Laxation and Satiety Response of Novel Dietary Fibers

This study has been completed.
Sponsor:
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
  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:


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 April 23, 2014