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Dose-Dependent Effects of Anthocyanins on Endothelial Function in Healthy Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118791
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

Brief 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. The present study aimes to investigate whether pure anthocyanin consumption improves endothelial function in healthy individuals and if these effects are dose-dependent.

Condition or disease Intervention/treatment Phase
Healthy Men Dietary Supplement: anthocyanins Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Double blind randomized controlled crossover
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation on Acute Dose-Dependent Effects of Anthocyanins on Endothelial Function
Actual Study Start Date : April 7, 2017
Actual Primary Completion Date : August 8, 2017
Actual Study Completion Date : October 31, 2017

Arm Intervention/treatment
Placebo Comparator: Placebo
Capsules containing maltodextrin
Dietary Supplement: anthocyanins
Acute intake of capsules

Active Comparator: 80 mg ACN
Capsules containing 80 mg anthocyanins
Dietary Supplement: anthocyanins
Acute intake of capsules

Active Comparator: 160 mg ACN
Capsules containing 160 mg anthocyanins
Dietary Supplement: anthocyanins
Acute intake of capsules

Active Comparator: 240 mg ACN
Capsules containing 240 mg anthocyanins
Dietary Supplement: anthocyanins
Acute intake of capsules

Active Comparator: 320 mg ACN
Capsules containing 320 mg anthocyanins
Dietary Supplement: anthocyanins
Acute intake of capsules

Active Comparator: 480 mg ACN
Capsules containing 480 mg anthocyanins
Dietary Supplement: anthocyanins
Acute intake of capsules




Primary Outcome Measures :
  1. Endothelial function [ Time Frame: Changes from baseline to 2 hours postconsumption ]
    Flow-mediated dilation


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: 0 and 2 hours postconsumption ]
    Automatic measurements


Other Outcome Measures:
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118791


Locations
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Germany
Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf
Duesseldorf, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
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Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Principal Investigator, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT03118791    
Other Study ID Numbers: ACND
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No