Prebiotic Effects of a Polyphenol-rich Food Product

February 28, 2023 updated by: Wendy S. White, Iowa State University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Ames, Iowa, United States, 50011
        • Nutrition and Wellness Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo beverage
Other: Placebo beverage
During the intervention period, research participants will consume a placebo beverage daily.
Experimental: Cranberry beverage
Other: Cranberry beverage
During the intervention period, research participants will consume a cranberry beverage daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal microbial community composition and structure
Time Frame: Changes in the fecal microbiota will be measured after a 20-day intervention period
We will investigate if specific bacterial taxa are stimulated by daily consumption of a cranberry beverage.
Changes in the fecal microbiota will be measured after a 20-day intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iowa State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2018

Primary Completion (Actual)

February 24, 2019

Study Completion (Actual)

February 24, 2019

Study Registration Dates

First Submitted

September 3, 2018

First Submitted That Met QC Criteria

September 3, 2018

First Posted (Actual)

September 6, 2018

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-303-00

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dysbiosis

Clinical Trials on Cranberry beverage

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe