The Effect Cranberry-Based Products on the Female Microbiome

Ocean Spray Cranberries

Status: Enrolling

Conditions: Gut Microbiome; Vaginal Microbiome; Gut Health

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Active

Study type: Interventional

Funder types: Industry

Identifiers

NCT07109713

Bio-2502

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Cranberry beverage

Active Comparator group

Description:

Participant will receive 8 oz of cranberry beverage to consume each day

Treatment:

Dietary Supplement: Active

Placebo Beverage

Placebo Comparator group

Description:

Participant will receive 8 oz of placebo beverage to consume each day

Treatment:

Dietary Supplement: Placebo