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

Not Applicable
Completed
Conditions
Urinary Tract Infections
Interventions
Dietary Supplement: Juice daily consumption
Registration Number
NCT04680325
Lead Sponsor
University of Arkansas, Fayetteville
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

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
23
Inclusion Criteria
  • Post-menopausal status
Exclusion Criteria
  • recent (6months) antibiotics or immunosuppressive therapies
  • recent (6months) abdominal surgeries

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Placebo juiceJuice daily consumption-
Cranberry juiceJuice daily consumption-
Primary Outcome Measures
NameTimeMethod
Changes in the gut microbiota profile assessed by sequencing of stool samples4 weeks
Changes in the vaginal microbiota profile assessed by sequencing of swab samples4 weeks
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Arkansas

🇺🇸

Fayetteville, Arkansas, United States

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