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

NCT ID: NCT04680325

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-08-31

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

Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo juice

Group Type PLACEBO_COMPARATOR

Juice daily consumption

Intervention Type DIETARY_SUPPLEMENT

Single-service bottles of juice were provided for 15 days of daily consumption in each arm

Cranberry juice

Group Type ACTIVE_COMPARATOR

Juice daily consumption

Intervention Type DIETARY_SUPPLEMENT

Single-service bottles of juice were provided for 15 days of daily consumption in each arm

Interventions

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Juice daily consumption

Single-service bottles of juice were provided for 15 days of daily consumption in each arm

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Post-menopausal status

Exclusion Criteria

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

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ocean Spray, Inc.

INDUSTRY

Sponsor Role collaborator

University of Arkansas, Fayetteville

OTHER

Sponsor Role lead

Responsible Party

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Franck

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Franck Carbonero

Role: PRINCIPAL_INVESTIGATOR

Washington State University

Locations

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University of Arkansas

Fayetteville, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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Ocean Spray

Identifier Type: -

Identifier Source: org_study_id