NCT01233024

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1 healthy

Timeline
Completed

Started Nov 2010

Typical duration for early_phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

March 29, 2012

Status Verified

March 1, 2012

Enrollment Period

1.3 years

First QC Date

May 28, 2010

Last Update Submit

March 28, 2012

Conditions

Healthy

Keywords

AdultWomenDietary FiberSatiety ResponseFood Intake

Outcome Measures

Primary Outcomes (1)

  • Satiety response using visual analogue scales

    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 Outcomes (3)

  • Food intake

    180 minutes postprandially and over 24 hours

  • Breath hydrogen response

    0 and 180 minutes

  • Gastrointestinal tolerance using visual analogue scales (VAS)

    24 hours

Study Arms (5)

Low fiber control

PLACEBO COMPARATOR

no treatment dinner bar, no treatment breakfast bar

Dietary Supplement: Control

Promitor soluble corn fiber

EXPERIMENTAL

12g in dinner bar, 11g in breakfast bar

Dietary Supplement: Soluble corn fiber

FiberSym resistant starch

EXPERIMENTAL

12g in dinner bar, 11g breakfast bar

Dietary Supplement: Resistant starch

Orafti P95 fructooligosaccharide

EXPERIMENTAL

12g in dinner bar, 11g in breakfast bar

Dietary Supplement: Fructooligosaccharide

Orafti HPX inulin

EXPERIMENTAL

12g in dinner bar, 11g in breakfast bar

Dietary Supplement: Inulin

Interventions

ControlDIETARY_SUPPLEMENT

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

Also known as: Low fiber control
Low fiber control
Soluble corn fiberDIETARY_SUPPLEMENT

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

Also known as: Promitor soluble corn fiber
Promitor soluble corn fiber
Resistant starchDIETARY_SUPPLEMENT

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

Also known as: FiberSym resistant starch
FiberSym resistant starch
FructooligosaccharideDIETARY_SUPPLEMENT

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

Also known as: Orafti P95 fructooligosaccharide
Orafti P95 fructooligosaccharide
InulinDIETARY_SUPPLEMENT

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

Also known as: Orafti HPX inulin
Orafti HPX inulin

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Saint Paul, Minnesota, 55108, United States

Location

MeSH Terms

Interventions

Resistant StarchfructooligosaccharideInulin

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary FiberDietary CarbohydratesCarbohydratesPolysaccharidesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesFructans

Study Officials

  • Joanne L Slavin, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2010

First Posted

November 2, 2010

Study Start

November 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

March 29, 2012

Record last verified: 2012-03

Locations

US(1)