Effects of a Dietary Fiber on Fecal Microbiota and Metabolism

Not Applicable

Completed

• Conditions: Focus of the Study is on Gut Health
• Interventions: Dietary Supplement: Dietary Fiber

• Registration Number: NCT01518088
• Lead Sponsor: Ingredion Incorporated

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-01
• Study First Submitted: 2012-01-20
• Study First Submitted QC: 2012-01-24
• Study First Posted: 2012-01-25
• Study Start: 2012-02
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2016-04-20
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High dose dietary fiber	Dietary Fiber	-
No added fiber	Dietary Fiber	-
Low dose dietary fiber	Dietary Fiber	-

Primary Outcome Measures

Name	Time	Method
Metabolizable energy	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	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

Name	Time	Method
Blood glucose	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
Fecal microbiota	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

Trial Locations

Locations (1)

USDA, ARS, Western Human Nutrition Research Center; 🇺🇸 Davis, California, United States