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Satiety Response of Four Dietary Fibers

Sponsor
University of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT01233024
Collaborator
(none)
20
Enrollment
1
Location
5
Arms
15
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Control
  • Dietary Supplement: Soluble corn fiber
  • Dietary Supplement: Resistant starch
  • Dietary Supplement: Fructooligosaccharide
  • Dietary Supplement: Inulin
 Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Satiety Response of Fructo-oligosaccharide (FOS), Inulin, Soluble Corn Fiber (SCF), and Resistant Starch (RS) in Overweight Woman and Relationship to Fermentation
Study Start Date :
Nov 1, 2010
Actual Primary Completion Date :
Feb 1, 2012
Actual Study Completion Date :
Feb 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Low fiber control

no treatment dinner bar, no treatment breakfast bar

Dietary Supplement: Control
Dinner bar fortified with 0g fiber; breakfast bar fortified with 0g dietary fiber.
Other Names:
  • Low fiber control

    		•
    Experimental: Promitor soluble corn fiber

    12g in dinner bar, 11g in breakfast bar

    Dietary Supplement: Soluble corn fiber
    Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
    Other Names:
  • Promitor soluble corn fiber

    		•
    Experimental: FiberSym resistant starch

    12g in dinner bar, 11g breakfast bar

    Dietary Supplement: Resistant starch
    Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
    Other Names:
  • FiberSym resistant starch

    		•
    Experimental: Orafti P95 fructooligosaccharide

    12g in dinner bar, 11g in breakfast bar

    Dietary Supplement: Fructooligosaccharide
    Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
    Other Names:
  • Orafti P95 fructooligosaccharide

    		•
    Experimental: Orafti HPX inulin

    12g in dinner bar, 11g in breakfast bar

    Dietary Supplement: Inulin
    Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
    Other Names:
  • Orafti HPX inulin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Satiety response using visual analogue scales [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).

    Secondary Outcome Measures

    1. Food intake [180 minutes postprandially and over 24 hours]

    2. Breath hydrogen response [0 and 180 minutes]

    3. Gastrointestinal tolerance using visual analogue scales (VAS) [24 hours]

      Subjective ratings of bloating, stool consistency, and flatulence will be measured using VAS. A stool count will also be recorded.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Minnesota Saint Paul Minnesota United States 55108

    Sponsors and Collaborators

    • University of Minnesota

    Investigators

    • Principal Investigator: Joanne L Slavin, PhD, University of Minnesota

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT01233024
    Other Study ID Numbers:
    • 1003E78714
    First Posted:
    Nov 2, 2010
    Last Update Posted:
    Mar 29, 2012
    Last Verified:
    Mar 1, 2012
    Keywords provided by University of Minnesota
    Adult
    Women
    Dietary Fiber
    Satiety Response
    Food Intake

    Study Results

    No Results Posted as of Mar 29, 2012