- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03118791
Dose-Dependent Effects of Anthocyanins on Endothelial Function in Healthy Men
November 8, 2017 updated by: Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Duesseldorf, Germany, 40225
- Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Capsules containing maltodextrin
|
Acute intake of capsules
|
Active Comparator: 80 mg ACN
Capsules containing 80 mg anthocyanins
|
Acute intake of capsules
|
Active Comparator: 160 mg ACN
Capsules containing 160 mg anthocyanins
|
Acute intake of capsules
|
Active Comparator: 240 mg ACN
Capsules containing 240 mg anthocyanins
|
Acute intake of capsules
|
Active Comparator: 320 mg ACN
Capsules containing 320 mg anthocyanins
|
Acute intake of capsules
|
Active Comparator: 480 mg ACN
Capsules containing 480 mg anthocyanins
|
Acute intake of capsules
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endothelial function
Time Frame: Changes from baseline to 2 hours postconsumption
|
Flow-mediated dilation
|
Changes from baseline to 2 hours postconsumption
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: 0 and 2 hours postconsumption
|
Automatic measurements
|
0 and 2 hours postconsumption
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Other Pre-specified Outcome Measures
Time Frame: 0 and 2 hours postconsumption
|
Plasma (poly)phenol metabolites measured by ultra-performance liquid chromatography quadrupole time of flight mass spectrometry (UPLC-Q-TOF MS)
|
0 and 2 hours postconsumption
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 7, 2017
Primary Completion (Actual)
August 8, 2017
Study Completion (Actual)
October 31, 2017
Study Registration Dates
First Submitted
April 7, 2017
First Submitted That Met QC Criteria
April 12, 2017
First Posted (Actual)
April 18, 2017
Study Record Updates
Last Update Posted (Actual)
November 9, 2017
Last Update Submitted That Met QC Criteria
November 8, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- ACND
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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