Satiety, Glycemic, and Gastrointestinal Effects of Novel Fibers

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Resistant Starch; Dietary Supplement: Resistant starch + soluble fiber; Dietary Supplement: Fiber made from corn starch; Dietary Supplement: Fiber made from corn starch + soluble fiber

• Registration Number: NCT00958399
• Lead Sponsor: University of Minnesota

Brief Summary

Research suggests dietary fiber may play a role in weight management, and fiber consumption is inversely associated with body weight, body fat, and BMI in cross-sectional studies. These effects may be mediated by increased satiety, reduced food intake, or changes in blood levels of glucose, insulin, and gut hormones.

The purpose of this study is to determine the satiety, glycemic, hormonal, and gastrointestinal responses of novel fiber supplements.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2009-04
• Study First Submitted: 2009-08-12
• Study First Submitted QC: 2009-08-12
• Study First Posted: 2009-08-13
• Study Completion: 2010-04
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-03
• Last Update Posted: 2012-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• healthy men and women
• age 18-60 years
• non-smoking
• not taking medication
• non-dieting (weight stable in prior 3 months)
• BMI 18-27
• English literacy
• ability to give blood

Exclusion Criteria

• do not regularly consume breakfast
• food allergies to ingredients found in study products
• dislike for muffins, fiber bars, or hot cereal
• BMI <18 or >27
• diagnosed cardiovascular, renal, or hepatic disease
• diabetes mellitus (fasting blood sugar >126 mg/dl)
• cancer in previous 5 years (except basal cell carcinoma of the skin)
• any gastrointestinal disease or condition
• recent bacterial infection (< 3 months)
• recent or concurrent participation in an intervention research study
• history of drug or alcohol abuse in prior 6 months
• use of lipid-lowering, anti-hypertensive, or anti-inflammatory steroid medication
• restrained eaters
• vegetarians
• people who eat more than approximately 15 grams of fiber per day
• women who are pregnant or lactating
• women with irregular menstrual cycles

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
No fiber	Placebo	No fiber added to study products
Resistant Starch	Resistant Starch	Muffins, cereal, and bars made with a resistant starch
Resistant starch + soluble fiber	Resistant starch + soluble fiber	Muffins, cereal, and bars made with a mixture of resistant starch and a soluble fiber
Fiber made from corn starch	Fiber made from corn starch	Muffins, cereal, and bars made with novel corn fiber
Fiber made from corn starch + soluble fiber	Fiber made from corn starch + soluble fiber	Muffins, cereal, and bars made with a mixture of novel corn fiber and a soluble fiber

Primary Outcome Measures

Name	Time	Method
Satiety	0, 15, 30, 45, 60, 90, 120, 180, 215 minutes postprandially

Secondary Outcome Measures

Name	Time	Method
ad libitum food intake	180 minutes postprandially and over 24 hours
Ghrelin, polypeptide YY (PYY), and glucagon-like peptide-1 (GLP-1) response	0, 30, 60 minutes postprandially
Gastrointestinal tolerance and fecal chemistry	following 7 days of treatment
Glucose/Insulin Response	0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially

Trial Locations

Locations (1)

University of Minnesota - General Clinical Research Center; 🇺🇸 Minneapolis, Minnesota, United States