Urinary Excretion of Anthocyanins During Long Term Blueberry Feeding

February 8, 2013 updated by: Atlantic Food and Horticulture Research Center
Essentially all of the published data on anthocyanin absorption in humans are from short term studies - a few days or less, most typically 24 h. However human studies demonstrating clinical effects are typically conducted for several weeks or even months. To examine how anthocyanin absorption and metabolism may be affected this study will examine urinary excretion of anthocyanins over one month, followed by a one week washout, and then one more dose of blueberry juice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Kentville, Nova Scotia, Canada, B4N 1J5
        • Atlantic Food & Horticulture Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provided written consent (see: Information and Consent Form)
  • Fluent in English
  • Complete a confidential medical questionnaire (Appendix 6)
  • Able and willing to abide by the dietary restrictions as described
  • Able and willing to abide by the urine collection protocols as described

Exclusion Criteria:

  • No written consent
  • No confidential medical questionnaire
  • Unable to comply with diet restrictions and other study requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: anthocyanin-free diet
Maintain anthocyanin-free diet throughout study. Day 1 to day 30, consume daily 250 ml single strength blueberry juice containing 229 mg anthocyanins, taken either as 1 morning dose or 1/3 dose morning, 1/3 mid-day and 1/3 evening. At d 31-38 continue anthocyanin-free diet. On d 39 consume daily dose.
Other: Blueberry Juice
Dietary intervention
Other Names:
  • Single strength wild blueberry juice, commercially prepared.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anthocyanins and Phase 2 anthocyanin conjugates in urine
Time Frame: 5 weeks
5 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
White blood cell gene expression at start and end of study
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atlantic Food and Horticulture Research Center

Investigators

  • Principal Investigator: Wilhelmina - Kalt, Ph.D., Research Scientist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 8, 2013

First Submitted That Met QC Criteria

February 8, 2013

First Posted (Estimate)

February 12, 2013

Study Record Updates

Last Update Posted (Estimate)

February 12, 2013

Last Update Submitted That Met QC Criteria

February 8, 2013

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BBAnthoUrine
  • AAFC-WBANA (Other Grant/Funding Number: Agriculture & Agri-Food Canada)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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