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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Dietary Supplement: Juice daily consumption


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-menopausal status Exclusion Criteria: recent (6months) antibiotics or immunosuppressive therapies recent (6months) abdominal surgeries
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo juice<br> | Dietary Supplement: Juice daily consumption<br>* Single-service bottles of juice were provided for 15 days of daily consumption in each arm<br>|
| Active Comparator: Cranberry juice<br> | Dietary Supplement: Juice daily consumption<br>* Single-service bottles of juice were provided for 15 days of daily consumption in each arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |