Recruiting
Phase 1

Cranberry Extract

Sponsor:

Laval University

Code:

NCT02572895

Conditions

Urinary Tract Infections

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Cranberry extract

Study Details

Brief summary:

The purpose of this clinical trial study is to assess, among young and sexually active women presenting recurrent urinary tract infection (UTIs), efficacy of an optimal dose of cranberry extract quantified and standardized to 37 mg/day of Proanthocyanidins (PACs), compared to a control dose quantified and standardized to 2 mg/day of PACs on mean number of new UTIs during a 6-month follow-up period.

Conditions

Urinary Tract Infections

Study ID

NCT02572895

Start date

Aug, 2015

Status verified date

Sep, 2016

Completion date

Dec, 2017

Anticipated

Primary completion date

Jun, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy and sexually active women
  • Aged between 18 to 45 years old
  • Recurrence of 2 UTIs in the past 6 months or 3 in the past year
  • Do not have consumed cranberry juice, polyphenols or antioxidant supplements in the last 2 weeks
  • Internet access

Exclusion Criteria:

  • Women who have personal history of acute or chronic renal failure
  • Women who have personal history of urogenital system anomalies, urogenital tractus surgery or intestinal diseases causing malabsorption (e.g., Crohn and celiac diseases)
  • Women who have personal history of kidney stones, taking anticoagulant medication or have taken anticoagulant medication in the last month
  • Women presenting cranberry allergy or intolerance

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Optimal dose

One capsule with a proanthocyanidins standardized cranberry extract of 18,5 mg twice a day, i.e. in the morning and at night.

placebo comparator: Control dose

One capsule with a proanthocyanidins standardized cranberry extract of 1 mg twice a day, i.e. in the morning and at night.

Interventions

Cranberry extract

The aim of this clinical trial is to assess efficacy of an optimal dose of cranberry extract compared to a control dose on mean number of new UTIs for a 6-month period follow-up in women. Participants will be randomly assigned to the optimal dose or control dose treatment at their first visit at the Institute of Nutrition and Functional Foods. This intervention includes three visits at 0, 12 and 24 weeks. At the first visit, women will have to complete questionnaires to provide sociodemographic, medication and natural health products, health antecedents and quality of life information and to document risk factors related to UTIs. A 24-hour recall questionnaire about consumption of PACs will also be completed. A urinary sample analysis and culture as well as a pregnant test will also be performed. Compliance regarding capsules' intake and potential side effects will be documented. The completion of questionnaires and urinary measurements will be repeated at weeks 12 and 24.

Primary outcome measure

  • Mean number of urinary tract infections [ Time Frame: Within a 6-month period ]

Central Contacts and Locations

Central contacts

Vicky Leblanc, Dt.P., Ph.D.

418-656-2131vicky.leblanc.1@ulaval.ca

Sylvie Dodin, M.Sc., MD.

418-525-4307sylvie.dodin@ogy.ulaval.ca

Locations

Laval University

Recruiting

Québec, Quebec, Canada, G1V 0A6

Contacts

Vicky Leblanc, Dt.P., Ph.D.

418-656-2131vicky.leblanc.1@ulaval.ca

Sylvie Dodin, M.Sc., MD.

418-525-4307sylvie.dodin@ogy.ulaval.ca

More Information

Sponsor

Laval University

Last update posted

Sep 9, 2016

Last verified

Sep, 2016

Keywords

  • Cranberry
  • Proanthocyanidins
  • Urinary catabolites

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2016-09-09.