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

Primary Purpose

Urinary Tract Infections

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Cranberry extract
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Urinary Tract Infections focused on measuring Cranberry, Proanthocyanidins, Urinary catabolites

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Laval University, Department of Medecine, Institut sur la nutrition et les aliments fonctionnels (INAF).

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

cranberry extract 1

cranberry extract 2.

cranberry extract 3.

Arm Description

One capsule with a proanthocyanidin standardized cranberry extract of 36 mg and one capsule of placebo cranberry extract.

Two capsules with a proanthocyanidin standardized cranberry extract of 36 mg.

Two capsules with a proanthocyanidin standardized cranberry extract of 2 mg.

Outcomes

Primary Outcome Measures

Urinary catabolites of PACs

Secondary Outcome Measures

Full Information

First Posted
March 12, 2014
Last Updated
October 7, 2016
Sponsor
Laval University
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1. Study Identification

Unique Protocol Identification Number
NCT02087735
Brief Title
Measurement of Urinary Catabolites of PACs as Biomarkers of Consumption of Cranberry Extracts
Acronym
CUPACS
Official Title
Measurement of Urinary Catabolites of the Proanthocyanidines (PACs) in Healthy Young Women as Biomarkers of Consumption of Cranberry Extracts.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
Keywords
Cranberry, Proanthocyanidins, Urinary catabolites

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cranberry extract 1
Arm Type
Experimental
Arm Description
One capsule with a proanthocyanidin standardized cranberry extract of 36 mg and one capsule of placebo cranberry extract.
Arm Title
cranberry extract 2.
Arm Type
Experimental
Arm Description
Two capsules with a proanthocyanidin standardized cranberry extract of 36 mg.
Arm Title
cranberry extract 3.
Arm Type
Placebo Comparator
Arm Description
Two capsules with a proanthocyanidin standardized cranberry extract of 2 mg.
Intervention Type
Dietary Supplement
Intervention Name(s)
Cranberry extract
Intervention Description
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).
Primary Outcome Measure Information:
Title
Urinary catabolites of PACs
Time Frame
within 9 hours following the intake of cranberry extracts

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie Dodin, MD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laval University, Department of Medecine, Institut sur la nutrition et les aliments fonctionnels (INAF).
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada

12. IPD Sharing Statement

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

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