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Clinical Trials/NCT02459756
NCT02459756
Completed
Not Applicable

Effects of an Anthocyanin-rich Blackcurrant Beverage on Cardiovascular Function

University of Reading1 site in 1 country23 target enrollmentJune 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vascular Stiffness
Sponsor
University of Reading
Enrollment
23
Locations
1
Primary Endpoint
Change from baseline in platelet function measured by agonist-induced platelet aggregation
Status
Completed
Last Updated
10 years ago

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.

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
November 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Professor Parveen Yaqoob, MA, DPhil, RNutr, FAfN

Professor Parveen Yaqoob

University of Reading

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
  • 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

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))

Study Sites (1)

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