Laxation and Satiety Response of Novel Dietary Fibers
This study has been completed.
Sponsor:
University of Minnesota - Clinical and Translational Science Institute
Collaborators:
Tate and Lyle Ingredients France
General Mills Inc.
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01102881
First received: March 23, 2010
Last updated: September 8, 2010
Last verified: September 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Healthy |
Dietary Supplement: Glucose polymer fiber Dietary Supplement: Fiber made from corn starch Dietary Supplement: placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | Laxation and Satiety Response of Novel Dietary Fibers |
Resource links provided by NLM:
MedlinePlus related topics:
Dietary Fiber
Drug Information available for:
Dextrose
U.S. FDA Resources
Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:
Primary Outcome Measures:
- Whole gut transit time determined by radio-opaque pellets [ Time Frame: 5 day fecal collection ] [ Designated as safety issue: No ]Determine whole gut transit time by x-raying fecal samples after swallowing radio-opaque pellets
Secondary Outcome Measures:
- Satiety [ Time Frame: 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes postprandially ] [ Designated as safety issue: No ]Measure hunger, fullness, satisfaction, and prospective food consumption using a 100 mm line
- Breath Hydrogen concentration after consumption of test cereal [ Time Frame: 0 and 240 minutes postprandially ] [ Designated as safety issue: No ]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 [ Time Frame: 24 hours, 48 hours, and 10 days after the start of treatment ] [ Designated as safety issue: No ]24 hour food diary
- Gastrointestinal Tolerance [ Time Frame: 24 hours, 48 hours, and 10 days after the start of the treatment ] [ Designated as safety issue: No ]Rank severity of flatuence, bloating, abdominal cramps, stomach noises, nausea, diarrhea, and constipation on a 10 point scale.
- Fecal chemistry [ Time Frame: 6-10 days after the start of treatments ] [ Designated as safety issue: No ]Determination of fecal pH and short-chain fatty acid concentration
| Enrollment: | 36 |
| Study Start Date: | August 2009 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: No fiber
No fiber added to muffins or cereal
|
Dietary Supplement: placebo
low fiber breakfast cereal and muffin
|
|
Experimental: Fiber made from corn starch
Muffins and cereal made with novel corn fiber
|
Dietary Supplement: Fiber 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
Other Name: Dietary fiber made from corn starch
|
|
Experimental: Glucose polymer fiber
Muffins and cereal made from glucose polymer fiber
|
Dietary Supplement: Glucose 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
Other Name: Glucose polymer fiber
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01102881
Locations
| United States, Minnesota | |
| University of Minnesota | |
| St. Paul, Minnesota, United States, 55108 | |
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Tate and Lyle Ingredients France
General Mills Inc.
Investigators
| Principal Investigator: | Joanne L Slavin, PhD | University of Minnesota - Clinical and Translational Science Institute |
More Information
No publications provided
| Responsible Party: | Joanne Slavin, University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT01102881 History of Changes |
| Other Study ID Numbers: | 0902M60241 |
| Study First Received: | March 23, 2010 |
| Last Updated: | September 8, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
|
Healthy adults |
ClinicalTrials.gov processed this record on May 22, 2013