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| Name | Class |
|---|---|
| Tate and Lyle Ingredients France | INDUSTRY |
| General Mills | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No fiber | Placebo Comparator | No fiber added to muffins or cereal |
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| Fiber made from corn starch | Experimental | Muffins and cereal made with novel corn fiber |
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| Glucose polymer fiber | Experimental | Muffins and cereal made from glucose polymer fiber |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucose polymer fiber | Dietary Supplement | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne L Slavin, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Saint Paul | Minnesota | 55108 | United States |
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| Fiber made from corn starch | Dietary Supplement | 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 |
|
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| placebo | Dietary Supplement | low fiber breakfast cereal and muffin |
|
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 |