Laxation and Satiety Response of Novel Dietary Fibers

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: placebo; Dietary Supplement: Fiber made from corn starch; Dietary Supplement: Glucose polymer fiber

• Registration Number: NCT01102881
• Lead Sponsor: University of Minnesota

Brief Summary

Dietary fibers have previously been shown to affect laxation and satiety. Due to differences in structure and physical properties of dietary fibers, these effects may not be consistent across all fibers. Therefore as new dietary fibers are created or discovered the laxative and satiating effects should be investigated in order to verify these effects.

Detailed Description

This study was designed to test the laxative effects of two fibers a resistant starch made from corn and a glucose polymer fiber. The secondary aim of this study was to examine the satieting effects of these fibers. This trial was double-blind and placebo controlled. On the first day of the study subjects consumed the breakfast cereal and milk and were instructed to complete visual analog scales periodically to test acute satiety. Subjects also completed diet records and tolerance questionnaires on days 1,2, and 10. Additionally subjects completed another satiety survey on day 10 to test chronic satiety. Whole gut transit time, fecal weight, and fecal chemistry was tested by swallowing radioopaque pellets on day 6 and collecting every fecal sample for the 5 days thereafter.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-03-23
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Study First Submitted QC: 2010-04-12
• Study First Posted: 2010-04-13
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-08
• Last Update Posted: 2010-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• healthy men and women
• age 18-65
• non-smoking
• not taking medication
• non-dieting (weight stable in prior 3 months)
• BMI 18-30
• English literacy

Exclusion Criteria

• do not regularly consume breakfast
• food allergies to ingredients found in study product
• dislike of cereal or muffins
• BMI <18 or >30
• diagnosed with cardiovascular, renal, or hepatic disease
• diabetes mellitus (fasting blood glucose > 126 mg/ml)
• 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 medications vegetarians people who eat more than approximately 15 grams of dietary fiber per day women who are pregnant or lactating women with irregular menstrual cycles consumption of prebiotics or probiotics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
No fiber	placebo	No fiber added to muffins or cereal
Fiber made from corn starch	Fiber made from corn starch	Muffins and cereal made with novel corn fiber
Glucose polymer fiber	Glucose polymer fiber	Muffins and cereal made from glucose polymer fiber

Primary Outcome Measures

Name	Time	Method
Whole gut transit time determined by radio-opaque pellets	5 day fecal collection	Determine whole gut transit time by x-raying fecal samples after swallowing radio-opaque pellets

Secondary Outcome Measures

Name	Time	Method
Satiety	0, 15, 30, 45, 60, 90, 120, 180, 240 minutes postprandially	Measure hunger, fullness, satisfaction, and prospective food consumption using a 100 mm line
Breath Hydrogen concentration after consumption of test cereal	0 and 240 minutes postprandially	Subjects expel air into a storage bag, which is then injected into a gas chromatograph and determine the hydrogen concentration. Hydrogen gas is an indicator of fermentation in the large intestine.
Ad libitum food intake	24 hours, 48 hours, and 10 days after the start of treatment	24 hour food diary
Gastrointestinal Tolerance	24 hours, 48 hours, and 10 days after the start of the treatment	Rank severity of flatuence, bloating, abdominal cramps, stomach noises, nausea, diarrhea, and constipation on a 10 point scale.
Fecal chemistry	6-10 days after the start of treatments	Determination of fecal pH and short-chain fatty acid concentration

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 St. Paul, Minnesota, United States