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
  Purpose

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.


Condition Intervention Phase
Healthy
Dietary Supplement: Short chain fructo-oligosaccharide (scFOS) 5 g
Other: Placebo
Dietary Supplement: Short chain fructooligosaccharide (scFOS) 8 g
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Satiety Response of Short Chain Fructooligosaccharide

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: March 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100788

Locations
United States, Minnesota
University of Minnesota
Saint Paul, Minnesota, United States, 55108
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Joanne Slavin University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: Joanne Slavin, University of Minnesota
ClinicalTrials.gov Identifier: NCT01100788     History of Changes
Other Study ID Numbers: 0806M37444
Study First Received: March 5, 2010
Last Updated: April 8, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 20, 2014