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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy Men

Intervention / Treatment
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* Dietary Supplement: anthocyanins


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Double blind randomized controlled crossover
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Capsules containing maltodextrin | Dietary Supplement: anthocyanins<br>* Acute intake of capsules<br>|
| Active Comparator: 80 mg ACN<br>Capsules containing 80 mg anthocyanins | Dietary Supplement: anthocyanins<br>* Acute intake of capsules<br>|
| Active Comparator: 160 mg ACN<br>Capsules containing 160 mg anthocyanins | Dietary Supplement: anthocyanins<br>* Acute intake of capsules<br>|
| Active Comparator: 240 mg ACN<br>Capsules containing 240 mg anthocyanins | Dietary Supplement: anthocyanins<br>* Acute intake of capsules<br>|
| Active Comparator: 320 mg ACN<br>Capsules containing 320 mg anthocyanins | Dietary Supplement: anthocyanins<br>* Acute intake of capsules<br>|
| Active Comparator: 480 mg ACN<br>Capsules containing 480 mg anthocyanins | Dietary Supplement: anthocyanins<br>* Acute intake of capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function | Flow-mediated dilation | Changes from baseline to 2 hours postconsumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Automatic measurements | 0 and 2 hours postconsumption |