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Gut Health Response to Dietary Fiber

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ClinicalTrials.gov Identifier: NCT01321736
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : December 6, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Dietary Fiber Dietary Supplement: dietary fiber

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Gut Health Response to a New Fiber Blend
Study Start Date : April 2011
Primary Completion Date : May 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Dietary Supplement: dietary fiber
    mixture of fiber sources added to liquid nutrition product
    Other Name: mixed fibers include fructans, soluble fiber, and insoluble fiber

Outcome Measures

Primary Outcome Measures :
  1. Stool weight [ Time Frame: 5 day collection ]
    5 day fecal collection on last 5 days of 14 day feeding trial


Secondary Outcome Measures :
  1. fecal microbiota [ Time Frame: day 14 of feeding trial ]
    fecal sample on last day of feeding trial will be collected for microbiota analysis


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321736


Locations
United States, Minnesota
University of Minnesota
St. Paul, Minnesota, United States, 55108
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Nestlé
Investigators
Principal Investigator: Joanne Slavin, PhD University of Minnesota - Clinical and Translational Science Institute
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01321736     History of Changes
Other Study ID Numbers: 1103M96878
First Posted: March 23, 2011    Key Record Dates
Last Update Posted: December 6, 2013
Last Verified: December 2013

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
dietary fiber
enteral nutrition
laxation