Anthocyanin-rich Blackcurrant and Vascular Function

Inflammation Clinical Trial

Official title:

Effects of an Anthocyanin-rich Blackcurrant Beverage on Cardiovascular Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02459756
• Other study ID #: UREC 14/17
• Status: Completed
• Phase: N/A
• First received: May 20, 2015
• Last updated: February 8, 2016
• Start date: June 2015
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 55 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Inflammation
• Vascular Stiffness

Intervention

Other:
• Beverage: Spray dried blackcurrant powder dissolved in water

• Beverage: Placebo (sucrose, glucose, fructose, maltodextrin, malic acid, citric acid, vitamin C, artificial blackcurrant flavouring and low-nitrate water)

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading

Sponsors (2)

Lead Sponsor	Collaborator
University of Reading	GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Change from baseline in platelet function measured by agonist-induced platelet aggregation		Acute study: measured at baseline and 2 and 4 h post intervention	No
Secondary	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	No
Secondary	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	No
Secondary	Change from baseline in blood pressure		Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention	No
Secondary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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)	No