Healthy MenNCT03118791
Dose-Dependent Effects of Anthocyanins on Endothelial Function in Healthy Men
A study testing anthocyanins in people with Healthy Men, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Anthocyanins are a subclass of (poly)phenols very abundant in berries and red grapes. Increasing evidence from human epidemiological and dietary intervention studies suggests that anthocyanins may have cardiovascular health benefits. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Men
- What is being tested?
- anthocyanins
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 7 Apr 2017to 31 Oct 2017
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men aged 18-45 years old
- Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study - subjects are able to understand the nature of the study
- able to give signed written informed consent
- signed written infomred consent form
- healthy male subjects (no clinical signs or symptoms of CVD.
Who cannot join
- cardiovascular disease, acute inflammation, cardiac arrhythmia, renal failure, heart failure (NYHA II-IV), diabetes mellitus, 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
Official title: Investigation on Acute Dose-Dependent Effects of Anthocyanins on Endothelial Function
Anthocyanins are a subclass of (poly)phenols very abundant in berries and red grapes. Increasing evidence from human epidemiological and dietary intervention studies suggests that anthocyanins may have cardiovascular health benefits. The present study aimes to investigate whether pure anthocyanin consumption improves endothelial function in healthy individuals and if these effects are dose-dependent.
Read the detailed description
Anthocyanins are a subclass of (poly)phenols very abundant in berries and red grapes. Increasing evidence from human epidemiological and dietary intervention studies suggests that anthocyanins may have cardiovascular health benefits. A double blind randomized controlled crossover, dose-response study will be conducted in 10 young healthy men. On 6 different days, subjects will consume capsules containing 0, 80, 160, 240, 320 and 480 mg of purified anthocyanins with a one-week wash-out period. Flow-mediated dilation (FMD) and blood pressure will be measured at baseline and at 2 and 6 h after consumption. Blood samples will also be taken and quantification of plasma anthocyanin metabolites using UPLC-Q-TOF-MS will be performed. The aim is to investigate whether purified anthocyanins are able to increase FMD at 2h and 6h post consumption and whether these effects correlate with anthocyanin- derived phenolic acids quantified in the plasma.
- Conditions
- Healthy Men
- Being tested
- anthocyanins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anthocyaninsDietary supplement
Acute intake of capsules
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Capsules containing maltodextrin Receives: Dietary Supplement: anthocyanins |
| 80 mg ACN | Active comparator | Capsules containing 80 mg anthocyanins Receives: Dietary Supplement: anthocyanins |
| 160 mg ACN | Active comparator | Capsules containing 160 mg anthocyanins Receives: Dietary Supplement: anthocyanins |
| 240 mg ACN | Active comparator | Capsules containing 240 mg anthocyanins Receives: Dietary Supplement: anthocyanins |
| 320 mg ACN | Active comparator | Capsules containing 320 mg anthocyanins Receives: Dietary Supplement: anthocyanins |
| 480 mg ACN | Active comparator | Capsules containing 480 mg anthocyanins Receives: Dietary Supplement: anthocyanins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Flow-mediated dilation
Measured: Changes from baseline to 2 hours postconsumption
Secondary outcomes (1)
Blood pressure
Automatic measurements
Measured: 0 and 2 hours postconsumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start7 Apr 2017
- Primary completion8 Aug 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy MenStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double blind randomized controlled crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118791
- Sponsor's protocol ID
- ACND
- Status last verified
- Nov 2017
- First submitted
- 7 Apr 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on Acute Dose-Dependent Effects of Anthocyanins on Endothelial Function
- ClinicalTrials.gov ID
- NCT03118791
- Acronym / sponsor ID
- ACND
- Conditions
- Healthy Men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 18 Apr 2017 (actual)
- 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 a subclass of (poly)phenols very abundant in berries and red grapes. Increasing evidence from human epidemiological and dietary intervention studies suggests that anthocyanins may have cardiovascular health benefits. The present study aimes to investigate whether pure anthocyanin consumption improves endothelial function in healthy individuals and if these effects are dose-dependent.
Detailed description
Anthocyanins are a subclass of (poly)phenols very abundant in berries and red grapes. Increasing evidence from human epidemiological and dietary intervention studies suggests that anthocyanins may have cardiovascular health benefits. A double blind randomized controlled crossover, dose-response study will be conducted in 10 young healthy men. On 6 different days, subjects will consume capsules containing 0, 80, 160, 240, 320 and 480 mg of purified anthocyanins with a one-week wash-out period. Flow-mediated dilation (FMD) and blood pressure will be measured at baseline and at 2 and 6 h after consumption. Blood samples will also be taken and quantification of plasma anthocyanin metabolites using UPLC-Q-TOF-MS will be performed. The aim is to investigate whether purified anthocyanins are able to increase FMD at 2h and 6h post consumption and whether these effects correlate with anthocyanin- derived phenolic acids quantified in the plasma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Double blind randomized controlled crossover
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: anthocyaninsCapsules containing maltodextrin |
| 80 mg ACN | Active comparator | Dietary Supplement: anthocyaninsCapsules containing 80 mg anthocyanins |
| 160 mg ACN | Active comparator | Dietary Supplement: anthocyaninsCapsules containing 160 mg anthocyanins |
| 240 mg ACN | Active comparator | Dietary Supplement: anthocyaninsCapsules containing 240 mg anthocyanins |
| 320 mg ACN | Active comparator | Dietary Supplement: anthocyaninsCapsules containing 320 mg anthocyanins |
| 480 mg ACN | Active comparator | Dietary Supplement: anthocyaninsCapsules containing 480 mg anthocyanins |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy men aged 18-45 years old
- Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study - subjects are able to understand the nature of the study
- able to give signed written informed consent
- signed written infomred consent form
- healthy male subjects (no clinical signs or symptoms of CVD.
Key exclusion criteria (1 listed)
- cardiovascular disease, acute inflammation, cardiac arrhythmia, renal failure, heart failure (NYHA II-IV), diabetes mellitus, C-reactive protein > 0.5 mg/dL, malignant disease, hypotension (≤100 / 60 mm Hg)
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 |
|---|---|---|
| anthocyaninsAcute intake of capsules | Dietary supplement | 160 mg ACN, 240 mg ACN, 320 mg ACN, 480 mg ACN, 80 mg ACN, Placebo |
Primary outcome
Endothelial function
Time frame: Changes from baseline to 2 hours postconsumption
Flow-mediated dilation
1 secondary outcome
Blood pressure
Time frame: 0 and 2 hours postconsumption
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 9 Nov 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anthocyanins in people with Healthy Men, 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 5 inclusion and 1 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 9 Nov 2017. 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: Changes from baseline to 2 hours postconsumption). 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 9 Nov 2017.