Prebiotic Effects of a Polyphenol-rich Food Product

NCT ID: NCT03659240

Last Updated: 2023-03-02

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

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-09

Study Completion Date

2019-02-24

Brief Summary

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The specific aim for this project will be to investigate a cranberry beverage as a means to restore balance in terms of the relative proportions of the various bacteria that inhabit the large intestine.

Detailed Description

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Conditions

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Dysbiosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Cranberry beverage

Group Type EXPERIMENTAL

Cranberry beverage

Intervention Type OTHER

During the intervention period, research participants will consume a cranberry beverage daily.

Placebo beverage

Group Type PLACEBO_COMPARATOR

Placebo beverage

Intervention Type OTHER

During the intervention period, research participants will consume a placebo beverage daily.

Interventions

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Cranberry beverage

During the intervention period, research participants will consume a cranberry beverage daily.

Intervention Type OTHER

Placebo beverage

During the intervention period, research participants will consume a placebo beverage daily.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* BMI 27-35 kg/m2
* High waist circumference (men \>102 cm and women \>88 cm)

Exclusion Criteria

* Cigarette smoking
* Regular intensive exercise
* Pregnancy or lactation
* Chronic diarrhea, constipation, or other gastrointestinal complaint
* Diabetes mellitus, autoimmune disease, or other chronic disease known to alter the gut microbiota
* Use of medications that affect inflammation or the gut microbiota
* Use of prebiotics, probiotics, synbiotics, vitamins, or other dietary supplements known to affect the gut microbiota
* Aversion to cranberries
* Food allergies
* Lactose intolerance
* Vegetarianism
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Iowa State University

OTHER

Sponsor Role lead

Responsible Party

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Wendy S. White

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nutrition and Wellness Research Center

Ames, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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18-303-00

Identifier Type: -

Identifier Source: org_study_id

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