Skip to main content
Clinical Trials/NCT03118791
NCT03118791
Completed
Not Applicable

Investigation on Acute Dose-Dependent Effects of Anthocyanins on Endothelial Function

Heinrich-Heine University, Duesseldorf1 site in 1 country10 target enrollmentApril 7, 2017
ConditionsHealthy Men

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Men
Sponsor
Heinrich-Heine University, Duesseldorf
Enrollment
10
Locations
1
Primary Endpoint
Endothelial function
Status
Completed
Last Updated
8 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
April 7, 2017
End Date
October 31, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Sponsor
Heinrich-Heine University, Duesseldorf
Responsible Party
Principal Investigator
Principal Investigator

Klinik für Kardiologie, Pneumologie und Angiologie

Principal Investigator

Heinrich-Heine University, Duesseldorf

Eligibility 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)

Outcomes

Primary Outcomes

Endothelial function

Time Frame: Changes from baseline to 2 hours postconsumption

Flow-mediated dilation

Secondary Outcomes

  • Blood pressure(0 and 2 hours postconsumption)

Study Sites (1)

Loading locations...

Similar Trials