Effects of a Dietary Fiber on Fecal Microbiota and Metabolism

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by National Starch LLC.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
National Starch LLC
ClinicalTrials.gov Identifier:
NCT01518088
First received: January 20, 2012
Last updated: January 24, 2012
Last verified: January 2012

January 20, 2012
January 24, 2012
February 2012
December 2012   (final data collection date for primary outcome measure)
  • Metabolizable energy [ Time Frame: 7 days, 3 times ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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.
 
Not yet recruiting
20
December 2012
December 2012   (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
Both
20 Years to 60 Years
Yes
Contact: Ellen Bonnel 530-752-4182 ellen.bonnel@ars.usda.gov
United States
 
NCT01518088
PRT002
No
National Starch LLC
National Starch LLC
Not Provided
Principal Investigator: Nancy Keim, PhD ARS/USDA, University of California - Davis
National Starch LLC
January 2012

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