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
  Purpose

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 Intervention Phase
Healthy
Dietary Supplement: Control
Dietary Supplement: Soluble corn fiber
Dietary Supplement: Resistant starch
Dietary Supplement: Fructooligosaccharide
Dietary Supplement: Inulin
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

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 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: November 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Orafti HPX inulin

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233024

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 L Slavin, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01233024     History of Changes
Other Study ID Numbers: 1003E78714
Study First Received: May 28, 2010
Last Updated: March 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Adult
Women
Dietary Fiber
Satiety Response
Food Intake

ClinicalTrials.gov processed this record on April 23, 2014