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

Study Overview
=================
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.

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

Conditions
-----------------
Urinary Tract Infections

Intervention / Treatment
-----------------
* Dietary Supplement: Cranberry extract


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cranberry extract 1<br>One capsule with a proanthocyanidin standardized cranberry extract of 36 mg and one capsule of placebo cranberry extract. | Dietary Supplement: Cranberry extract<br>* 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).<br>|
| Experimental: cranberry extract 2.<br>Two capsules with a proanthocyanidin standardized cranberry extract of 36 mg. | Dietary Supplement: Cranberry extract<br>* 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).<br>|
| Placebo Comparator: cranberry extract 3.<br>Two capsules with a proanthocyanidin standardized cranberry extract of 2 mg. | Dietary Supplement: Cranberry extract<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cranberry, Proanthocyanidins, Urinary catabolites