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Prebiotic Effects of a Polyphenol-rich Food Product

Primary Purpose

Dysbiosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cranberry beverage
Placebo beverage
Sponsored by
Iowa State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dysbiosis

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nutrition and Wellness Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cranberry beverage

Placebo beverage

Arm Description

Outcomes

Primary Outcome Measures

Fecal microbial community composition and structure
We will investigate if specific bacterial taxa are stimulated by daily consumption of a cranberry beverage.

Secondary Outcome Measures

Full Information

First Posted
September 3, 2018
Last Updated
February 28, 2023
Sponsor
Iowa State University
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1. Study Identification

Unique Protocol Identification Number
NCT03659240
Brief Title
Prebiotic Effects of a Polyphenol-rich Food Product
Official Title
Prebiotic Effects of a Polyphenol-rich Food Product
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 9, 2018 (Actual)
Primary Completion Date
February 24, 2019 (Actual)
Study Completion Date
February 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Iowa State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysbiosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cranberry beverage
Arm Type
Experimental
Arm Title
Placebo beverage
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Cranberry beverage
Intervention Description
During the intervention period, research participants will consume a cranberry beverage daily.
Intervention Type
Other
Intervention Name(s)
Placebo beverage
Intervention Description
During the intervention period, research participants will consume a placebo beverage daily.
Primary Outcome Measure Information:
Title
Fecal microbial community composition and structure
Description
We will investigate if specific bacterial taxa are stimulated by daily consumption of a cranberry beverage.
Time Frame
Changes in the fecal microbiota will be measured after a 20-day intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Nutrition and Wellness Research Center
City
Ames
State/Province
Iowa
ZIP/Postal Code
50011
Country
United States

12. IPD Sharing Statement

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Prebiotic Effects of a Polyphenol-rich Food Product

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