Urinary Excretion of Anthocyanins During Long Term Blueberry Feeding

Bioavailability Clinical Trial

Official title:

Urinary Excretion of Anthocyanins During Long Term Blueberry Feeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789359
• Other study ID #: BBAnthoUrine
• Secondary ID: AAFC-WBANA
• Status: Completed
• Phase: N/A
• First received: February 8, 2013
• Last updated: February 8, 2013
• Start date: November 2012
• Est. completion date: December 2012

Study information

• Verified date: October 2012
• Source: Atlantic Food and Horticulture Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bioavailability

Intervention

Other:
• Blueberry Juice
Dietary intervention

Locations

Country	Name	City	State
Canada	Atlantic Food & Horticulture Research Centre	Kentville	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Atlantic Food and Horticulture Research Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anthocyanins and Phase 2 anthocyanin conjugates in urine		5 weeks	No
Secondary	White blood cell gene expression at start and end of study		4 weeks	No