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OpenTrials
Completed

NCT Number: NCT01495182

Effects of Dietary Fiber on Gastrointestinal Function

The purpose of the study will be to assess the gastrointestinal effects of a dietary fiber in healthy, adult volunteers.

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Key information

Conditions

Gastrointestinal Health

Age range

18 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Provident Clinical Research and Consulting Inc

Glen Ellyn, Illinois, 60137, United States

About this study

The study is a blinded, cross-over design with subjects completing three, two-week treatment periods, separated by two, two-week washouts. Volunteers will consume a dietary fiber for two of the treatment periods at two dose levels. The fiber will be added to foods and dispensed to subjects to be consumed twice a day during each treatment period. During the control period, subjects will receive the same study foods, but with no added fiber. Major outcomes will include fecal weight, and responses to questionnaires that assess fecal characteristics, bowel habits and gastrointestinal tolerability.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy men and women
  • age 18 - 54 years
  • BMI < 30 kg/m2

Exclusion criteria

  • presence of GI or other serious diseases known to affect GI function
  • recent use of antibiotics
  • very high fiber intake
  • use of medications known to affect GI function
  • presence of allergies to study foods

Treatment and study plan

dietary fiber

Other

A proprietary fiber will be given to subjects

Primary outcomes

  1. Gastrointestinal tolerability

    Time frame: subjects will report weekly for 6 weeks

    Questionnaire to assess symptoms such as nausea, bloating, and flatulence

Secondary outcomes

  1. Fecal output

    Time frame: subjects will collect fecal output for 12 days within a six-week period

    Fecal weight and stool characteristics will be measured

Sponsors and collaborators

Lead sponsor

Ingredion Incorporated

Industry

Registry information

Official study title

A Double-blind, Randomized, Crossover Trial to Assess the Gastrointestinal Tolerability of a Dietary Fiber Ingredient in Healthy Men and Women

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 19, 2011
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.

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