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Completed

NCT Number: NCT02459756

Anthocyanin-rich Blackcurrant and Vascular Function

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.

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Key information

Conditions

Vascular Stiffness Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading

Reading, RG6 6AP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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)

Other

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Change from baseline in the concentration of polyphenols and their metabolites and degradants in blood and urine samples measured by HPLC-MS/MS

    Time frame: 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

  2. Change from baseline in vascular function measured by digital volume pulse (DVP)

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

  3. Change from baseline in blood pressure

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

  4. Change from baseline in the concentration of nitric oxide in plasma measured by ozone-based chemiluminescence

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

  5. 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

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

  6. Change from baseline in platelet function (numbers of circulating micro particles by nano particle tracking analysis)

    Time frame: Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention (urine metabonomics additionally 6-24h)

  7. Metabonomics on urine and plasma samples measured by nuclear magnetic resonance spectroscopy

    Time frame: Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention (urine metabonomics additionally 6-24h)

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Effects of an Anthocyanin-rich Blackcurrant Beverage on Cardiovascular Function

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 2, 2015
Registry last updated
Feb 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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