A Randomized, Parallel, Controlled Trial Investigating the Effects a Cranberry-Based Products on the Female Microbiome
Ocean Spray Cranberries, Inc.
Summary
The overall objective of this clinical trial is to compare the effects of a cranberry-based product to a placebo-control product on vaginal and GI microbiome outcomes and associated participant reported outcomes in generally healthy pre-menopausal women
Description
Among various strategies explored to modulate the composition and function of different microbiomes, dietary interventions, like the consumption of cranberry-based products have garnered interest due to their historical use and emerging scientific evidence suggesting beneficial effects on host health. Cranberries are rich in bioactive compounds, notably polyphenols such as proanthocyanidins, which have been investigated for their potential to influence microbial adhesion and growth, especially in the genitourinary tract. While cranberry phenolic compounds generally exhibit poor bioavailability…
Eligibility
- Age range
- 18–45 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * Pre-menopausal female, * 18 - 45 years of age (inclusive) at visit 1. * History of regular menstrual cycles (21-35 d per cycle or at the investigator's discretion) for at least 3 months prior to visit 1. Participants that are using contraceptives (IUD, patch, or pills) must be on a stable dose, defined as no change in medication regimen, within 90 days of visit 1 (or within 6 months of visit 1 for copper IUD users) and no plans to change hormonal contraceptive use during the study. * BMI ≥18.5 to \<30.0 kg/m2 at visit 1. * Willing to adhere to all study procedures, inclu…
Interventions
- Dietary SupplementActive
Cranberry Beverage
- Dietary SupplementPlacebo
Placebo Beverage
Location
- BiofortisChicago, Illinois