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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: Fiber made from corn starch; Dietary supplement: 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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • St. Paul, Minnesota, United States, 55108
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole gut transit time determined by radio-opaque pellets	Determine whole gut transit time by x-raying fecal samples after swallowing radio-opaque pellets	5 day fecal collection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satiety	Measure hunger, fullness, satisfaction, and prospective food consumption using a 100 mm line	0, 15, 30, 45, 60, 90, 120, 180, 240 minutes postprandially
Breath Hydrogen concentration after consumption of test cereal	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.	0 and 240 minutes postprandially
Ad libitum food intake	24 hour food diary	24 hours, 48 hours, and 10 days after the start of treatment
Gastrointestinal Tolerance	Rank severity of flatuence, bloating, abdominal cramps, stomach noises, nausea, diarrhea, and constipation on a 10 point scale.	24 hours, 48 hours, and 10 days after the start of the treatment
Fecal chemistry	Determination of fecal pH and short-chain fatty acid concentration	6-10 days after the start of treatments

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: General Mills; Tate and Lyle Ingredients France
• Investigators: Principal Investigator: Joanne L Slavin, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: March 23, 2010
• First Submitted That Met QC Criteria: April 12, 2010
• First Posted (Estimate): April 13, 2010

Study Record Updates

• Last Update Posted (Estimate): September 9, 2010
• Last Update Submitted That Met QC Criteria: September 8, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Healthy adults
• Other Study ID Numbers: 0902M60241