60 Participants Needed

Cranberry-Based Products for Gut and Vaginal Health

LC
CK
Overseen ByChristina Khoo, PhD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Ocean Spray Cranberries, Inc.

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how cranberry-based products affect gut and vaginal health in women. Participants will receive either a cranberry beverage or a placebo drink to observe any differences in health outcomes. The researchers seek to understand how these products might improve the balance of bacteria in the gut and vagina, as well as overall well-being. The trial is recruiting pre-menopausal women with regular menstrual cycles and no major digestive health issues. As an unphased trial, it offers participants the chance to contribute to groundbreaking research on natural health solutions.

Will I have to stop taking my current medications?

The trial requires that you have stable use of any prescription medication, meaning no changes in dose or type within 90 days before starting the study. Some medications, like antibiotics, steroids, and certain GI-related medications, must be stopped 30 days before the study and throughout its duration.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cranberry products are generally safe for most people. The FDA considers whole cranberries and cranberry juice safe. Studies indicate that consuming large amounts of cranberry juice might cause mild stomach upset, though this is uncommon. Cranberry products are usually well-tolerated, with any side effects typically being minor. Therefore, participating in a trial with cranberry-based products is likely safe for most healthy adults.12345

Why are researchers excited about this trial?

Researchers are excited about cranberry-based products because they offer a natural approach to improving gut and vaginal health. Unlike standard treatments that often involve antibiotics or synthetic supplements, cranberry beverages contain unique compounds like proanthocyanidins, which may prevent harmful bacteria from sticking to the body’s surfaces. This natural mechanism could reduce the need for more aggressive treatments, potentially lowering the risk of side effects and antibiotic resistance. Plus, the pleasant taste and ease of incorporating these beverages into daily life could boost adherence and overall effectiveness.

What evidence suggests that cranberry-based products might be an effective treatment for gut and vaginal health?

This trial will compare the effects of a cranberry beverage with a placebo beverage on gut and vaginal health. Studies have shown that cranberry-based products benefit gut health by altering the types and amounts of bacteria in the gut. Research indicates that the natural compounds in cranberries can reduce intestinal swelling and improve gut function. Evidence also suggests that cranberry products might help maintain the balance of good bacteria in the vagina, which is crucial for health. Furthermore, some studies have found that components of cranberries can enhance the effectiveness of antibiotics, making them a promising option for managing and preventing certain bacterial issues. Overall, these findings suggest that cranberry products have potential for improving gut and vaginal health.26789

Who Is on the Research Team?

EA

Elizabeth Antoo, MD

Principal Investigator

BioFortis

Are You a Good Fit for This Trial?

This trial is for pre-menopausal women aged 18-45 with regular menstrual cycles and a BMI of ≥18.5 to <30.0 kg/m2. Participants must not use certain medications, probiotics, or have conditions affecting GI function, be pregnant or unwilling to use contraception, and should not consume high-polyphenol foods during the study.

Inclusion Criteria

History of regular menstrual cycles for at least 3 months prior to visit 1
I am a woman aged 18-45 and have not gone through menopause.
BMI ≥18.5 to <30.0 kg/m2 at visit 1
See 1 more

Exclusion Criteria

Habitual use of marijuana and hemp products
Consumption of probiotics or fermented foods within 14 days of visit 1 and throughout the study period
Any condition that may interfere with providing informed consent or complying with the study protocol
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either an 8 oz cranberry beverage or placebo beverage daily to assess effects on vaginal and GI microbiome

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cranberry-Based Products
Trial Overview The trial aims to compare the effects of a cranberry-based product versus a placebo on vaginal and gastrointestinal microbiomes in healthy women. It will also assess participant-reported outcomes related to these microbiome changes.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: Cranberry beverageActive Control1 Intervention
Group II: Placebo BeveragePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ocean Spray Cranberries, Inc.

Lead Sponsor

Trials
7
Recruited
520+

Citations

Impact of Cranberries on Gut Microbiota and Cardiometabolic ...Recent advances in cranberry research have expanded the evidence for the role of this Vaccinium berry fruit in modulating gut microbiota function and ...
Short term supplementation with cranberry extract ...This finding suggests that cranberry supplementation influenced the overall composition and structure of the gut microbiota. In the V1 samples, ...
High polyphenolic cranberry beverage alters specific fecal ...Polyphenol-rich cranberry extracts decrease intestinal inflammation, alter gut microbiota, and decrease intestinal permeability in obese mice.
Assessing the treatment effect of cranberry type A ...This study revealed that A-PACs in cranberry juice combined with azole antibiotics can be used as a novel therapeutic option for the treatment and prevention ...
Cranberry-Based Products Effects on Female MicrobiomeThis study explores how different cranberry-based products may affect the microbiome, specifically in women. The microbiome is the community ...
Health Claim Petition - Consumption of Cranberry Products ...FDA agrees that whole cranberry fruit and cranberry juice are GRAS, and that powdered whole cranberries are safe and lawful for use in dietary ...
Impact of cranberry juice consumption on gut and vaginal ...These data suggest that cranberry consumption may improve vaginal microbiota composition in individuals with dysbiosis.
Cranberry - Uses, Side Effects, and MoreCranberry juice and cranberry extracts are likely safe for most adults. Drinking too much cranberry juice might cause some side effects such as mild stomach ...
Cranberry-derived bioactives for the prevention and ...Cranberry-derived bioactive compounds, particularly proanthocyanidins (PACs), have emerged as a promising non-antibiotic strategy for UTI prevention.
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