Coronary DiseaseNCT02409446
Metabolic, Vascular and Cognitive Effects of Treatment With Anthocyanins
A study testing Anthocyanin in people with Coronary Disease and Inflammation, run by Helse Stavanger HF at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Disease, Inflammation, Cognitive Impairment
- What is being tested?
- Anthocyanin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2015to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Disease, Inflammation, Cognitive Impairment
- Being tested
- Anthocyanin
- Medical subject headings
- Coronary Disease, Inflammation, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnthocyaninDietary supplement
Also called Medox
Open pilot study. 35 patients will receive anthocyanin 160 mg x 2 p.o for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Anthocyanin | Experimental | 34 patients will receive anthocyanin. We will analyze their blood samples both prior and after taking anthocyanin. Receives: Dietary Supplement: Anthocyanin |
| Controls | No intervention | Healthy Controls, 20 persons. Will be giving blood samples at study start and study end. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation as measured by cytokines in blood
IL1, IL6, IL10, TNFa
Measured: 16 weeks
Effect on blood lipids as measured by serum Levels of Cholesterol, triglycerides, cholesterol metabolites
Serum Level measurement of Cholesterol, triglycerides, cholesterol metabolites
Measured: 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
Measured: 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
Measured: 16 weeks
Number of participants With adverse events
Active questioning for adverse events
Measured: 16 weeks
Secondary outcomes (6)
Effects on memory (CERAD memory test)
CERAD memory test, immediate and delayed score
Measured: 16 weeks
Effects on attention (Trail making A and B)
Trail making A and B
Measured: 16 weeks
Effects on executive functioning (Stroop test)
Stroop test
Measured: 16 weeks
Effects on blood pressure
Blood pressure (mm/Hg) in sitting position
Measured: 16 weeks
Effects on heart rate (ECG)
ECG
Measured: 16 weeks
Effect on Cardiac output (Blood Levels of natriuretic peptides)
Blood Levels of natriuretic peptides
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2017
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Dag Aarsland, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409446
- Sponsor's protocol ID
- Antho 030
- Status last verified
- Dec 2017
- First submitted
- 17 Mar 2015
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 31244884
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic, Vascular and Cognitive Effects of Treatment With Anthocyanins in Older Adults at Risk for Adverse Outcomes - a Pilot Study
- ClinicalTrials.gov ID
- NCT02409446
- Acronym / sponsor ID
- Antho 030
- Conditions
- Coronary Disease, Inflammation, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- Apr 2015 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 6 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anthocyanin | Experimental | Dietary Supplement: Anthocyanin34 patients will receive anthocyanin. We will analyze their blood samples both prior and after taking anthocyanin. |
| Controls | No intervention | –Healthy Controls, 20 persons. Will be giving blood samples at study start and study end. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnthocyaninAlso: MedoxOpen pilot study. 35 patients will receive anthocyanin 160 mg x 2 p.o for 16 weeks | Dietary supplement | Anthocyanin |
Primary outcome
Inflammation as measured by cytokines in blood
Time frame: 16 weeks
IL1, IL6, IL10, TNFa
Effect on blood lipids as measured by serum Levels of Cholesterol, triglycerides, cholesterol metabolites
Time frame: 16 weeks
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
Time frame: 16 weeks
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
Time frame: 16 weeks
Blood levels of vitamin E, vitamin C, vitamin A, total plasma antioxidant capacity, glutathion
Number of participants With adverse events
Time frame: 16 weeks
Active questioning for adverse events
6 secondary outcomes
Effects on memory (CERAD memory test)
Time frame: 16 weeks
Effects on attention (Trail making A and B)
Time frame: 16 weeks
Effects on executive functioning (Stroop test)
Time frame: 16 weeks
Effects on blood pressure
Time frame: 16 weeks
Effects on heart rate (ECG)
Time frame: 16 weeks
Effect on Cardiac output (Blood Levels of natriuretic peptides)
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Derived from this study: PubMed 31244884Bergland 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dag Aarsland principal investigator
Helse Stavanger HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anthocyanin in people with Coronary Disease and Inflammation, run by Helse Stavanger HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammation as measured by cytokines in blood (time frame: 16 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02409446, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019; AzTrials last refreshed its copy on 7 Nov 2026.