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Dose-dependent Effects of Blueberry Polyphenols on Endothelial Function in Healthy Individuals (BB2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01829542
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : April 11, 2013
Sponsor:
Collaborator:
Alpro Foundation
Information provided by (Responsible Party):
Jeremy Paul Edward Spencer, University of Reading

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.

Condition or disease Intervention/treatment Phase
Endothelial Function Dietary Supplement: Freeze-dried blueberry powder dissolved in water Dietary Supplement: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Dose-dependent Effects of Blueberry Polyphenols on Endothelial Function in Healthy Individuals
Study Start Date : May 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 319 mg blueberry polyphenols
Freeze-dried blueberry powder dissolved in water
Dietary Supplement: Freeze-dried blueberry powder dissolved in water
Wild blueberry freeze-dried powder dissolved in water

Active Comparator: 639 mg blueberry polyphenols
Freeze-dried blueberry powder dissolved in water
Dietary Supplement: Freeze-dried blueberry powder dissolved in water
Wild blueberry freeze-dried powder dissolved in water

Active Comparator: 766 mg blueberry polyphenols
Freeze-dried blueberry powder dissolved in water
Dietary Supplement: Freeze-dried blueberry powder dissolved in water
Wild blueberry freeze-dried powder dissolved in water

Active Comparator: 1466 mg blueberry polyphenols
Freeze-dried blueberry powder dissolved in water
Dietary Supplement: Freeze-dried blueberry powder dissolved in water
Wild blueberry freeze-dried powder dissolved in water

Active Comparator: 1791 mg total blueberry polyphenols
Freeze-dried blueberry powder dissolved in water
Dietary Supplement: Freeze-dried blueberry powder dissolved in water
Wild blueberry freeze-dried powder dissolved in water

Placebo Comparator: O mg blueberry polyphenols
Macro- and micronutrient matched control drink
Dietary Supplement: Control
Macro- and micro-nutrient matched control in water




Primary Outcome Measures :
  1. Flow-mediated dilation [ Time Frame: 0-1 hour after consumption ]

Secondary Outcome Measures :
  1. plasma blueberry polyphenol metabolites [ Time Frame: 0-1 h after consumption ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829542


Locations
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United Kingdom
Hugh Sinclair Unit of Human Nutrition
Reading, Berkshire, United Kingdom, RG6 6AP
Sponsors and Collaborators
University of Reading
Alpro Foundation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jeremy Paul Edward Spencer, Professor, University of Reading
ClinicalTrials.gov Identifier: NCT01829542    
Other Study ID Numbers: BB2UReading
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: April 2013
Keywords provided by Jeremy Paul Edward Spencer, University of Reading:
flow-mediated dilation
blueberry polyphenols
dose-dependency