Measurement of Urinary Catabolites of PACs as Biomarkers of Consumption of Cranberry Extracts

Urinary Tract Infections Clinical Trial

— CUPACS  

Official title:

Measurement of Urinary Catabolites of the Proanthocyanidines (PACs) in Healthy Young Women as Biomarkers of Consumption of Cranberry Extracts.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02087735
• Other study ID #: PACS-2013-SD
• Status: Completed
• Phase: Phase 1
• First received: March 12, 2014
• Last updated: October 7, 2016
• Start date: January 2014
• Est. completion date: March 2014

Study information

• Verified date: October 2016
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this cross over pilot study is to investigate the urinary catabolites of Proanthocyanidines (PACs) as biomarkers of cranberry extracts in healthy young women.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy women.

• 18 to 40 years.

Exclusion Criteria:

• No internet access.

• No refrigerator access during the 9 hours of sample collection.

• Women who had or expect to take antibiotic.

• Women who had or expect to take cranberries, blueberries or bilberries in the form of berries, juice or extracts.

• Women who had or expect to take dark chocolate.

• Women who had personal history of acute or chronic renal failure.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Urinary Tract Infections

Intervention

Dietary Supplement:
• Cranberry extract
The aim of this pilot study is to evaluate the urinary catabolites of PACs as a biomarker of consumption of cranberry extracts within 9 hours of intercourse. Once a week, for 3 weeks, the women will receive a sequence of 3 different cranberry extracts (72 mg, 36 mg and 2mg (placebo)). The participant will have to collect its urine for a period of 9 hours in 3 different containers (one different container for 3 hours).

Locations

Country	Name	City	State
Canada	Laval University, Department of Medecine, Institut sur la nutrition et les aliments fonctionnels (INAF).	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary catabolites of PACs		within 9 hours following the intake of cranberry extracts	No