Clinical trial NCT03118791: Dose-Dependent Effects of Anthocyanins on Endothelial Function in Healthy Men
Official title: Investigation on Acute Dose-Dependent Effects of Anthocyanins on Endothelial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Men
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double blind randomized controlled crossover
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Endothelial function
timeFrame: Changes from baseline to 2 hours postconsumption
Secondary outcomes:
measure: Blood pressure
timeFrame: 0 and 2 hours postconsumption
Other outcomes:
measure: Other Pre-specified Outcome Measures
timeFrame: 0 and 2 hours postconsumption
Locations:
city: Duesseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf
Study officials:
References: