NCT01292954

Brief Summary

Scientific question to be addressed: To determine the effects of acute blueberry ingestion on vascular function and blood pressure in humans Hypothesis: Acute consumption of blueberry induces an improvement in blood pressure and vascular function through the impact of blueberry flavonoids on the vascular system. Study objectives: To determine the dose-dependency of a blueberry drink on blood pressure and vascular function in healthy subjects and to determine pharmacokinetics of blueberry polyphenols

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Oct 2010

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2011

Completed
Last Updated

February 10, 2011

Status Verified

February 1, 2011

Enrollment Period

3 months

First QC Date

February 9, 2011

Last Update Submit

February 9, 2011

Conditions

Healthy

Keywords

blueberriesvascular functionFMDBlood pressureLaser Dopplerpharmacokineticsabsorptionmetabolismpolyphenolsflavonoids

Outcome Measures

Primary Outcomes (1)

  • Flow-mediated dilation

    0-6 hours after consumption

Secondary Outcomes (3)

  • Blueberry polyphenols pharmacokinetics

    0- 24 h after consumption

  • Blood Pressure

    0-6 hours after consumption

  • Laser Doppler Iontophoresis

    0-6 hours after consumption

Study Arms (4)

Low dose blueberry

ACTIVE COMPARATOR
Dietary Supplement: Blueberries

medium dose blueberry

ACTIVE COMPARATOR
Dietary Supplement: Blueberries

high dose blueberry

ACTIVE COMPARATOR
Dietary Supplement: Blueberries

control

PLACEBO COMPARATOR
Dietary Supplement: Blueberries

Interventions

BlueberriesDIETARY_SUPPLEMENT

low dose: 31.4 g of freeze dried blueberry reconstituted in water medium dose: 57 g of freeze dried blueberry reconstituted in water high dose: 80 g of freeze dried blueberry reconstituted in water Placebo: sugars and vitamin c match control in water Frequency:1 single time Total Duration: 3 days study over 3 weeks period

Low dose blueberrycontrolhigh dose blueberrymedium dose blueberry

Eligibility Criteria

Age19 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • A signed consent form
  • Age 19-40 years old
  • Body mass index - 18.5-30 kg/m2

You may not qualify if:

  • Blood pressure \> 150/90 mmHg
  • Haemoglobin (anaemia marker) \< 125 g/l
  • Gamma GT (liver enzymes) \> 80 IU/l
  • Cholesterol \> 6.5 mmol/l
  • Had suffered a myocardial infarction or stroke in the previous 12 months
  • Suffers from any reproductive disorder
  • 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
  • Drinking more than 21 units per week
  • On any medication affecting blood clotting
  • On any vitamin supplements/fish oil capsules
  • Smoking
  • Vegetarians or vegans

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

Location

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

blueberry extract

Study Officials

  • Jeremy Spencer, PhD

    University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2011

First Posted

February 10, 2011

Study Start

October 1, 2010

Primary Completion

January 1, 2011

Study Completion

February 1, 2011

Last Updated

February 10, 2011

Record last verified: 2011-02

Locations

GB(1)