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Clinical Trials/NCT02459756
NCT02459756CompletedNot Applicable

Effects of an Anthocyanin-rich Blackcurrant Beverage on Cardiovascular Function

University of Reading2 sites in 1 country23 target enrollmentStarted: June 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
23
Locations
2
Primary Endpoint
Change from baseline in platelet function measured by agonist-induced platelet aggregation
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
30 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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
  • •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)
  • •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)

Outcomes

Primary Outcomes

Change from baseline in platelet function measured by agonist-induced platelet aggregation

Time Frame: Acute study: measured at baseline and 2 and 4 h post intervention

Change from baseline in vascular reactivity measured by flow-mediated dilatation (FMD)

Time Frame: Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention

Secondary Outcomes

  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Professor Parveen Yaqoob, MA, DPhil, RNutr, FAfN

Professor Parveen Yaqoob

University of Reading

Study Sites (2)

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