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Satiety Response of Four Dietary Fibers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01233024
First received: May 28, 2010
Last updated: March 28, 2012
Last verified: March 2012

May 28, 2010
March 28, 2012
November 2010
February 2012   (final data collection date for primary outcome measure)
Satiety response using visual analogue scales [ Time Frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially ] [ Designated as safety issue: No ]
Satiety response will be measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
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 will be measured using subjective perceptions of hunger, fullness, satisfaction, and prospective food intake evaluated by previously validated visual analogue scales (VAS).
Complete list of historical versions of study NCT01233024 on ClinicalTrials.gov Archive Site
  • Food intake [ Time Frame: 180 minutes postprandially and over 24 hours ] [ Designated as safety issue: No ]
  • Breath hydrogen response [ Time Frame: 0 and 180 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 will be measured using VAS. A stool count will also be recorded.
  • Ad libitum food intake [ Time Frame: 240 minutes postprandially and over 24 hours ] [ Designated as safety issue: No ]
  • Breath hydrogen response [ Time Frame: 0, 120, and 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 will be measured using VAS. A stool count will also be recorded.
Not Provided
Not Provided
 
Satiety Response of Four Dietary Fibers
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.

Not Provided
Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Healthy
  • Dietary Supplement: Control
    Dinner bar fortified with 0g fiber; breakfast bar fortified with 0g dietary fiber.
    Other Name: Low fiber control
  • Dietary Supplement: Soluble corn fiber
    Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
    Other Name: Promitor soluble corn fiber
  • Dietary Supplement: Resistant starch
    Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
    Other Name: FiberSym resistant starch
  • Dietary Supplement: Fructooligosaccharide
    Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
    Other Name: Orafti P95 fructooligosaccharide
  • Dietary Supplement: Inulin
    Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
    Other Name: Orafti HPX inulin
  • Placebo Comparator: Low fiber control
    no treatment dinner bar, no treatment breakfast bar
    Intervention: Dietary Supplement: Control
  • Experimental: Promitor soluble corn fiber
    12g in dinner bar, 11g in breakfast bar
    Intervention: Dietary Supplement: Soluble corn fiber
  • Experimental: FiberSym resistant starch
    12g in dinner bar, 11g breakfast bar
    Intervention: Dietary Supplement: Resistant starch
  • Experimental: Orafti P95 fructooligosaccharide
    12g in dinner bar, 11g in breakfast bar
    Intervention: Dietary Supplement: Fructooligosaccharide
  • Experimental: Orafti HPX inulin
    12g in dinner bar, 11g in breakfast bar
    Intervention: Dietary Supplement: Inulin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01233024
1003E78714
No
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Not Provided
Principal Investigator: Joanne L Slavin, PhD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
March 2012

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