Satiety Response of Short Chain Fructooligosaccharide
This study has been completed.
Sponsor:
University of Minnesota - Clinical and Translational Science Institute
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
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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
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 May 16, 2013