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Laxation and Satiety Response of Novel Dietary Fibers

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Completed

Conditions

Healthy

Treatments

Dietary Supplement: Glucose polymer fiber
Dietary Supplement: Fiber made from corn starch
Dietary Supplement: placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01102881
0902M60241

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

36 participants in 3 patient groups, including a placebo group

No fiber
Placebo Comparator group
Description:
No fiber added to muffins or cereal
Treatment:
Dietary Supplement: placebo
Fiber made from corn starch
Experimental group
Description:
Muffins and cereal made with novel corn fiber
Treatment:
Dietary Supplement: Fiber made from corn starch
Glucose polymer fiber
Experimental group
Description:
Muffins and cereal made from glucose polymer fiber
Treatment:
Dietary Supplement: Glucose polymer fiber

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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