Healthy Men
Conditions
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.
Interventions
DIETARY_SUPPLEMENTanthocyanins
Acute intake of capsules
Sponsors
Heinrich-Heine University, Duesseldorf
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Double blind randomized controlled crossover
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial function | Changes from baseline to 2 hours postconsumption | Flow-mediated dilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | 0 and 2 hours postconsumption | Automatic measurements |
Other
| Measure | Time frame | Description |
|---|---|---|
| Other Pre-specified Outcome Measures | 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) |
Countries
Germany
Outcome results
None listed