Satiety Response After Mixed Fiber Doses

March 28, 2012 updated by: University of Minnesota

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

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.

Study Overview

Status

Completed

Conditions

Satiety

Intervention / Treatment

Dietary supplement: Mixed Fiber Supplement

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Minnesota
  - Minneapolis, Minnesota, United States, 55455
    - University of Minnesota: General Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

Nestlé

Investigators

Principal Investigator: Joanne L Slavin, PhD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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. doi: 10.1016/j.nutres.2010.12.006.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)