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

Status

Completed

Conditions

Intervention / Treatment

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

      • 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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