Satiety Response of Four Dietary Fibers
March 28, 2012 updated by: University of Minnesota
Satiety Response of Fructo-oligosaccharide (FOS), Inulin, Soluble Corn Fiber (SCF), and Resistant Starch (RS) in Overweight Woman and Relationship to Fermentation
Studies have found a relationship between dietary fiber consumption and body weight regulation. This relationship may stem from enhanced satiety through fermentation of certain fibers in the large intestine.
The objective of this study is to determine and compare satiety ratings, changes in food intake, and gastrointestinal effects for four fibers: fructooligosaccharide, inulin, soluble corn fiber, and resistant starch.
Study Overview
Status
Completed
Conditions
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
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Minnesota
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Saint Paul, Minnesota, United States, 55108
- University of Minnesota
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-
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
14 years to 36 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Healthy women
- Age 18-40 years
- Nonsmoking
- Not taking weight loss medications
- Non-dieting (weight has not changed more than 11 pounds over three months)
- BMI between 18.5 and 29
- Spoken and written English literacy
Exclusion Criteria:
- Do not regularly consume breakfast
- Food allergies to wheat, soy, peanut, or dairy
- BMI less than 25 or greater than 29 upon admission to study
- Cancer diagnosis in past 5 years
- History of heart disease, kidney disease, diabetes, or eating disorder
- History of ulcerative colitis, Crohn's disease, or any other gastrointestinal condition
- History of drug or alcohol abuse in past 6 months
- Use of lipid-lowering, anti-hypertensive, or anti-inflammatory steroid medication
- Concurrent or recent (within 30 days) intervention study participation
- Pregnant or lactating
- Irregular menstrual cycle
- Vegetarians
- People who eat more than approximately 15 grams of fiber per day
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 Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Low fiber control
no treatment dinner bar, no treatment breakfast bar
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Dinner bar fortified with 0g fiber; breakfast bar fortified with 0g dietary fiber.
Other Names:
|
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Experimental: Promitor soluble corn fiber
12g in dinner bar, 11g in breakfast bar
|
Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
Other Names:
|
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Experimental: FiberSym resistant starch
12g in dinner bar, 11g breakfast bar
|
Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
Other Names:
|
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Experimental: Orafti P95 fructooligosaccharide
12g in dinner bar, 11g in breakfast bar
|
Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
Other Names:
|
|
Experimental: Orafti HPX inulin
12g in dinner bar, 11g in breakfast bar
|
Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
Other Names:
|
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 minutes postprandially
|
Satiety response will be 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 minutes postprandially
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food intake
Time Frame: 180 minutes postprandially and over 24 hours
|
180 minutes postprandially and over 24 hours
|
|
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Breath hydrogen response
Time Frame: 0 and 180 minutes
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0 and 180 minutes
|
|
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Gastrointestinal tolerance using visual analogue scales (VAS)
Time Frame: 24 hours
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Subjective ratings of bloating, stool consistency, and flatulence will be measured using VAS.
A stool count will also be recorded.
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joanne L Slavin, PhD, 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
November 1, 2010
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
May 28, 2010
First Submitted That Met QC Criteria
November 1, 2010
First Posted (Estimate)
November 2, 2010
Study Record Updates
Last Update Posted (Estimate)
March 29, 2012
Last Update Submitted That Met QC Criteria
March 28, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1003E78714
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.