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OpenTrials
Completed

NCT Number: NCT01233024

Satiety Response of Four Dietary Fibers

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Minnesota

Saint Paul, Minnesota, 55108, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Dietary Supplement

Dinner bar fortified with 0g fiber; breakfast bar fortified with 0g dietary fiber.

Other names: Low fiber control

Soluble corn fiber

Dietary Supplement

Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.

Other names: Promitor soluble corn fiber

Resistant starch

Dietary Supplement

Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.

Other names: FiberSym resistant starch

Fructooligosaccharide

Dietary Supplement

Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.

Other names: Orafti P95 fructooligosaccharide

Inulin

Dietary Supplement

Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.

Other names: Orafti HPX inulin

Primary outcomes

  1. 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).

Secondary outcomes

  1. Food intake

    Time frame: 180 minutes postprandially and over 24 hours

  2. Breath hydrogen response

    Time frame: 0 and 180 minutes

  3. Gastrointestinal tolerance using visual analogue scales (VAS)

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Satiety Response of Fructo-oligosaccharide (FOS), Inulin, Soluble Corn Fiber (SCF), and Resistant Starch (RS) in Overweight Woman and Relationship to Fermentation

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 2, 2010
Registry last updated
Mar 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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