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Clinical Trials/NCT01102881
NCT01102881
Completed
Not Applicable

Laxation and Satiety Response of Novel Dietary Fibers

University of Minnesota1 site in 1 country36 target enrollmentAugust 2009
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
University of Minnesota
Enrollment
36
Locations
1
Primary Endpoint
Whole gut transit time determined by radio-opaque pellets
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2009
End Date
April 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

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

Outcomes

Primary Outcomes

Whole gut transit time determined by radio-opaque pellets

Time Frame: 5 day fecal collection

Determine whole gut transit time by x-raying fecal samples after swallowing radio-opaque pellets

Secondary Outcomes

  • Satiety(0, 15, 30, 45, 60, 90, 120, 180, 240 minutes postprandially)
  • Breath Hydrogen concentration after consumption of test cereal(0 and 240 minutes postprandially)
  • Ad libitum food intake(24 hours, 48 hours, and 10 days after the start of treatment)
  • Gastrointestinal Tolerance(24 hours, 48 hours, and 10 days after the start of the treatment)
  • Fecal chemistry(6-10 days after the start of treatments)

Study Sites (1)

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