Anthocyanin-rich Blackcurrant and Vascular Function

Study Overview
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Brief Summary
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Regular consumption of fruits and vegetables may improve human health and reduce the risk of chronic diseases, such as heart disease, certain cancers and type 2 diabetes, but the active components and the underlying mechanisms are poorly understood. Berry fruits are abundant in anthocyanins and this study aims to test the hypothesis that ingestion of an anthocyanin-rich blackcurrant beverage will improve markers of cardiovascular health (health of blood vessels, inflammation and platelet function). Further, the study will investigate the anthocyanin bioavailability from the blackcurrant beverage.

Official Title
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Effects of an Anthocyanin-rich Blackcurrant Beverage on Cardiovascular Function

Conditions
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Vascular Stiffness, Inflammation

Intervention / Treatment
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* Other: Beverage: Spray dried blackcurrant powder dissolved in water
* Other: Beverage: Placebo (sucrose, glucose, fructose, maltodextrin, malic acid, citric acid, vitamin C, artificial blackcurrant flavouring and low-nitrate water)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 30-55 years Non-smoker BMI between 20 - 30 kg/m2 Generally healthy as established by a 'health and lifestyle' questionnaire and a screening blood sample Blood pressure < 140/90mmHg Total cholesterol < 6.2 mmol/L Fasting glucose < 7.0 mmol/L Exclusion Criteria: Diabetes mellitus Heart problems, stroke, vascular disease Inflammatory disease Kidney, liver, pancreas or gastrointestinal diseases Medication for hyperlipidaemia, hypertension, hypercoagulation, inflammatory conditions Asthma Allergies Smokers (social smokers who agree to abstain for 1 month before and during the study not excluded) Taking phytochemical, antioxidant or fish oil supplements (unless willing to stop for the study period) Taking aspirin > 2 times per month and unwilling to abstain from aspirin ingestion for 14 days prior each study visit History of alcohol misuse Consumption of alcohol >21 units (men) or >15 units (women) Vegans Intense aerobic exercise >20 min 3 x per week Participation in another clinical trial Antibiotics in previous 3 months before study Low haemoglobin levels Females who are pregnant, lactating, or if of reproductive age and not using a reliable form of contraception (including abstinence)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Spray dried blackcurrant powder dissolved in water | Other: Beverage: Spray dried blackcurrant powder dissolved in water<br> <br> |
| Placebo Comparator: Placebo<br>(sucrose, glucose, fructose, maltodextrin, malic acid, citric acid, vitamin C, artificial blackcurrant flavouring and low-nitrate water) | Other: Beverage: Placebo (sucrose, glucose, fructose, maltodextrin, malic acid, citric acid, vitamin C, artificial blackcurrant flavouring and low-nitrate water)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in vascular reactivity measured by flow-mediated dilatation (FMD) |  | Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention | 
| Change from baseline in platelet function measured by agonist-induced platelet aggregation |  | Acute study: measured at baseline and 2 and 4 h post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the concentration of polyphenols and their metabolites and degradants in blood and urine samples measured by HPLC-MS/MS |  | Acute study: plasma measured at baseline and 1, 2, 4, 6 and 24 h post intervention, urine measured at baseline and 1, 2, 4, 6 and 6-24 h post intervention | 
| Change from baseline in vascular function measured by digital volume pulse (DVP) |  | Acute study: measured at baseline and 2, 4 and 6 h post intervention | 
| Change from baseline in blood pressure |  | Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention | 
| Change from baseline in the concentration of nitric oxide in plasma measured by ozone-based chemiluminescence |  | Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention | 
| Change from baseline in the concentration of selected cytokines (TNF-a, IL-1b, IL-6, IL-8 and IL-10) in plasma measured using a cytometric bead array kit from BD Biosciences |  | Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention | 
| Change from baseline in platelet function (numbers of circulating micro particles by nano particle tracking analysis) |  | Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention (urine metabonomics additionally 6-24h) | 
| Metabonomics on urine and plasma samples measured by nuclear magnetic resonance spectroscopy |  | Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention (urine metabonomics additionally 6-24h) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anthocyanins, bioavailability