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

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04680325
• Other study ID #: Ocean Spray
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: December 2020
• Source: University of Arkansas, Fayetteville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 31, 2018
• Est. primary completion date: November 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Post-menopausal status

Exclusion Criteria:

• recent (6months) antibiotics or immunosuppressive therapies

• recent (6months) abdominal surgeries

Related Conditions & MeSH terms

• Urinary Tract Infections

Intervention

Dietary Supplement:
• Juice daily consumption
Single-service bottles of juice were provided for 15 days of daily consumption in each arm

Locations

Country	Name	City	State
United States	University of Arkansas	Fayetteville	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas, Fayetteville	Ocean Spray, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the vaginal microbiota profile assessed by sequencing of swab samples		4 weeks
Primary	Changes in the gut microbiota profile assessed by sequencing of stool samples		4 weeks