Clinical trial NCT02459756: Anthocyanin-rich Blackcurrant and Vascular Function
Official title: Effects of an Anthocyanin-rich Blackcurrant Beverage on Cardiovascular Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Stiffness
Inflammation
Keywords: anthocyanins
bioavailability
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2015-06-02
Enrollment: 23
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change from baseline in vascular reactivity measured by flow-mediated dilatation (FMD)
timeFrame: Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention
measure: Change from baseline in platelet function measured by agonist-induced platelet aggregation
timeFrame: Acute study: measured at baseline and 2 and 4 h post intervention
Secondary outcomes:
measure: Change from baseline in the concentration of polyphenols and their metabolites and degradants in blood and urine samples measured by HPLC-MS/MS
timeFrame: 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
measure: Change from baseline in vascular function measured by digital volume pulse (DVP)
timeFrame: Acute study: measured at baseline and 2, 4 and 6 h post intervention
measure: Change from baseline in blood pressure
timeFrame: Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention
measure: Change from baseline in the concentration of nitric oxide in plasma measured by ozone-based chemiluminescence
timeFrame: Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention
measure: 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
timeFrame: Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention
measure: Change from baseline in platelet function (numbers of circulating micro particles by nano particle tracking analysis)
timeFrame: Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention (urine metabonomics additionally 6-24h)
measure: Metabonomics on urine and plasma samples measured by nuclear magnetic resonance spectroscopy
timeFrame: Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention (urine metabonomics additionally 6-24h)
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
Study officials:
affiliation: University of Reading
name: Parveen Yaqoob, DPhil
role: PRINCIPAL_INVESTIGATOR
References: