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Effects of a Dietary Fiber on Fecal Microbiota and Metabolism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01518088
First Posted: January 25, 2012
Last Update Posted: April 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ingredion Incorporated
January 20, 2012
January 25, 2012
April 21, 2016
February 2012
December 2013   (Final data collection date for primary outcome measure)
  • Metabolizable energy [ Time Frame: 7 days, 3 times ]
    Urine and feces will be collected for 7 days at the end of each treatment period to allow for assessment of metabolizable energy
  • Fermentability [ Time Frame: One, eight-hr day, three times ]
    Breath hydrogen will be measured hourly, over eight hours at the end of each treatment period
Same as current
Complete list of historical versions of study NCT01518088 on ClinicalTrials.gov Archive Site
  • Fecal microbiota [ Time Frame: 2 days, three times, and 7 days, three times ]
    Fecal samples will be collected for 7 days at the end of each treatment period and for two days during washout periods
  • Blood glucose [ Time Frame: For eight hours, three times ]
    An indwelling catheter will be placed and blood samples will be drawn over the course of an eight-hour period, at the end of each treatment period
Same as current
Not Provided
Not Provided
 
Effects of a Dietary Fiber on Fecal Microbiota and Metabolism
Effects of a Dietary Fiber on Human Gut Microbiota, Bioactive Metabolites and Blood Glucose Control
The purpose of the study is to examine how a dietary fiber affects metabolism in healthy overweight and obese adults. The fiber will be added to foods that participants will consume for two, three-week periods. The fiber will be given in two doses -- 15 g per day during one period, and 30 g per day in the other. In another three-week period, they will consume the same foods, but with no fiber added. Major outcomes will include fermentability of the fiber, as assessed by measurement of breath hydrogen, as well as shifts in fecal bacteria. The caloric value of the fiber will be determined and metabolic measures related to blood glucose control and inflammation will also be taken.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Focus of the Study is on Gut Health
Dietary Supplement: Dietary Fiber
Dietary fiber will be added to study foods
  • Experimental: Low dose dietary fiber
    Intervention: Dietary Supplement: Dietary Fiber
  • Experimental: High dose dietary fiber
    Intervention: Dietary Supplement: Dietary Fiber
  • Placebo Comparator: No added fiber
    Intervention: Dietary Supplement: Dietary Fiber
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2013
December 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Body mass index from 25 to 35 kg/m2.
  • Willing to consume study foods and comply with dietary exclusions and specimen collection

Exclusion Criteria:

  • Pregnancy
  • Diabetes
  • Gastrointestinal disease
  • Regular use of pre- or probiotics
  • Recent use of antibiotics
  • High intake of dietary fiber
Sexes Eligible for Study: All
20 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01518088
PRT002
No
Not Provided
Not Provided
Ingredion Incorporated
Ingredion Incorporated
Not Provided
Principal Investigator: Nancy Keim, PhD ARS/USDA, University of California - Davis
Ingredion Incorporated
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP