Metabolic, Vascular and Cognitive Effects of Treatment With Anthocyanins

Inflammation Clinical Trial

Official title:

Metabolic, Vascular and Cognitive Effects of Treatment With Anthocyanins in Older Adults at Risk for Adverse Outcomes - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02409446
• Other study ID #: Antho 030
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: November 2018

Study information

• Verified date: December 2017
• Source: Helse Stavanger HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Coronary Artery Disease
• Coronary Disease
• Inflammation

Intervention

Dietary Supplement:
• Anthocyanin
Open pilot study. 35 patients will receive anthocyanin 160 mg x 2 p.o for 16 weeks

Locations

Country	Name	City	State
Norway	Stavanger University Hospital	Stavanger

Sponsors (1)

Lead Sponsor	Collaborator
Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammation as measured by cytokines in blood	IL1, IL6, IL10, TNFa	16 weeks
Primary	Effect on blood lipids as measured by serum Levels of Cholesterol, triglycerides, cholesterol metabolites	Serum Level measurement of Cholesterol, triglycerides, cholesterol metabolites	16 weeks
Primary	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	16 weeks
Primary	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	16 weeks
Primary	Number of participants With adverse events	Active questioning for adverse events	16 weeks
Secondary	Effects on memory (CERAD memory test)	CERAD memory test, immediate and delayed score	16 weeks
Secondary	Effects on attention (Trail making A and B)	Trail making A and B	16 weeks
Secondary	Effects on executive functioning (Stroop test)	Stroop test	16 weeks
Secondary	Effects on blood pressure	Blood pressure (mm/Hg) in sitting position	16 weeks
Secondary	Effects on heart rate (ECG)	ECG	16 weeks
Secondary	Effect on Cardiac output (Blood Levels of natriuretic peptides)	Blood Levels of natriuretic peptides	16 weeks