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The Effects of Cranberry Juice on Bacterial Adhesion

This study has been completed.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00318253
First received: April 24, 2006
Last updated: July 8, 2009
Last verified: July 2009
  Purpose

The study is based on the hypothesis that consumption of cranberry juice products results in the production of metabolites in the urine that have anti-adhesive properties on bacteria. A crossover study using 12 healthy women will be given different cranberry products or water as a control and their urine will be analyzed for anti-adhesive effects and compared to the properties of the urine. Cranberry juice will also be evaluated for its effect on vaginal microflora.


Condition Intervention
Bacterial Vaginosis
Oxaluria
Procedure: cranberry juice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: The Effects of Cranberry Juice on Urine and Bacterial Adhesion to Cells

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • bacterial adhesion to tissue cells
  • microbial population shifts in vaginal tract [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: March 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Hypothesis: Metabolites in cranberry juice, have anti-adhesive properties for uropathogenic bacteria but they do not disturb the normal vaginal flora.

Study design and assays:

A crossover study design using 12 healthy women will be conducted for 50 days. The anti-adhesive properties of the urine will be determined using uropathogens and changes in the vaginal microflora will be evaluated.

Participants:

The subjects will be healthy premenopausal women aged 19-45, who have no history of chronic urinary tract infection or have had a urinary tract infection in the past 12 months, and are currently not taking antibiotics or any supplements to prevent UTI, including cranberry juice. The subjects must not have urinary tract abnormalities, requiring catheterization for micturition, be pregnant, or diabetic or have allergies to berry juices. Each test phase is 1 week (7 days) and the following protocol will be followed:

Subjects 1-3 Test phase I: water; washout phase Test phase II: cranberries; washout phase Test phase III: cranberry juice- 1/day; washout phase Test phase IV: cranberry juice- 2/day

4-6 Test phase I: cranberry juice- 2/day; washout phase Test phase II: water; washout phase Test phase III: cranberries; washout phase Test phase IV: cranberry juice- 1/day

7-9 Test phase I: cranberry juice- 1/day; washout phase Test phase II: cranberry juice- 2/day; washout phase Test phase III: water; washout phase Test phase IV: cranberries

10-12 Test phase I: cranberries; washout phase Test phase II: cranberry juice- 1/day; washout phase Test phase III: cranberry juice- 2/day; washout phase Test phase IV: water

During the washout period, the subjects will return to their normal diet with no added beverage or food, although again no cranberry juice can be consumed. The beverages/food to be taken for the 7 day phases comprise:

  1. Water - Control group
  2. Cranberry juice 1/day
  3. Cranberry juice 2/day
  4. Cranberries (dried)

Regime and sampling:

A mid stream urine sample will be collected to evaluate the anti-adhesive effects of the various treatments.

Mid stream urine will also be collected to evaluate anti-adhesive properties of the urine, and determine if changes occur following washout.

A 24 h urine will be collected after 3-4 days of each phase for urinalysis.

Vaginal swabs will be collected to determine the effect, if any, of the foods on the composition of the vaginal microflora.

  Eligibility

Ages Eligible for Study:   19 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 19-45 years
  • Healthy pre-menopausal female volunteers with no history of urinary tract infections over the past 12 months.

Exclusion Criteria:

  • Experienced a urinary tract infection in the past 12 months
  • Receiving antibiotic therapy or supplements to prevent urinary tract infections
  • Pregnant, postmenopausal or outside of the age range (19-45 years old)
  • Anatomical abnormality of the urinary tract, such as following surgery
  • Using a catheter to manage micturition
  • Diabetic
  • Allergic to berry juices
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318253

Sponsors and Collaborators
Lawson Health Research Institute
Otsuka Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Gregor Reid, PhD, MBA The Lawson Health Research Institute and The University of Western Ontario
  More Information

No publications provided

Responsible Party: Dr. G. Reid, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00318253     History of Changes
Other Study ID Numbers: R-06-704, SP 0732
Study First Received: April 24, 2006
Last Updated: July 8, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Cranberry juice
Antiadhesion
Urinary tract infection
vaginosis

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Genital Diseases, Female
Vaginal Diseases
Vaginitis

ClinicalTrials.gov processed this record on November 20, 2014