Cranberry Extract and Urinary Infection Prevention: a Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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Cranberry juice, fruit (fresh and dried), functional foods, and cranberry dietary supplements are promoted for prevention of urinary tract infections (UTIs) on the basis of their content of cranberry proanthocyanidins (PACs) with "A-type" interflavan bonds. Several clinical trials have assessed efficacy of cranberry-derived products, essentially with cranberry juices, but discordant results have been found. Lack of compliance but mostly lack of standardization in product concentrations can account for the variability among results. Indeed, most clinical trials do not report quantity of PACs. According to most recent studies, quantification of PACs requiring standardized and reproducible methods should be at least 37 mg/day. It can be hypothesized that efficacy of cranberry extract in UTIs prevention among young women can be strongly increased using optimal dosage (standardized to 37 mg/day of PACs). The purpose of this clinical trial study is to assess, among young and sexually active women presenting recurrent UTIs, efficacy of an optimal dose of cranberry extract quantified and standardized to 37 mg/day of 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

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Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Cranberry extract

Intervention Type DIETARY_SUPPLEMENT

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.

Control dose

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

Group Type PLACEBO_COMPARATOR

Cranberry extract

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes