Satiety Response of Short Chain Fructooligosaccharide

This study has been completed.

Sponsor:

Information provided by:

University of Minnesota - Clinical and Translational Science Institute

ClinicalTrials.gov Identifier:

NCT01100788

First received: March 5, 2010

Last updated: April 8, 2010

Last verified: April 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

March 5, 2010

Last Updated Date

April 8, 2010

Start Date ^ICMJE

March 2009

Primary Completion Date

June 2009 (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, 240 minutes postprandially ] [ Designated as safety issue: No ]

Satiety response was 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

Same as current

Change History

Complete list of historical versions of study NCT01100788 on ClinicalTrials.gov Archive Site

Current 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, 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 on VAS. A stool count was also recorded.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Satiety Response of Short Chain Fructooligosaccharide

Official Title ^ICMJE

Satiety Response of Short Chain Fructooligosaccharide

Brief Summary

Populations that report high fiber consumption demonstrate lower rates of obesity. Enhanced satiety may play a key role in this relationship. The colonic fermentation of fibers is theorized to influence satiety and food intake. Short chain fructooligosaccharide (scFOS) are rapidly fermentable fibers that can easily be added to foods to impact these parameters.

The objective of this study was to evaluate the satiety response of scFOS and its ability to decrease food intake.

Detailed Description

Intervention study with fiber added to beverages and acute effects on satiety measured.

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)
Primary Purpose: Prevention

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Dietary Supplement: Short chain fructo-oligosaccharide (scFOS) 5 g
Dietary Supplement: scFOS 5 g

Novel fiber administered in two 5 g doses--the first in a beverage and the second in a solid chew.

Other Name: fructo-oligosaccharide
Other: Placebo
Treatment without scFOS fiber
Dietary Supplement: Short chain fructooligosaccharide (scFOS) 8 g
Novel fiber administered in two 8 g doses--the first in a beverage and the second in a solid chew.

Study Arm (s)

Placebo Comparator: Placebo
No treatment

Intervention: Other: Placebo
Experimental: scFOS 5 g
5 g scFOS

Intervention: Dietary Supplement: Short chain fructo-oligosaccharide (scFOS) 5 g
Experimental: scFOS 8 g
8 g scFOS

Intervention: Dietary Supplement: Short chain fructooligosaccharide (scFOS) 8 g

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

June 2009

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy men and women
Age 18-64 years
Non-smoking
Not taking medication
Non-dieting (weight stable in prior 3 months)
BMI 18-27
English literacy

Exclusion Criteria:

Do not regularly consume breakfast
Food allergies to ingredients found in study products
BMI <18 or >27
Diagnosed cardiovascular, renal, or hepatic disease diabetes mellitus
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
Eating disorder
Vegetarians
People who eat more than approximately 15 grams of fiber per day
Women who are pregnant or lactating
Women with irregular menstrual cycles

Gender

Both

Ages

18 Years to 64 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

NCT01100788

Other Study ID Numbers ^ICMJE

0806M37444

Has Data Monitoring Committee

Responsible Party

Joanne Slavin, University of Minnesota

Study Sponsor ^ICMJE

University of Minnesota - Clinical and Translational Science Institute

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Joanne Slavin

University of Minnesota - Clinical and Translational Science Institute

Information Provided By

University of Minnesota - Clinical and Translational Science Institute

Verification Date

April 2010

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

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