participants With adverse events
Description
Active questioning for adverse events
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Effects on memory (CERAD memory test)
Description
CERAD memory test, immediate and delayed score
Time Frame
16 weeks
Title
Effects on attention (Trail making A and B)
Description
Trail making A and B
Time Frame
16 weeks
Title
Effects on executive functioning (Stroop test)
Description
Stroop test
Time Frame
16 weeks
Title
Effects on blood pressure
Description
Blood pressure (mm/Hg) in sitting position
Time Frame
16 weeks
Title
Effects on heart rate (ECG)
Description
ECG
Time Frame
16 weeks
Title
Effect on Cardiac output (Blood Levels of natriuretic peptides)
Description
Blood Levels of natriuretic peptides
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dag Aarsland
Organizational Affiliation
Helse Stavanger HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stavanger University Hospital
City
Stavanger
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31244884
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. Erratum In: Front Genet. 2021 May 31;12:678504.
Results Reference
derived
Learn more about this trial
Metabolic, Vascular and Cognitive Effects of Treatment With Anthocyanins
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