Post-menopausal WomenAnthocyaninsNCT02517801
Investigation on the Sustained Effect of Anthocyanins on Endothelial Function in Postmenopausal Women
A study testing Anthocyanin capsules in people with Post-menopausal Women, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Anthocyanins are the most common polyphenols in berries and red wine, along with other flavonoids, phenolic acids, minerals and vitamins. Anthocyanins are extensively metabolized and they are transformed into glucuronides and phenolic acids. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-menopausal Women
- What is being tested?
- Anthocyanin capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to Sep 2015
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Post-menopausal female subjects without clinical signs or symptoms of cardiovascular disease, no menstruation cycle for more than 1 year, postmenopausal status conformed by female hormone analysis
- > 50 years
Who cannot join
- cardiovascular disease
- acute inflammation
- cardiac arrhythmia
- renal failure
- heart failure (NYHA II-IV)
- diabetes mellitus
Show all 9Show fewer
- C-reactive protein > 0.5 mg/dL
- malignant disease
- hypotension (≤100 / 60 mm Hg)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf
Düsseldorf, 40225
About this study
Anthocyanins are the most common polyphenols in berries and red wine, along with other flavonoids, phenolic acids, minerals and vitamins. Anthocyanins are extensively metabolized and they are transformed into glucuronides and phenolic acids. The investigators have recently shown that the acute consumption of blueberries leads to an increase in endothelium-dependent vasodilation measured as flow-mediated dilatation (FMD) in young male volunteers. There were significant correlations of these effects with the plasma concentration of phenolic acids and anthocyanin metabolites. Therefore, the present study aims at understanding to which extent the anthocyanins contained in berries are related with positive effects in endothelial function. A large part of the absorbed anthocyanin circulate in the blood in as methyl, glucuronyl and sulfate metabolites, as well as phenolic acids. The formation of these metabolites begins right as early as 2h after consumption due to metabolism at the small intestine and a second plasmatic peak occurs around 6h due the metabolism of colonic bacteria. Whether and which metabolites are associated with biological effects and the mechanisms underlying this effect remains unclear.
- Conditions
- Post-menopausal Women
- Being tested
- Anthocyanin capsules, placebo capsules
- Keywords
- anthocyanins, Post-menopausal women, endothelial function, vascular function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anthocyanin capsulesDietary supplement
Chronic intake of 2 capsules for 30 days (2x daily). Capsules with 80 mg of anthocyanins.
placebo capsulesDietary supplement
Chronic intake of 2 capsules for 30 days (2x daily). 2 capsules devoid of anthocyanins.
| Study group | Role | What they receive |
|---|---|---|
| Anthocyanin capsules | Experimental | Chronic intake of 2 capsules for 30 days (2x daily) Receives: Dietary Supplement: Anthocyanin capsules |
| placebo capsules | Placebo comparator | Chronic intake of 2 capsules for 30 days (2x daily) Receives: Dietary Supplement: placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Measured by Flow mediated dilation (FMD) at 0 and 2 hours postconsumption
Measured: Baseline and on day 30
Secondary outcomes (4)
Pulse wave velocity
measured by SphygmoCor at 0 and 2 hours postconsumption
Measured: Baseline and on day 30
Central blood pressure
measured by SphygmoCor at 0 and 2 hours postconsumption
Measured: Baseline and on day 30
Heart rate
measured by SphygmoCor at 0 and 2 hours postconsumption
Measured: Baseline and on day 30
Ambulatory blood pressure
measured by Tonoport V , 24 h continuous measurement postconsumption
Measured: Baseline and on day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-menopausal WomenStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Ana Rodriguez-Mateos, PhD, Principal investigator, Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital DuesseldorfChristian Heiss, MD, Study chair, Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517801
- Sponsor's protocol ID
- Anthocyanins
- Acronym
- Anthocyanins
- Status last verified
- Nov 2015
- First submitted
- 8 Jul 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Sustained Effect of Anthocyanins on Endothelial Function in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT02517801
- Acronym / sponsor ID
- Anthocyanins / Anthocyanins
- Conditions
- Post-menopausal Women
- Keywords
- anthocyanins, Post-menopausal women, endothelial function, vascular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 7 Aug 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.
Anthocyanins are the most common polyphenols in berries and red wine, along with other flavonoids, phenolic acids, minerals and vitamins. Anthocyanins are extensively metabolized and they are transformed into glucuronides and phenolic acids. The investigators have recently shown that the acute consumption of blueberries leads to an increase in endothelium-dependent vasodilation measured as flow-mediated dilatation (FMD) in young male volunteers. There were significant correlations of these effects with the plasma concentration of phenolic acids and anthocyanin metabolites. Therefore, the present study aims at understanding to which extent the anthocyanins contained in berries are related with positive effects in endothelial function. A large part of the absorbed anthocyanin circulate in the blood in as methyl, glucuronyl and sulfate metabolites, as well as phenolic acids. The formation of these metabolites begins right as early as 2h after consumption due to metabolism at the small intestine and a second plasmatic peak occurs around 6h due the metabolism of colonic bacteria. Whether and which metabolites are associated with biological effects and the mechanisms underlying this effect remains unclear.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anthocyanin capsules | Experimental | Dietary Supplement: Anthocyanin capsulesChronic intake of 2 capsules for 30 days (2x daily) |
| placebo capsules | Placebo comparator | Dietary Supplement: placebo capsulesChronic intake of 2 capsules for 30 days (2x daily) |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Post-menopausal female subjects without clinical signs or symptoms of cardiovascular disease, no menstruation cycle for more than 1 year, postmenopausal status conformed by female hormone analysis
- > 50 years
Key exclusion criteria (9 listed)
- cardiovascular disease
- acute inflammation
- cardiac arrhythmia
- renal failure
- heart failure (NYHA II-IV)
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 |
|---|---|---|
| Anthocyanin capsulesChronic intake of 2 capsules for 30 days (2x daily). Capsules with 80 mg of anthocyanins. | Dietary supplement | Anthocyanin capsules |
| placebo capsulesChronic intake of 2 capsules for 30 days (2x daily). 2 capsules devoid of anthocyanins. | Dietary supplement | placebo capsules |
Primary outcome
Endothelial function
Time frame: Baseline and on day 30
Measured by Flow mediated dilation (FMD) at 0 and 2 hours postconsumption
4 secondary outcomes
Pulse wave velocity
Time frame: Baseline and on day 30
Central blood pressure
Time frame: Baseline and on day 30
Heart rate
Time frame: Baseline and on day 30
Ambulatory blood pressure
Time frame: Baseline and on day 30
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 3 Nov 2015.
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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.
Ana Rodriguez-Mateos, PhD principal investigator
Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf
Christian Heiss, MD study chair
Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf
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 capsules in people with Post-menopausal Women, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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 2 inclusion and 9 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 3 Nov 2015. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
Endothelial function (time frame: Baseline and on day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2015.