Satiety Response After Mixed Fiber Doses

This study has been completed.

Sponsor:

Collaborator:

Nestlé

Information provided by (Responsible Party):

University of Minnesota - Clinical and Translational Science Institute

ClinicalTrials.gov Identifier:

NCT00889993

First received: April 27, 2009

Last updated: March 28, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 27, 2009

Last Updated Date

March 28, 2012

Start Date ^ICMJE

November 2007

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Satiety and Food Intake [ Time Frame: November 2007 thru May 2008 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00889993 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Glucose, Insulin, Gut Hormone Response [ Time Frame: November 2007 thru October 2008 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Satiety Response After Mixed Fiber Doses

Official Title ^ICMJE

Effect of Four Doses of Mixed Fiber on Satiety, Food Intake, Glucose, Insulin, and Gut Hormone Release

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

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Condition ^ICMJE

Satiety

Intervention ^ICMJE

Dietary Supplement: Mixed Fiber Supplement

Breakfast Muffin containing 0g, 4g, 8g, and 12g of mixed fiber (total fiber amount as listed).

Study Arm (s)

Not Provided

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00889993

Other Study ID Numbers ^ICMJE

0701M00265

Has Data Monitoring Committee

Responsible Party

University of Minnesota - Clinical and Translational Science Institute

Study Sponsor ^ICMJE

University of Minnesota - Clinical and Translational Science Institute

Collaborators ^ICMJE

Nestlé

Investigators ^ICMJE

Principal Investigator:

Joanne L Slavin, PhD

University of Minnesota - Clinical and Translational Science Institute

Information Provided By

University of Minnesota - Clinical and Translational Science Institute

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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