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

NCT02087735 | Completed Phase 1 DMC

• 1 other identifier: PACS-2013-SD
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infections

Keywords

Cranberry; Proanthocyanidins; Urinary catabolites

Outcome Measures

Primary Outcomes (1)

• Urinary catabolites of PACs

  within 9 hours following the intake of cranberry extracts

Study Arms (3)

cranberry extract 1

EXPERIMENTAL

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

Dietary Supplement: Cranberry extract

cranberry extract 2.

EXPERIMENTAL

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

Dietary Supplement: Cranberry extract

cranberry extract 3.

PLACEBO COMPARATOR

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

Dietary Supplement: Cranberry extract

Interventions

Cranberry extract DIETARY_SUPPLEMENT

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).

cranberry extract 1; cranberry extract 2.; cranberry extract 3.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy women.
• to 40 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

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

Québec, Quebec, G1V 0A6, Canada

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Sylvie Dodin, MD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sylvie Dodin, MD

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 14, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: October 10, 2016

Record last verified: 2016-10

Locations

CA (1)