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OpenTrials
Completed

NCT Number: NCT01518088

Effects of a Dietary Fiber on Fecal Microbiota and Metabolism

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.

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Key information

Conditions

Focus of the Study is on Gut Health

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA, ARS, Western Human Nutrition Research Center

Davis, California, 95616, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary fiber

Dietary Supplement

Dietary fiber will be added to study foods

Primary outcomes

  1. 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

  2. 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

  1. Fecal microbiota

    Time frame: 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

  2. Blood glucose

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ingredion Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 25, 2012
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.