Satiety, Glycemic, and Gastrointestinal Effects of Novel Fibers

February 3, 2012 updated by: University of Minnesota

Research suggests dietary fiber may play a role in weight management, and fiber consumption is inversely associated with body weight, body fat, and BMI in cross-sectional studies. These effects may be mediated by increased satiety, reduced food intake, or changes in blood levels of glucose, insulin, and gut hormones.

The purpose of this study is to determine the satiety, glycemic, hormonal, and gastrointestinal responses of novel fiber supplements.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota - General Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy men and women
  • age 18-60 years
  • non-smoking
  • not taking medication
  • non-dieting (weight stable in prior 3 months)
  • BMI 18-27
  • English literacy
  • ability to give blood

Exclusion Criteria:

  • do not regularly consume breakfast
  • food allergies to ingredients found in study products
  • dislike for muffins, fiber bars, or hot cereal
  • BMI <18 or >27
  • diagnosed cardiovascular, renal, or hepatic disease
  • diabetes mellitus (fasting blood sugar >126 mg/dl)
  • 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 medication
  • restrained eaters
  • vegetarians
  • people who eat more than approximately 15 grams of fiber per day
  • women who are pregnant or lactating
  • women with irregular menstrual cycles

Study Plan

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

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: No fiber
No fiber added to study products
Dietary supplement: Placebo
Low fiber muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)
Experimental: Resistant Starch
Muffins, cereal, and bars made with a resistant starch
Dietary supplement: Resistant Starch
25 g resistant starch, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)
Experimental: Resistant starch + soluble fiber
Muffins, cereal, and bars made with a mixture of resistant starch and a soluble fiber
Dietary supplement: Resistant starch + soluble fiber
25 g fiber as resistant starch and a soluble fiber, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)
Experimental: Fiber made from corn starch
Muffins, cereal, and bars made with novel corn fiber
Dietary supplement: Fiber made from corn starch
25 g fiber made from corn starch, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)
Experimental: Fiber made from corn starch + soluble fiber
Muffins, cereal, and bars made with a mixture of novel corn fiber and a soluble fiber
Dietary supplement: Fiber made from corn starch + soluble fiber
25 g fiber as a fiber made from corn starch and a soluble fiber, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Satiety
Time Frame: 0, 15, 30, 45, 60, 90, 120, 180, 215 minutes postprandially
0, 15, 30, 45, 60, 90, 120, 180, 215 minutes postprandially

Secondary Outcome Measures

Outcome Measure
Time Frame
ad libitum food intake
Time Frame: 180 minutes postprandially and over 24 hours
180 minutes postprandially and over 24 hours
Ghrelin, polypeptide YY (PYY), and glucagon-like peptide-1 (GLP-1) response
Time Frame: 0, 30, 60 minutes postprandially
0, 30, 60 minutes postprandially
Gastrointestinal tolerance and fecal chemistry
Time Frame: following 7 days of treatment
following 7 days of treatment
Glucose/Insulin Response
Time Frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially
0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

Tate and Lyle Ingredients France

Investigators

  • Principal Investigator: Joanne L Slavin, PhD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

August 12, 2009

First Submitted That Met QC Criteria

August 12, 2009

First Posted (Estimate)

August 13, 2009

Study Record Updates

Last Update Posted (Estimate)

February 6, 2012

Last Update Submitted That Met QC Criteria

February 3, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0701M00264

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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