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.

Study Overview

• Status: Completed
• Conditions: Coronary Disease; Inflammation; Cognitive Impairment
• Intervention / Treatment: Dietary supplement: Anthocyanin

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Stavanger, Norway
    • Stavanger University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anthocyanin; 34 patients will receive anthocyanin. We will analyze their blood samples both prior and after taking anthocyanin.	Dietary supplement: Anthocyanin; Open pilot study. 35 patients will receive anthocyanin 160 mg x 2 p.o for 16 weeks; Other Names: Medox
No Intervention: Controls; Healthy Controls, 20 persons. Will be giving blood samples at study start and study end.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammation as measured by cytokines in blood	IL1, IL6, IL10, TNFa	16 weeks
Effect on blood lipids as measured by serum Levels of Cholesterol, triglycerides, cholesterol metabolites	Serum Level measurement of Cholesterol, triglycerides, cholesterol metabolites	16 weeks
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
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
Number of participants With adverse events	Active questioning for adverse events	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects on memory (CERAD memory test)	CERAD memory test, immediate and delayed score	16 weeks
Effects on attention (Trail making A and B)	Trail making A and B	16 weeks
Effects on executive functioning (Stroop test)	Stroop test	16 weeks
Effects on blood pressure	Blood pressure (mm/Hg) in sitting position	16 weeks
Effects on heart rate (ECG)	ECG	16 weeks
Effect on Cardiac output (Blood Levels of natriuretic peptides)	Blood Levels of natriuretic peptides	16 weeks

Collaborators and Investigators

• Sponsor: Helse Stavanger HF
• Investigators: Principal Investigator: Dag Aarsland, Helse Stavanger HF

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: March 17, 2015
• First Submitted That Met QC Criteria: April 3, 2015
• First Posted (Estimate): April 6, 2015

Study Record Updates

• Last Update Posted (Actual): February 18, 2019
• Last Update Submitted That Met QC Criteria: February 15, 2019
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Inflammation
• Other Study ID Numbers: Antho 030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO