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Clinical Trials/NCT01829542
NCT01829542CompletedNot Applicable

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

University of Reading1 site in 1 country11 target enrollmentStarted: May 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
11
Locations
1
Primary Endpoint
Flow-mediated dilation

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •18-40 years
  • •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
  • •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

Arms & Interventions

319 mg blueberry polyphenols

Active Comparator

Freeze-dried blueberry powder dissolved in water

Intervention: Freeze-dried blueberry powder dissolved in water (Dietary Supplement)

639 mg blueberry polyphenols

Active Comparator

Freeze-dried blueberry powder dissolved in water

Intervention: Freeze-dried blueberry powder dissolved in water (Dietary Supplement)

766 mg blueberry polyphenols

Active Comparator

Freeze-dried blueberry powder dissolved in water

Intervention: Freeze-dried blueberry powder dissolved in water (Dietary Supplement)

1466 mg blueberry polyphenols

Active Comparator

Freeze-dried blueberry powder dissolved in water

Intervention: Freeze-dried blueberry powder dissolved in water (Dietary Supplement)

1791 mg total blueberry polyphenols

Active Comparator

Freeze-dried blueberry powder dissolved in water

Intervention: Freeze-dried blueberry powder dissolved in water (Dietary Supplement)

O mg blueberry polyphenols

Placebo Comparator

Macro- and micronutrient matched control drink

Intervention: Control (Dietary Supplement)

Outcomes

Primary Outcomes

Flow-mediated dilation

Time Frame: 0-1 hour after consumption

Secondary Outcomes

  • plasma blueberry polyphenol metabolites(0-1 h after consumption)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jeremy Paul Edward Spencer

Professor

University of Reading

Study Sites (1)

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