NCT01560000

Brief Summary

The objective of this study is to determine the satiety value of different bran fibers on appetite \& subsequent food intake with acute consumption. Satiety will be measured subjectively by visual analogue scales (VAS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

March 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 21, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 15, 2013

Status Verified

March 1, 2013

Enrollment Period

9 months

First QC Date

March 5, 2012

Last Update Submit

March 13, 2013

Conditions

Food

Keywords

The focus of this study is to determine satiety

Outcome Measures

Primary Outcomes (1)

  • Satiety response

    4 hours

Study Arms (1)

fiber

OTHER
Dietary Supplement: Dietary fiber

Interventions

Dietary fiberDIETARY_SUPPLEMENT

Wheat, barley, oat and bran fibers added to a breakfast product

fiber

Eligibility Criteria

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

You may qualify if:

  • healthy women between the ages of 18-40
  • body mass index between 18.5-29.9kg/m2
  • eat breakfast regularly
  • nonsmoking
  • not taking weight loss medications
  • non-dieting (weight stable over the past 3 months)
  • spoken and written English literacy.

You may not qualify if:

  • antibiotic use within the past 6 months
  • cardiovascular disease
  • diabetes mellitus
  • cancer in the past 5 years
  • renal or hepatic disease
  • recent bacterial infection
  • gastrointestinal conditions affecting digestion or absorption
  • weight loss\>5kg in prior 3 months (intentional or unintentional)
  • history of drug or alcohol abuse in prior 6 months
  • food allergies
  • high fiber intake(3 or more servings of high fiber foods per day)
  • lipid-lowering, anti-hypertensive or anti-inflammatory steroid medication use
  • restrained eater(score\>10 on the dietary restraint factor of the Three Factor Eating Questionnaire)
  • concurrent or recent (within 30 days) participation in an intervention study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Saint Paul, Minnesota, 55108, United States

Location

Related Publications (1)

  • Korczak R, Lindeman K, Thomas W, Slavin JL. Bran fibers and satiety in women who do not exhibit restrained eating. Appetite. 2014 Sep;80:257-63. doi: 10.1016/j.appet.2014.05.025. Epub 2014 May 27.

    PMID: 24874565DERIVED

MeSH Terms

Interventions

Dietary Fiber

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Joanne Slavin, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2012

First Posted

March 21, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 15, 2013

Record last verified: 2013-03

Locations

US(1)