MedDataX Logo

Laxation and Satiety Response of Novel Dietary Fibers

NCT ID: NCT01102881

Last Updated: 2010-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Dietary fibers have previously been shown to affect laxation and satiety. Due to differences in structure and physical properties of dietary fibers, these effects may not be consistent across all fibers. Therefore as new dietary fibers are created or discovered the laxative and satiating effects should be investigated in order to verify these effects.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study was designed to test the laxative effects of two fibers a resistant starch made from corn and a glucose polymer fiber. The secondary aim of this study was to examine the satieting effects of these fibers. This trial was double-blind and placebo controlled. On the first day of the study subjects consumed the breakfast cereal and milk and were instructed to complete visual analog scales periodically to test acute satiety. Subjects also completed diet records and tolerance questionnaires on days 1,2, and 10. Additionally subjects completed another satiety survey on day 10 to test chronic satiety. Whole gut transit time, fecal weight, and fecal chemistry was tested by swallowing radioopaque pellets on day 6 and collecting every fecal sample for the 5 days thereafter.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No fiber

No fiber added to muffins or cereal

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

low fiber breakfast cereal and muffin

Fiber made from corn starch

Muffins and cereal made with novel corn fiber

Group Type EXPERIMENTAL

Fiber made from corn starch

Intervention Type DIETARY_SUPPLEMENT

20 grams of fiber per day split into two 10 gram doses administered as a breakfast cereal and a muffin or no-fiber breakfast cereal and muffin

Glucose polymer fiber

Muffins and cereal made from glucose polymer fiber

Group Type EXPERIMENTAL

Glucose polymer fiber

Intervention Type DIETARY_SUPPLEMENT

20 grams of fiber per day split into two 10 gram doses administered as a breakfast cereal and a muffin or no-fiber breakfast cereal and muffin

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Glucose polymer fiber

20 grams of fiber per day split into two 10 gram doses administered as a breakfast cereal and a muffin or no-fiber breakfast cereal and muffin

Intervention Type DIETARY_SUPPLEMENT

Fiber made from corn starch

20 grams of fiber per day split into two 10 gram doses administered as a breakfast cereal and a muffin or no-fiber breakfast cereal and muffin

Intervention Type DIETARY_SUPPLEMENT

placebo

low fiber breakfast cereal and muffin

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Dietary fiber made from corn starch

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* healthy men and women
* age 18-65
* non-smoking
* not taking medication
* non-dieting (weight stable in prior 3 months)
* BMI 18-30
* English literacy

Exclusion Criteria

* do not regularly consume breakfast
* food allergies to ingredients found in study product
* dislike of cereal or muffins
* BMI \<18 or \>30
* diagnosed with cardiovascular, renal, or hepatic disease
* diabetes mellitus (fasting blood glucose \> 126 mg/ml)
* cancer in previous 5 years (except basal cell carcinoma of the skin)
* any gastrointestinal disease or condition
* recent bacterial infection (\< 3 months)
* recent or concurrent participation in an intervention research study
* history of drug or alcohol abuse in prior 6 months
* use of lipid-lowering, anti-hypertensive, or anti-inflammatory steroid medications vegetarians people who eat more than approximately 15 grams of dietary fiber per day women who are pregnant or lactating women with irregular menstrual cycles consumption of prebiotics or probiotics
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tate and Lyle Ingredients France

INDUSTRY

Sponsor Role collaborator

General Mills

INDUSTRY

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Minnesota

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joanne L Slavin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Minnesota

Saint Paul, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0902M60241

Identifier Type: -

Identifier Source: org_study_id