Gut Health Response to Dietary Fiber

December 5, 2013 updated by: University of Minnesota

Gut Health Response to a New Fiber Blend

Dietary fiber is known to influence bowel function. The investigators hypothesize that the addition of a mixture of fibers to liquid diets will improve bowel function as measured by stool weight.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Liquid diets are the sole source of nutrition for many patients. Consumption of liquid diets is linked to lower stool weight. The objective of this study is to feed liquid diets, with and without added fiber, to healthy human subjects to determine if mixed fiber sources can normalize stool weight. Secondary objectives of the study include measurement of gut microbiota and stool chemistry with fiber addition.

Study Type

Interventional

Enrollment (Anticipated)

20

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
    • Minnesota
      • St. Paul, Minnesota, United States, 55108
        • University of Minnesota

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 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

1.Weight

  • BMI between 23 - 29
  • having obtained his/her informed consent
  • willing and able to exclusively consume enteral diets for two 14 day periods
  • willing and able to collect stool samples as instructed

Exclusion Criteria:

  • any disease
  • use of medication except for contraceptive medication and certain OTC medications not affecting laxation
  • smoking
  • excessive exercise (> 2 hours per week)
  • consumption of more than 20 grams of dietary fiber daily
  • pregnancy or lactation
  • use of laxatives
  • use of antibiotics in past 6 months
  • use of pre or probiotics supplements in the past 2 months
  • use of probiotic foods in the past month
  • subjects who cannot be expected to comply with the study procedures
  • currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
  • known allergy or sensitivity to formula ingredients

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
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stool weight
Time Frame: 5 day collection
5 day fecal collection on last 5 days of 14 day feeding trial
5 day collection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fecal microbiota
Time Frame: day 14 of feeding trial
fecal sample on last day of feeding trial will be collected for microbiota analysis
day 14 of feeding trial

Collaborators and Investigators

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

Sponsor

University of Minnesota

Collaborators

Nestlé

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2011

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

March 22, 2011

First Submitted That Met QC Criteria

March 22, 2011

First Posted (ESTIMATE)

March 23, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 6, 2013

Last Update Submitted That Met QC Criteria

December 5, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1103M96878

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.

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