Satiety Response of Short Chain Fructooligosaccharide

April 8, 2010 updated by: University of Minnesota

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

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

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
No treatment
Other: Placebo
Treatment without scFOS fiber
EXPERIMENTAL: scFOS 5 g
5 g scFOS
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 Names:
  • fructo-oligosaccharide
EXPERIMENTAL: scFOS 8 g
8 g scFOS
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.

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, 240 minutes postprandially
Satiety response was 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, 240 minutes postprandially

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ad libitum food intake
Time Frame: 240 minutes postprandially and over 24 hours
240 minutes postprandially and over 24 hours
Breath hydrogen response
Time Frame: 0, 240 minutes
0, 240 minutes
Gastrointestinal tolerance using visual analogue scales (VAS)
Time Frame: 24 hours
Subjective ratings of bloating, stool consistency, and flatulence on VAS. A stool count was also recorded.
24 hours

Collaborators and Investigators

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

Sponsor

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

March 1, 2009

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

March 5, 2010

First Submitted That Met QC Criteria

April 8, 2010

First Posted (ESTIMATE)

April 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 9, 2010

Last Update Submitted That Met QC Criteria

April 8, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • 0806M37444

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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