Impact of Cranberry Juice Consumption on Gut and Vaginal... | NCT04680325

Studies
Impact of Cranberry Juice Consumption on Gut and Vaginal Microbiota in Post-menopausal Women

NCT04680325

Sponsor

University of Arkansas, Fayetteville

Status

Completed

Last Update Posted

Dec 22, 2020Actual

Enrollment

23Actual

Phase

Not Applicable

Conditions

Urinary Tract Infections

Interventions

Juice daily consumption

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2017Actual

Primary Completion Date

Nov 15, 2017Actual

Completion Date

Aug 31, 2018Actual

First Submitted Date

Dec 16, 2020

First Submission Date that Met QC Criteria

Dec 21, 2020

First Posted Date

Dec 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2020

Last Update Posted Date

Dec 22, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Franck, Assistant Professor, University of Arkansas, FayettevillePrincipal Investigator

Lead Sponsor

University of Arkansas, FayettevilleOTHER

Collaborators

Name	Class
Ocean Spray, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

This was a prospective exploratory pilot study with a dietary intervention. Twenty-three (23) women volunteered and participated in this study. The eligibility (no menstrual period for at least 12 months) of the participants was determined using a questionnaire. The participants were postmenopausal women between the ages of 50-75 years old who met the exclusion criteria including no recent antibiotics or immunosuppressive therapies, surgery of the stomach, small or large intestines, appendectomy, gastric bypass or gastric banding in the previous 6 months, and diagnostic with any autoimmune diseases.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo juice	Placebo Comparator		Dietary Supplement: Juice daily consumption
Cranberry juice	Active Comparator		Dietary Supplement: Juice daily consumption

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Juice daily consumption	Dietary Supplement	Single-service bottles of juice were provided for 15 days of daily consumption in each arm	Cranberry juice Placebo juice

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Post-menopausal status

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Based on menopausal status

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Franck Carbonero	Washington State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Arkansas		Fayetteville	Arkansas	72701	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014552	Urinary Tract Infections

Ancestor Terms

ID	Term
D007239	Infections
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

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Browse Branches

Not provided