NCT04680325

Brief Summary

This study was a randomized, placebo-controlled, crossover, pilot dietary intervention. Ocean Spray Cranberries, Inc provided the experimental and placebo beverages, which have been validated and used in previous studies \[26-29\]. Both beverages were similar in appearance, taste, and aroma and assigned to volunteers according to computer-generated random orders. Both investigators and participants were blind to the assignment and products are identified by a random 3-digit code pre-printed on the cap. The participants consumed either cranberry juice or placebo beverage daily (8 fl oz per day) for 15 days

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

December 16, 2020

Last Update Submit

December 21, 2020

Conditions

Urinary Tract Infections

Outcome Measures

Primary Outcomes (2)

  • Changes in the vaginal microbiota profile assessed by sequencing of swab samples

    4 weeks

  • Changes in the gut microbiota profile assessed by sequencing of stool samples

    4 weeks

Study Arms (2)

Placebo juice

PLACEBO COMPARATOR
Dietary Supplement: Juice daily consumption

Cranberry juice

ACTIVE COMPARATOR
Dietary Supplement: Juice daily consumption

Interventions

Juice daily consumptionDIETARY_SUPPLEMENT

Single-service bottles of juice were provided for 15 days of daily consumption in each arm

Cranberry juicePlacebo juice

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBased on menopausal status
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Post-menopausal status

You may not qualify if:

  • recent (6months) antibiotics or immunosuppressive therapies
  • recent (6months) abdominal surgeries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas

Fayetteville, Arkansas, 72701, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Franck Carbonero

    Washington State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 16, 2020

First Posted

December 22, 2020

Study Start

July 1, 2017

Primary Completion

November 15, 2017

Study Completion

August 31, 2018

Last Updated

December 22, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)