Health TrialsbyHealthPanel

The Effect Cranberry-Based Products on the Female Microbiome

ConditionsVaginal MicrobiomeGut MicrobiomeGut Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorOcean Spray Cranberries, Inc.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active

    Dietary supplement

    Cranberry Beverage

  • Placebo

    Dietary supplement

    Placebo Beverage

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Cranberry beverageActive comparator 1 intervention
Group B: Placebo BeveragePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Vaginal Microbiome

The number of participants exhibiting a Lactobacillus-dominant CST vaginal microbiome following the 28-day intervention

Time frame
4 weeks

Secondary outcomes

1

Vaginal Microbiome Diversity

Microbiome diversity (e.g., α-diversity, β-diversity, Bray-Curtis dissimilarity, relative change in taxa abundance)

Time frame
4 weeks
2

Vaginal pH

vaginal pH

Time frame
4 weeks
3

GI microbiome

Microbiome diversity (e.g., α-diversity, β-diversity, Bray-Curtis dissimilarity, relative change in taxa abundance)

Time frame
4 weeks
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ocean Spray Cranberries, Inc.

Lead sponsor

Source ClinicalTrials.gov
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