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Completed

NCT Number: NCT01102881

Laxation and Satiety Response of Novel Dietary Fibers

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Saint Paul, Minnesota, 55108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucose polymer fiber

Dietary Supplement

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

Fiber made from corn starch

Dietary Supplement

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 names: Dietary fiber made from corn starch

Placebo

Dietary Supplement

low fiber breakfast cereal and muffin

Primary outcomes

  1. 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

  1. Satiety

    Time frame: 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes postprandially

    Measure hunger, fullness, satisfaction, and prospective food consumption using a 100 mm line

  2. Breath Hydrogen concentration after consumption of test cereal

    Time frame: 0 and 240 minutes postprandially

    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.

  3. Ad libitum food intake

    Time frame: 24 hours, 48 hours, and 10 days after the start of treatment

    24 hour food diary

  4. Gastrointestinal Tolerance

    Time frame: 24 hours, 48 hours, and 10 days after the start of the treatment

    Rank severity of flatuence, bloating, abdominal cramps, stomach noises, nausea, diarrhea, and constipation on a 10 point scale.

  5. Fecal chemistry

    Time frame: 6-10 days after the start of treatments

    Determination of fecal pH and short-chain fatty acid concentration

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • General Mills
  • Tate and Lyle Ingredients France

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 13, 2010
Registry last updated
Sep 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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