Satiety Response After Mixed Fiber Doses | NCT00889993

Studies
Satiety Response After Mixed Fiber Doses

NCT00889993

Sponsor

University of Minnesota

Status

Completed

Last Update Posted

Mar 29, 2012Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Satiety

Interventions

Mixed Fiber Supplement

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 2012

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

Nov 2007

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Apr 27, 2009

First Submission Date that Met QC Criteria

Apr 28, 2009

First Posted Date

Apr 29, 2009Estimated

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 28, 2012

Last Update Posted Date

Mar 29, 2012Estimated

Name	Class
Société des Produits Nestlé (SPN)	INDUSTRY

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

People who eat more dietary fiber have a lower body weight than people who eat less fiber. Potential mechanisms include greater feelings of satiety, reductions in food intake, changes in blood glucose, insulin, or gut hormones.

The investigators hypothesize that increasing doses of mixed fiber will influence satiety response, food intake, glucose, insulin, ghrelin, GLP-1, and PYY 3-36, in a dose-dependent manner, when given to subjects in muffins for breakfast.

Detailed Description

Not provided

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

20Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mixed Fiber Supplement	Dietary Supplement	Breakfast Muffin containing 0g, 4g, 8g, and 12g of mixed fiber (total fiber amount as listed).

Measure	Description	Time Frame
Satiety and Food Intake		November 2007 thru May 2008

Measure	Description	Time Frame
Glucose, Insulin, Gut Hormone Response		November 2007 thru October 2008

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

English speaking
healthy men and women
18 and 65 years of age
non-smoking
not taking medications
non-dieting (weight stable over last 3 months)
BMI between 18 and 27
able to give blood through an IV

Exclusion Criteria:

irregular or erratic breakfast eating patterns
food allergies to ingredients commonly found in muffins or pizza
distaste for muffins or pizza
BMI less than 18 or greater than 27
weight change > 5 kg in last 3 months (intentional or unintentional)
cardiovascular disease
diabetes mellitus (fasting blood sugar > 126 mg/dl)
cancer in prior 5 years (except basal cell carcinoma of skin)
renal or hepatic disease
Crohns disease
ulcerative colitis
any other gastrointestinal conditions that may affect digestion or absorption
recent bacterial infection (< 3 months)
chronic medication use
history of drug or alcohol abuse in prior 6 months
concurrent or recent intervention study participation
vegetarians
people who ate more than approximately 15 g of fiber per day
pregnant or lactating women
women with irregular menstrual cycles

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota: General Clinical Research Center		Minneapolis	Minnesota	55455	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21310305	Derived	Willis HJ, Thomas W, Eldridge AL, Harkness L, Green H, Slavin JL. Glucose and insulin do not decrease in a dose-dependent manner after increasing doses of mixed fibers that are consumed in muffins for breakfast. Nutr Res. 2011 Jan;31(1):42-7. doi: 10.1016/j.nutres.2010.12.006.