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Gut Health Response to Dietary Fiber

This study has been completed.
Sponsor:
Collaborator:
Nestlé
Information provided by (Responsible Party):
Joanne L. Slavin, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01321736
First received: March 22, 2011
Last updated: February 8, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Dietary Fiber
 Dietary Supplement: dietary fiber

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Gut Health Response to a New Fiber Blend

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Stool weight [ Time Frame: 5 day collection ] [ Designated as safety issue: No ]
    5 day fecal collection on last 5 days of 14 day feeding trial


Secondary Outcome Measures:
  • fecal microbiota [ Time Frame: day 14 of feeding trial ] [ Designated as safety issue: No ]
    fecal sample on last day of feeding trial will be collected for microbiota analysis


Estimated Enrollment: 20
Study Start Date: April 2011
Study Completion Date: December 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Joanne L. Slavin, Professor, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01321736     History of Changes
Other Study ID Numbers: 1103M96878
Study First Received: March 22, 2011
Last Updated: February 8, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013