Clinical trial NCT04680325: 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
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Lead sponsor: University of Arkansas, Fayetteville
Sponsor class: OTHER
Collaborators: name: Ocean Spray, Inc.
First posted: 2020-12-22
Enrollment: 23
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: Inclusion Criteria:

* Post-menopausal status

Exclusion Criteria:

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

Primary outcomes:
measure: Changes in the vaginal microbiota profile assessed by sequencing of swab samples
timeFrame: 4 weeks
measure: Changes in the gut microbiota profile assessed by sequencing of stool samples
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas
state: Arkansas
Study officials:
affiliation: Washington State University
name: Franck Carbonero
role: PRINCIPAL_INVESTIGATOR
References: