Dose-dependent Effects of Blueberry Polyphenols on Endothelial Function in Healthy Individuals

Endothelial Function Clinical Trial

— BB2  

Official title:

Dose-dependent Effects of Blueberry Polyphenols on Endothelial Function in Healthy Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01829542
• Other study ID #: BB2UReading
• Status: Completed
• Phase: N/A
• First received: April 8, 2013
• Last updated: April 10, 2013
• Start date: May 2012
• Est. completion date: October 2012

Study information

• Verified date: April 2013
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the impact of acute blueberry polyphenol intake on endothelial function of healthy volunteers. Specifically, the investigators plan to perform a randomised, double blind, cross-over human intervention trial using a blueberry drink to investigate the dose-dependent effects of blueberry polyphenols on blood vessel function using Flow mediated dilation (FMD) to measure endothelial function. The study will not only measure the acute effects of flavonoid ingestion on vascular reactivity but will also assess plasma polyphenol metabolite levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Male

• 18-40 years

• Healthy

• signed consent form

Exclusion Criteria:

• Blood pressure > 140/90 mmHg

• Had suffered a myocardial infarction or stroke

• Suffers from any blood-clotting disorder

• Suffers from any metabolic disorders (e.g. diabetes or any other endocrine or liver diseases)

• Any dietary restrictions or on a weight reducing diet

• Allergies or intolerances to any foods

• Smoker

• Heavy drinker (>21 units per week)

• On any lipid-modifying medication

• On any blood pressure lowering medication

• On any medication affecting blood clotting

• Taking high dose fish oil supplements (greater then 1 g EPA and DHA per day) or high doses of antioxidant vitamins (greater then 800 µg vitamin A, 60 mg vitamin C, 10 mg vitamin E or 400 µg beta carotene)

• Taking probiotics, prebiotics, synbiotics, antibiotics or anti-inflammatory or blood lowering medication within a 2-month period prior to the study

• Planning on altering consumption of vitamin supplements/fish oil capsules during the course of the study

• Undertakes strenuous exercise > 4 times per week for > 1 hour per session

• Haemoglobin levels below reference range provided by the Royal Berkshire Hospital

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Endothelial Function

Intervention

Dietary Supplement:
• Freeze-dried blueberry powder dissolved in water
Wild blueberry freeze-dried powder dissolved in water
• Control
Macro- and micro-nutrient matched control in water

Locations

Country	Name	City	State
United Kingdom	Hugh Sinclair Unit of Human Nutrition	Reading	Berkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Reading	Alpro Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow-mediated dilation		0-1 hour after consumption	No
Secondary	plasma blueberry polyphenol metabolites		0-1 h after consumption	No