The Effects of Cranberry Juice on Bacterial Adhesion
|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|
- bacterial adhesion to tissue cells
- microbial population shifts in vaginal tract [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Study Completion Date:||August 2006|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
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.
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:
- Water - Control group
- Cranberry juice 1/day
- Cranberry juice 2/day
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318253
|Principal Investigator:||Gregor Reid, PhD, MBA||The Lawson Health Research Institute and The University of Western Ontario|