Dose-dependent Effects of Blueberry Polyphenols on Endothelial Function in Healthy Individuals
BB2
1 other identifier
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 8, 2013
CompletedFirst Posted
Study publicly available on registry
April 11, 2013
CompletedApril 11, 2013
April 1, 2013
3 months
April 8, 2013
April 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Flow-mediated dilation
0-1 hour after consumption
Secondary Outcomes (1)
plasma blueberry polyphenol metabolites
0-1 h after consumption
Study Arms (6)
319 mg blueberry polyphenols
ACTIVE COMPARATORFreeze-dried blueberry powder dissolved in water
639 mg blueberry polyphenols
ACTIVE COMPARATORFreeze-dried blueberry powder dissolved in water
766 mg blueberry polyphenols
ACTIVE COMPARATORFreeze-dried blueberry powder dissolved in water
1466 mg blueberry polyphenols
ACTIVE COMPARATORFreeze-dried blueberry powder dissolved in water
1791 mg total blueberry polyphenols
ACTIVE COMPARATORFreeze-dried blueberry powder dissolved in water
O mg blueberry polyphenols
PLACEBO COMPARATORMacro- and micronutrient matched control drink
Interventions
Wild blueberry freeze-dried powder dissolved in water
Macro- and micro-nutrient matched control in water
Eligibility Criteria
You may qualify if:
- Male
- years
- Healthy
- signed consent form
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Readinglead
- Alpro Foundationcollaborator
Study Sites (1)
Hugh Sinclair Unit of Human Nutrition
Reading, Berkshire, RG6 6AP, United Kingdom
Related Publications (1)
Rodriguez-Mateos A, Rendeiro C, Bergillos-Meca T, Tabatabaee S, George TW, Heiss C, Spencer JP. Intake and time dependence of blueberry flavonoid-induced improvements in vascular function: a randomized, controlled, double-blind, crossover intervention study with mechanistic insights into biological activity. Am J Clin Nutr. 2013 Nov;98(5):1179-91. doi: 10.3945/ajcn.113.066639. Epub 2013 Sep 4.
PMID: 24004888DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 8, 2013
First Posted
April 11, 2013
Study Start
May 1, 2012
Primary Completion
August 1, 2012
Study Completion
October 1, 2012
Last Updated
April 11, 2013
Record last verified: 2013-04