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
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, they have been shown to be metabolized by gut microbiota through fermentation in the distal intestine, yielding bioavailable and bioactive bacteria-derived metabolites. These findings highlight the critical need to understand the potential crosstalk between human microbiome ecosystems and how dietary cranberries might modulate this interaction to impact health outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Biofortis
Chicago, Illinois, United States
RECRUITINGVaginal Microbiome
The number of participants exhibiting a Lactobacillus-dominant CST vaginal microbiome following the 28-day intervention
Time frame: 4 weeks
Vaginal Microbiome Diversity
Microbiome diversity (e.g., α-diversity, β-diversity, Bray-Curtis dissimilarity, relative change in taxa abundance)
Time frame: 4 weeks
Vaginal pH
vaginal pH
Time frame: 4 weeks
GI microbiome
Microbiome diversity (e.g., α-diversity, β-diversity, Bray-Curtis dissimilarity, relative change in taxa abundance)
Time frame: 4 weeks
Vaginal health questionairre
Vaginal health visual analog score: itching, dryness, discharge, odor. This is a scale from 0-3 with 3 being the most bothersome score
Time frame: 4 weeks
Gastrointestinal Symptom Rating Scale (GSRS)
GI symptoms are measured using a Gastrointestinal Symptom Rating Scale (GSRS), which ranges from 1 to 7 per item, with higher scores indicating worse gastrointestinal symptoms
Time frame: 4 weeks
RAND SF-36 component scores
To assess overall physical and mental health-related quality of life, scores were reported using the RAND 36-Item Health Survey (SF-36), with Physical and Mental Component Summary scores ranging from 0 to 100, where higher scores indicate better health status
Time frame: 4 weeks
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Bristol Stool Scale score
Stool consistency was measured using the Bristol Stool Form Scale (BSFS), which categorizes stool into seven types ranging from 1 (hard, indicative of constipation) to 7 (liquid, indicative of diarrhea), with types 3 and 4 considered most typical of healthy bowel movements
Time frame: 4 weeks