Satiety Response of Four Dietary Fibers

March 28, 2012 updated by: University of Minnesota

Satiety Response of Fructo-oligosaccharide (FOS), Inulin, Soluble Corn Fiber (SCF), and Resistant Starch (RS) in Overweight Woman and Relationship to Fermentation

Studies have found a relationship between dietary fiber consumption and body weight regulation. This relationship may stem from enhanced satiety through fermentation of certain fibers in the large intestine.

The objective of this study is to determine and compare satiety ratings, changes in food intake, and gastrointestinal effects for four fibers: fructooligosaccharide, inulin, soluble corn fiber, and resistant starch.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Early Phase 1

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
      • Saint Paul, Minnesota, United States, 55108
        • University of Minnesota

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

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy women
  • Age 18-40 years
  • Nonsmoking
  • Not taking weight loss medications
  • Non-dieting (weight has not changed more than 11 pounds over three months)
  • BMI between 18.5 and 29
  • Spoken and written English literacy

Exclusion Criteria:

  • Do not regularly consume breakfast
  • Food allergies to wheat, soy, peanut, or dairy
  • BMI less than 25 or greater than 29 upon admission to study
  • Cancer diagnosis in past 5 years
  • History of heart disease, kidney disease, diabetes, or eating disorder
  • History of ulcerative colitis, Crohn's disease, or any other gastrointestinal condition
  • History of drug or alcohol abuse in past 6 months
  • Use of lipid-lowering, anti-hypertensive, or anti-inflammatory steroid medication
  • Concurrent or recent (within 30 days) intervention study participation
  • Pregnant or lactating
  • Irregular menstrual cycle
  • Vegetarians
  • People who eat more than approximately 15 grams of fiber per day

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Low fiber control
no treatment dinner bar, no treatment breakfast bar
Dietary supplement: Control
Dinner bar fortified with 0g fiber; breakfast bar fortified with 0g dietary fiber.
Other Names:
  • Low fiber control
Experimental: Promitor soluble corn fiber
12g in dinner bar, 11g in breakfast bar
Dietary supplement: Soluble corn fiber
Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
Other Names:
  • Promitor soluble corn fiber
Experimental: FiberSym resistant starch
12g in dinner bar, 11g breakfast bar
Dietary supplement: Resistant starch
Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
Other Names:
  • FiberSym resistant starch
Experimental: Orafti P95 fructooligosaccharide
12g in dinner bar, 11g in breakfast bar
Dietary supplement: Fructooligosaccharide
Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
Other Names:
  • Orafti P95 fructooligosaccharide
Experimental: Orafti HPX inulin
12g in dinner bar, 11g in breakfast bar
Dietary supplement: Inulin
Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
Other Names:
  • Orafti HPX inulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satiety response using visual analogue scales
Time Frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially
Satiety response will be measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Food intake
Time Frame: 180 minutes postprandially and over 24 hours
180 minutes postprandially and over 24 hours
Breath hydrogen response
Time Frame: 0 and 180 minutes
0 and 180 minutes
Gastrointestinal tolerance using visual analogue scales (VAS)
Time Frame: 24 hours
Subjective ratings of bloating, stool consistency, and flatulence will be measured using VAS. A stool count will also be recorded.
24 hours

Collaborators and Investigators

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

Sponsor

University of Minnesota

Investigators

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

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

November 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

May 28, 2010

First Submitted That Met QC Criteria

November 1, 2010

First Posted (Estimate)

November 2, 2010

Study Record Updates

Last Update Posted (Estimate)

March 29, 2012

Last Update Submitted That Met QC Criteria

March 28, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1003E78714

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.

Clinical Trials on Healthy

Clinical Trials on Control

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe