We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
  Purpose
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.

Condition Intervention
Focus of the Study is on Gut Health Dietary Supplement: Dietary Fiber

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of a Dietary Fiber on Human Gut Microbiota, Bioactive Metabolites and Blood Glucose Control

Resource links provided by NLM:


Further study details as provided by Ingredion Incorporated:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 20
Study Start Date: February 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose dietary fiber Dietary Supplement: Dietary Fiber
Dietary fiber will be added to study foods
Experimental: High dose dietary fiber Dietary Supplement: Dietary Fiber
Dietary fiber will be added to study foods
Placebo Comparator: No added fiber Dietary Supplement: Dietary Fiber
Dietary fiber will be added to study foods

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  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): NCT01518088


Locations
United States, California
USDA, ARS, Western Human Nutrition Research Center
Davis, California, United States, 95616
Sponsors and Collaborators
Ingredion Incorporated
Investigators
Principal Investigator: Nancy Keim, PhD ARS/USDA, University of California - Davis
  More Information

Responsible Party: Ingredion Incorporated
ClinicalTrials.gov Identifier: NCT01518088     History of Changes
Other Study ID Numbers: PRT002
First Submitted: January 20, 2012
First Posted: January 25, 2012
Last Update Posted: April 21, 2016
Last Verified: January 2012