Effects of a Dietary Fiber on Fecal Microbiota and Metabolism

NCT ID: NCT01518088

Last Updated: 2016-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-12-31

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.

Conditions

Focus of the Study is on Gut Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Low dose dietary fiber

Group Type: EXPERIMENTAL

Dietary Fiber

Intervention Type: DIETARY_SUPPLEMENT

Dietary fiber will be added to study foods

High dose dietary fiber

Group Type: EXPERIMENTAL

Dietary Fiber

Intervention Type: DIETARY_SUPPLEMENT

Dietary fiber will be added to study foods

No added fiber

Group Type: PLACEBO_COMPARATOR

Dietary Fiber

Intervention Type: DIETARY_SUPPLEMENT

Dietary fiber will be added to study foods

Interventions

Dietary Fiber

Dietary fiber will be added to study foods

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ingredion Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nancy Keim, PhD

Role: PRINCIPAL_INVESTIGATOR

ARS/USDA, University of California - Davis

Locations

USDA, ARS, Western Human Nutrition Research Center

Davis, California, United States

Countries

United States

Other Identifiers

PRT002

Identifier Type: -

Identifier Source: org_study_id