Effects of a Dietary Fiber on Fecal Microbiota and Metabolism

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

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.

Study Overview

• Status: Completed
• Conditions: Focus of the Study is on Gut Health
• Intervention / Treatment: Dietary supplement: Dietary Fiber

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • USDA, ARS, Western Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolizable energy	Urine and feces will be collected for 7 days at the end of each treatment period to allow for assessment of metabolizable energy	7 days, 3 times
Fermentability	Breath hydrogen will be measured hourly, over eight hours at the end of each treatment period	One, eight-hr day, three times

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal microbiota	Fecal samples will be collected for 7 days at the end of each treatment period and for two days during washout periods	2 days, three times, and 7 days, three times
Blood glucose	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	For eight hours, three times

Collaborators and Investigators

• Sponsor: Ingredion Incorporated
• Investigators: Principal Investigator: Nancy Keim, PhD, ARS/USDA, University of California - Davis

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: January 20, 2012
• First Submitted That Met QC Criteria: January 24, 2012
• First Posted (Estimate): January 25, 2012

Study Record Updates

• Last Update Posted (Estimate): April 21, 2016
• Last Update Submitted That Met QC Criteria: April 20, 2016
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: PRT002