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Prebiotic Effects of a Polyphenol-rich Food Product

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ClinicalTrials.gov Identifier: NCT03659240
Recruitment Status : Not yet recruiting
First Posted : September 6, 2018
Last Update Posted : September 6, 2018
Sponsor:
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

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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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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Responsible Party: Wendy S. White, Associate Professor, Iowa State University
ClinicalTrials.gov 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dysbiosis
Pathologic Processes