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

NCT ID: NCT01829542

Last Updated: 2013-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Endothelial Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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319 mg blueberry polyphenols

Freeze-dried blueberry powder dissolved in water

Group Type ACTIVE_COMPARATOR

Freeze-dried blueberry powder dissolved in water

Intervention Type DIETARY_SUPPLEMENT

Wild blueberry freeze-dried powder dissolved in water

639 mg blueberry polyphenols

Freeze-dried blueberry powder dissolved in water

Group Type ACTIVE_COMPARATOR

Freeze-dried blueberry powder dissolved in water

Intervention Type DIETARY_SUPPLEMENT

Wild blueberry freeze-dried powder dissolved in water

766 mg blueberry polyphenols

Freeze-dried blueberry powder dissolved in water

Group Type ACTIVE_COMPARATOR

Freeze-dried blueberry powder dissolved in water

Intervention Type DIETARY_SUPPLEMENT

Wild blueberry freeze-dried powder dissolved in water

1466 mg blueberry polyphenols

Freeze-dried blueberry powder dissolved in water

Group Type ACTIVE_COMPARATOR

Freeze-dried blueberry powder dissolved in water

Intervention Type DIETARY_SUPPLEMENT

Wild blueberry freeze-dried powder dissolved in water

1791 mg total blueberry polyphenols

Freeze-dried blueberry powder dissolved in water

Group Type ACTIVE_COMPARATOR

Freeze-dried blueberry powder dissolved in water

Intervention Type DIETARY_SUPPLEMENT

Wild blueberry freeze-dried powder dissolved in water

O mg blueberry polyphenols

Macro- and micronutrient matched control drink

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

Macro- and micro-nutrient matched control in water

Interventions

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Freeze-dried blueberry powder dissolved in water

Wild blueberry freeze-dried powder dissolved in water

Intervention Type DIETARY_SUPPLEMENT

Control

Macro- and micro-nutrient matched control in water

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Alpro Foundation

OTHER

Sponsor Role collaborator

University of Reading

OTHER

Sponsor Role lead

Responsible Party

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Jeremy Paul Edward Spencer

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hugh Sinclair Unit of Human Nutrition

Reading, Berkshire, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 24004888 (View on PubMed)

Other Identifiers

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BB2UReading

Identifier Type: -

Identifier Source: org_study_id

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