Working... Menu

Prebiotic Effects of a Polyphenol-rich Food Product

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03659240
Recruitment Status : Not yet recruiting
First Posted : September 6, 2018
Last Update Posted : September 6, 2018
Information provided by (Responsible Party):
Wendy S. White, Iowa State University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dysbiosis Other: Cranberry beverage Other: Placebo beverage Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prebiotic Effects of a Polyphenol-rich Food Product
Estimated Study Start Date : October 9, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : October 8, 2019

Arm Intervention/treatment
Experimental: Cranberry beverage Other: Cranberry beverage
During the intervention period, research participants will consume a cranberry beverage daily.

Placebo Comparator: Placebo beverage Other: Placebo beverage
During the intervention period, research participants will consume a placebo beverage daily.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Layout table for additonal information
Responsible Party: Wendy S. White, Associate Professor, Iowa State University Identifier: NCT03659240     History of Changes
Other Study ID Numbers: 18-303-00
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Pathologic Processes