Completed

Tolerance and Utilization of Polydextrose, Inulin, and Nutriose as Supplemental Fiber

Study Aim

This study aims to investigate how well your body tolerates and utilizes different types of supplemental fiber, specifically Polydextrose, Inulin, and Nutriose, by analyzing the bacteria present in your fecal samples and the products produced when these fibers are broken down.

What is being tested

polydextrose

+ soluble corn fiber

Other

Who is being recruted

From 20 to 40 Years

+4 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Placebo-Controlled

Interventional

Study Start: July 2010

See protocol details

Summary

Principal SponsorUniversity of Illinois at Urbana-Champaign

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2010

Actual date on which the first participant was enrolled.

This study focuses on the benefits of soluble fibers, specifically polydextrose, inulin, and nutriose, in maintaining gut health. These fibers are known to promote laxation and overall gastrointestinal health. The study aims to understand how these fibers affect protein and carbohydrate fermentation in the gut, potentially leading to a healthier microbial profile. By exploring the effects of nutriose and polydextrose as supplemental fibers in a human diet, researchers hope to uncover their potential in improving gut health and their application in the food industry. During the study, participants will receive polydextrose, inulin, and nutriose as supplemental fibers to their existing diet. The primary goal is to assess the tolerance of these fibers. Additionally, the study aims to understand how effectively the body utilizes polydextrose and nutriose. Participants will collect fecal samples during days 16-21 of each treatment period using provided materials. These samples will be analyzed for bacterial species and fermentation end products, providing insights into gut health and fiber utilization.

Official TitleTolerance and Utilization of Polydextrose, Inulin, and Soluble Corn Fiber

NCT02091349

Principal SponsorUniversity of Illinois at Urbana-Champaign

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

25 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Male

Biological sex of participants that are eligible to enroll.

From 20 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate

have body mass index (BMI) between 18.5 and 31 kg/m2

free of metabolic and gastrointestinal disease

2 exclusion criteria prevent from participating

BMI less than 18.5 or greater than 31 kg/m2

presence of metabolic or gastrointestinal diseases

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo

Participants in this group receive a snack bar or muffin without any fiber. This is a control group to compare the effects of fiber.

Group II

Experimental

Participants in this group receive varying doses of Polydextrose, a type of fiber that is not easily digested in the small intestine. They also receive Soluble Corn Fiber as part of the treatment.

Group III

Experimental

Participants in this group receive a type of fiber made from corn starch, called soluble corn fiber. This fiber contains oligosaccharides and may have small amounts of monosaccharides.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

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CompletedNo study centers