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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 15, 2017

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

Interventions

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

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo juice
  • Active Comparator: Cranberry juice

Clinical Trial Outcome Measures

Primary Measures

  • Changes in the vaginal microbiota profile assessed by sequencing of swab samples
    • Time Frame: 4 weeks
  • Changes in the gut microbiota profile assessed by sequencing of stool samples
    • Time Frame: 4 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Post-menopausal status Exclusion Criteria:

  • recent (6months) antibiotics or immunosuppressive therapies – recent (6months) abdominal surgeries

Gender Eligibility: Female

Based on menopausal status

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Arkansas, Fayetteville
  • Collaborator
    • Ocean Spray, Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Franck, Assistant Professor – University of Arkansas, Fayetteville
  • Overall Official(s)
    • Franck Carbonero, Principal Investigator, Washington State University

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