Measurement of Urinary Catabolites of PACs as Biomarkers of Consumption of Cranberry Extracts (CUPACS)

October 7, 2016 updated by: Sylvie Dodin, Laval University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

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
    • Quebec
      • Québec, Quebec, Canada, G1V 0A6
        • Laval University, Department of Medecine, Institut sur la nutrition et les aliments fonctionnels (INAF).

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

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 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: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: cranberry extract 1
One capsule with a proanthocyanidin standardized cranberry extract of 36 mg and one capsule of placebo cranberry extract.
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).
EXPERIMENTAL: cranberry extract 2.
Two capsules with a proanthocyanidin standardized cranberry extract of 36 mg.
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).
PLACEBO_COMPARATOR: cranberry extract 3.
Two capsules with a proanthocyanidin standardized cranberry extract of 2 mg.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Urinary catabolites of PACs
Time Frame: within 9 hours following the intake of cranberry extracts
within 9 hours following the intake of cranberry extracts

Collaborators and Investigators

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

Sponsor

Laval University

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

January 1, 2014

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

March 12, 2014

First Submitted That Met QC Criteria

March 13, 2014

First Posted (ESTIMATE)

March 14, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 10, 2016

Last Update Submitted That Met QC Criteria

October 7, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PACS-2013-SD

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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