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Clinical Trials/NCT01518088
NCT01518088
Completed
Not Applicable

Effects of a Dietary Fiber on Human Gut Microbiota, Bioactive Metabolites and Blood Glucose Control

Ingredion Incorporated1 site in 1 country20 target enrollmentFebruary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Focus of the Study is on Gut Health
Sponsor
Ingredion Incorporated
Enrollment
20
Locations
1
Primary Endpoint
Metabolizable energy
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
December 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Pregnancy
  • Gastrointestinal disease
  • Regular use of pre- or probiotics
  • Recent use of antibiotics
  • High intake of dietary fiber

Outcomes

Primary Outcomes

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 Outcomes

  • Blood glucose(For eight hours, three times)
  • Fecal microbiota(2 days, three times, and 7 days, three times)

Study Sites (1)

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