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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 National Starch LLC:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 20
Study Start Date: February 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (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

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518088

Contacts
Contact: Ellen Bonnel 530-752-4182 ellen.bonnel@ars.usda.gov

Locations
United States, California
USDA, ARS, Western Human Nutrition Research Center Not yet recruiting
Davis, California, United States, 95616
Contact: Ellen Bonnel    530-752-4184      
Principal Investigator: Nancy Keim, PhD         
Sponsors and Collaborators
National Starch LLC
Investigators
Principal Investigator: Nancy Keim, PhD ARS/USDA, University of California - Davis
  More Information

Additional Information:
No publications provided

Responsible Party: National Starch LLC
ClinicalTrials.gov Identifier: NCT01518088     History of Changes
Other Study ID Numbers: PRT002
Study First Received: January 20, 2012
Last Updated: January 24, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 25, 2014