Back to resultsImpact of Cranberry Juice Consumption on Gut and Vaginal Microbiota in Post-menopausal Women
Primary Purpose
Urinary Tract Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Juice daily consumption
Sponsored by
About this trial
This is an interventional basic science trial for Urinary Tract Infections
Eligibility Criteria
Inclusion Criteria:
- Post-menopausal status
Exclusion Criteria:
- recent (6months) antibiotics or immunosuppressive therapies
- recent (6months) abdominal surgeries
Sites / Locations
- University of Arkansas
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo juice
Cranberry juice
Arm Description
Outcomes
Primary Outcome Measures
Changes in the vaginal microbiota profile assessed by sequencing of swab samples
Changes in the gut microbiota profile assessed by sequencing of stool samples
Secondary Outcome Measures
Full Information
NCT ID
NCT04680325
First Posted
December 16, 2020
Last Updated
December 21, 2020
Sponsor
University of Arkansas, Fayetteville
Collaborators
Ocean Spray, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04680325
Brief Title
Impact of Cranberry Juice Consumption on Gut and Vaginal Microbiota in Post-menopausal Women
Official Title
Impact of Cranberry Juice Consumption on Gut and Vaginal Microbiota in Post-menopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
November 15, 2017 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arkansas, Fayetteville
Collaborators
Ocean Spray, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo juice
Arm Type
Placebo Comparator
Arm Title
Cranberry juice
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Juice daily consumption
Intervention Description
Single-service bottles of juice were provided for 15 days of daily consumption in each arm
Primary Outcome Measure Information:
Title
Changes in the vaginal microbiota profile assessed by sequencing of swab samples
Time Frame
4 weeks
Title
Changes in the gut microbiota profile assessed by sequencing of stool samples
Time Frame
4 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Based on menopausal status
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Post-menopausal status
Exclusion Criteria:
recent (6months) antibiotics or immunosuppressive therapies
recent (6months) abdominal surgeries
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck Carbonero
Organizational Affiliation
Washington State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72701
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Cranberry Juice Consumption on Gut and Vaginal Microbiota in Post-menopausal Women
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