Effect of Bran Fiber Type on Subjective and Objective Mea... | NCT01560000

Studies
Effect of Bran Fiber Type on Subjective and Objective Measures of Appetite

NCT01560000

Sponsor

University of Minnesota

Status

Completed

Last Update Posted

Mar 15, 2013Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Food

Interventions

Dietary fiber

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Mar 5, 2012

First Submission Date that Met QC Criteria

Mar 20, 2012

First Posted Date

Mar 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2013

Last Update Posted Date

Mar 15, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Visual analogue scales will be used to measure satiety at 15, 30 45, 60, 120, 180, and 240 minutes

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
fiber	Other		Dietary Supplement: Dietary fiber

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dietary fiber	Dietary Supplement	Wheat, barley, oat and bran fibers added to a breakfast product	fiber

Measure	Description	Time Frame
Satiety response		4 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joanne Slavin, PhD	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota		Saint Paul	Minnesota	55108	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24874565	Derived	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.

ID	Term
D004040	Dietary Carbohydrates
D002241	Carbohydrates
D005502	Food
D000066888	Diet, Food, and Nutrition