Satiety Response of Four Dietary Fibers

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University of Minnesota - Clinical and Translational Science Institute

ClinicalTrials.gov Identifier:

NCT01233024

First received: May 28, 2010

Last updated: March 28, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 28, 2010

Last Updated Date

March 28, 2012

Start Date ^ICMJE

November 2010

Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Satiety response using visual analogue scales [ Time Frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially ] [ Designated as safety issue: No ]

Satiety response will be measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).

Original Primary Outcome Measures ^ICMJE

Satiety response using visual analogue scales [ Time Frame: 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes postprandially ] [ Designated as safety issue: No ]

Satiety response will be measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).

Change History

Complete list of historical versions of study NCT01233024 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Food intake [ Time Frame: 180 minutes postprandially and over 24 hours ] [ Designated as safety issue: No ]
Breath hydrogen response [ Time Frame: 0 and 180 minutes ] [ Designated as safety issue: No ]
Gastrointestinal tolerance using visual analogue scales (VAS) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Subjective ratings of bloating, stool consistency, and flatulence will be measured using VAS. A stool count will also be recorded.

Original Secondary Outcome Measures ^ICMJE

Ad libitum food intake [ Time Frame: 240 minutes postprandially and over 24 hours ] [ Designated as safety issue: No ]
Breath hydrogen response [ Time Frame: 0, 120, and 240 minutes ] [ Designated as safety issue: No ]
Gastrointestinal tolerance using visual analogue scales (VAS) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Subjective ratings of bloating, stool consistency, and flatulence will be measured using VAS. A stool count will also be recorded.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Satiety Response of Four Dietary Fibers

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 0

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Dietary Supplement: Control
Dinner bar fortified with 0g fiber; breakfast bar fortified with 0g dietary fiber.

Other Name: Low fiber control
Dietary Supplement: Soluble corn fiber
Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.

Other Name: Promitor soluble corn fiber
Dietary Supplement: Resistant starch
Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.

Other Name: FiberSym resistant starch
Dietary Supplement: Fructooligosaccharide
Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.

Other Name: Orafti P95 fructooligosaccharide
Dietary Supplement: Inulin
Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.

Other Name: Orafti HPX inulin

Study Arm (s)

Placebo Comparator: Low fiber control
no treatment dinner bar, no treatment breakfast bar

Intervention: Dietary Supplement: Control
Experimental: Promitor soluble corn fiber
12g in dinner bar, 11g in breakfast bar

Intervention: Dietary Supplement: Soluble corn fiber
Experimental: FiberSym resistant starch
12g in dinner bar, 11g breakfast bar

Intervention: Dietary Supplement: Resistant starch
Experimental: Orafti P95 fructooligosaccharide
12g in dinner bar, 11g in breakfast bar

Intervention: Dietary Supplement: Fructooligosaccharide
Experimental: Orafti HPX inulin
12g in dinner bar, 11g in breakfast bar

Intervention: Dietary Supplement: Inulin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2012

Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01233024

Other Study ID Numbers ^ICMJE

1003E78714

Has Data Monitoring Committee

Responsible Party

University of Minnesota - Clinical and Translational Science Institute

Study Sponsor ^ICMJE

University of Minnesota - Clinical and Translational Science Institute

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Joanne L Slavin, PhD

University of Minnesota - Clinical and Translational Science Institute

Information Provided By

University of Minnesota - Clinical and Translational Science Institute

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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