Laxation and Satiety Response of Novel Dietary Fibers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Laxation and Satiety Response of Novel Dietary Fibers

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Glucose polymer fiber
* Dietary Supplement: Fiber made from corn starch
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: No fiber<br>No fiber added to muffins or cereal | Dietary Supplement: placebo<br>* low fiber breakfast cereal and muffin<br>|
| Experimental: Fiber made from corn starch<br>Muffins and cereal made with novel corn fiber | Dietary Supplement: Fiber made from corn starch<br>* 20 grams of fiber per day split into two 10 gram doses administered as a breakfast cereal and a muffin or no-fiber breakfast cereal and muffin<br>* Other names: Dietary fiber made from corn starch;|
| Experimental: Glucose polymer fiber<br>Muffins and cereal made from glucose polymer fiber | Dietary Supplement: Glucose polymer fiber<br>* 20 grams of fiber per day split into two 10 gram doses administered as a breakfast cereal and a muffin or no-fiber breakfast cereal and muffin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole gut transit time determined by radio-opaque pellets | Determine whole gut transit time by x-raying fecal samples after swallowing radio-opaque pellets | 5 day fecal collection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satiety | Measure hunger, fullness, satisfaction, and prospective food consumption using a 100 mm line | 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes postprandially | 
| Breath Hydrogen concentration after consumption of test cereal | 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. | 0 and 240 minutes postprandially | 
| Ad libitum food intake | 24 hour food diary | 24 hours, 48 hours, and 10 days after the start of treatment | 
| Gastrointestinal Tolerance | Rank severity of flatuence, bloating, abdominal cramps, stomach noises, nausea, diarrhea, and constipation on a 10 point scale. | 24 hours, 48 hours, and 10 days after the start of the treatment | 
| Fecal chemistry | Determination of fecal pH and short-chain fatty acid concentration | 6-10 days after the start of treatments | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy adults