Clinical trial NCT01102881: Laxation and Satiety Response of Novel Dietary Fibers
Official title: Laxation and Satiety Response of Novel Dietary Fibers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Healthy adults
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Tate and Lyle Ingredients France
name: General Mills
First posted: 2010-04-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Whole gut transit time determined by radio-opaque pellets
timeFrame: 5 day fecal collection
Secondary outcomes:
measure: Satiety
timeFrame: 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes postprandially
measure: Breath Hydrogen concentration after consumption of test cereal
timeFrame: 0 and 240 minutes postprandially
measure: Ad libitum food intake
timeFrame: 24 hours, 48 hours, and 10 days after the start of treatment
measure: Gastrointestinal Tolerance
timeFrame: 24 hours, 48 hours, and 10 days after the start of the treatment
measure: Fecal chemistry
timeFrame: 6-10 days after the start of treatments
Other outcomes:
Locations:
city: St. Paul
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Joanne L Slavin, PhD
role: PRINCIPAL_INVESTIGATOR
References: