Metabolic, Vascular and Cognitive Effects of Treatment With Anthocyanins

NCT02409446 | Completed

• 1 other identifier: Antho 030
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Disease; Inflammation; Cognitive Impairment

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Effects on memory (CERAD memory test)

  16 weeks

• Effects on attention (Trail making A and B)

  16 weeks

• Effects on executive functioning (Stroop test)

  16 weeks

• Effects on blood pressure

  16 weeks

• Effects on heart rate (ECG)

  16 weeks

Study Arms (2)

Anthocyanin

EXPERIMENTAL

34 patients will receive anthocyanin. We will analyze their blood samples both prior and after taking anthocyanin.

Dietary Supplement: Anthocyanin

Controls

NO INTERVENTION

Healthy Controls, 20 persons. Will be giving blood samples at study start and study end.

Interventions

Anthocyanin DIETARY_SUPPLEMENT

Open pilot study. 35 patients will receive anthocyanin 160 mg x 2 p.o for 16 weeks

Also known as: Medox

Anthocyanin

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helse Stavanger HF: lead

Study Sites (1)

Stavanger University Hospital

Stavanger, Norway

Location

Related Publications (1)

• 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.

  PMID: 31244884 DERIVED

MeSH Terms

Conditions

Coronary Disease; Inflammation; Cognitive Dysfunction

Interventions

Anthocyanins

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glycosides; Carbohydrates; Pigments, Biological; Biological Factors

Study Officials

• Dag Aarsland

  Helse Stavanger HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: April 6, 2015
• Study Start: April 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2018
• Last Updated: February 18, 2019

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)