Healthy
Conditions
Keywords
Healthy adults
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.
Interventions
DIETARY_SUPPLEMENTGlucose polymer fiber
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
DIETARY_SUPPLEMENTFiber made from corn starch
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
DIETARY_SUPPLEMENTplacebo
low fiber breakfast cereal and muffin
Sponsors
Tate and Lyle Ingredients France
General Mills
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed