The Effect Cranberry-Based Products on the Female Microbiome

Not Applicable

Recruiting

• Conditions: Vaginal Microbiome; Gut Microbiome; Gut Health

• Registration Number: NCT07109713
• Lead Sponsor: Ocean Spray Cranberries, Inc.

Brief 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

Detailed 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, 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 Timeline

• Study First Submitted: 2025-07-31
• Study First Submitted QC: 2025-07-31
• Status Verified: 2025-08
• Study Start: 2025-08-05
• Study First Posted: 2025-08-07
• Last Update Submitted: 2025-08-11
• Last Update Posted: 2025-08-14
• Primary Completion: 2025-12-19
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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, including lifestyle considerations (see section 6.2), and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.

Exclusion Criteria

Women's health related criteria

•Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.

General health related criteria

• Participant has a history or presence of any gastrointestinal condition that could potentially interfere with absorption of the study product (e.g., inflammatory bowel syndrome, celiac disease, history of gastric bypass surgery).
• History or presence of clinically important cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, gastrointestinal, biliary, pancreatic, or neurological disorders that may affect the participant's ability to adhere to the study protocol and/or affect study outcomes, in the judgment of the Investigator.
• Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at visit •Stable use of hypertension medication is allowed (defined as no change in medication regimen ≤ 90 d of visit 1).
• Any signs or symptoms of active infection of clinical relevance (e.g., urinary tract or respiratory) within 5 days prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved and any treatment has been completed at least 5 days prior to testing.
• History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
• History of any major trauma or major surgical event within 2 months of visit 1.
• Subject has elective hospitalizations planned (e.g., elective cosmetic procedures) during the study period.
• Underwent an endoscopy or colonoscopy preparation within 3 months prior to visit 1.

Exclusionary products related criteria

• Recent history of (within 12 months of screening; visit 1) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
• Use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1.
• Habitual users (i.e., daily or almost daily) of marijuana and hemp products, including CBD products, and willing to abstain from use throughout the study period (topical creams/lotions are allowed). Occasional use (e.g., couple times a month) within 12 months of visit 1 is allowed but requires at least a 14 d washout prior to visit 1 and the participant must be willing to refrain from use during the study.
• Unstable use of any prescription medication, where stable use is defined as no change in dose or medication type within 90 days of visit 1. This exclusion criterion does not include hormonal contraceptives.
• Exposed to any non-registered drug product within 30 days prior to visit 1.
• Antibiotic use within 30 d of visit 1 and throughout the study period.
• Steroid use within 30 d of visit 1 and throughout the study period.
• Current habitual user (≥ 3 days/week ≤ 1 month of visit 1) of anti-inflammatory medications (e.g., NSAIDs, acetaminophen, etc.).
• Use of medications (over-the-counter or prescription) and/or dietary supplements, known to influence GI function, including but not limited to, pre-, post-, and probiotic supplements, fiber supplements, laxatives, enemas, suppositories, H2 blockers, proton pump inhibitors, antacids, anti-diarrheal agents, anti-depressants, and/or anti-spasmodic within 30 d of visit 1 and throughout the study period. Standard multivitamin and mineral supplements are allowed.
• Willing to avoid consuming probiotics or fermented foods within 14 d of visit 1 and throughout the study period.
• Willing to avoid consuming high-polyphenol foods and supplements [e.g., dark colored and polyphenol-rich fruits (berries, grapes, pomegranates, cherries, grapefruit, black currant, plum) and their processed food/juice and related supplement products (e.g. grape seed extract, green tea extract); red wine; dark chocolate; cranberry extract supplements] throughout the study period.

General safety related criteria

• Known sensitivity, intolerability, or allergy to any of the study products or their excipients.
• Any condition the Investigator believes would interfere with the participant's ability to provide informed consent or comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Vaginal Microbiome	4 weeks	The number of participants exhibiting a Lactobacillus-dominant CST vaginal microbiome following the 28-day intervention

Secondary Outcome Measures

Name	Time	Method
Vaginal Microbiome Diversity	4 weeks	Microbiome diversity (e.g., α-diversity, β-diversity, Bray-Curtis dissimilarity, relative change in taxa abundance)
Vaginal pH	4 weeks	vaginal pH
GI microbiome	4 weeks	Microbiome diversity (e.g., α-diversity, β-diversity, Bray-Curtis dissimilarity, relative change in taxa abundance)
Vaginal health questionairre	4 weeks	Vaginal health visual analog score: itching, dryness, discharge, odor. This is a scale from 0-3 with 3 being the most bothersome score
Gastrointestinal Symptom Rating Scale (GSRS)	4 weeks	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
RAND SF-36 component scores	4 weeks	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
Bristol Stool Scale score	4 weeks	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

Trial Locations

Locations (1)

Biofortis; 🇺🇸 Chicago, Illinois, United States