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

March 5, 2010
April 8, 2010
March 2009
June 2009   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01100788 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Satiety Response of Short Chain Fructooligosaccharide
Satiety Response of Short Chain Fructooligosaccharide

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.

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

Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Healthy
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01100788
0806M37444
No
Joanne Slavin, University of Minnesota
University of Minnesota - Clinical and Translational Science Institute
Not Provided
Principal Investigator: Joanne Slavin University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
April 2010

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