Laxation and Satiety Response of Novel Dietary Fibers

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01102881
• Date of registration: 23/03/2010
• Primary sponsor: University of Minnesota - Clinical and Translational Science Institute
• Public title: Laxation and Satiety Response of Novel Dietary Fibers
• Scientific title: Laxation and Satiety Response of Novel Dietary Fibers
• Date of first enrolment: August 2009
• Target sample size: 36
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01102881
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Countries of recruitment

United States

Contacts

• Name: Joanne L Slavin, PhD
• Affiliation: University of Minnesota - Clinical and Translational Science Institute

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Dietary Supplement: Fiber made from corn starch

Dietary Supplement: Glucose polymer fiber

Dietary Supplement: placebo

Primary Outcome(s)

Whole gut transit time determined by radio-opaque pellets [Time Frame: 5 day fecal collection]

Secondary Outcome(s)

Ad libitum food intake [Time Frame: 24 hours, 48 hours, and 10 days after the start of treatment]

Breath Hydrogen concentration after consumption of test cereal [Time Frame: 0 and 240 minutes postprandially]

Fecal chemistry [Time Frame: 6-10 days after the start of treatments]

Gastrointestinal Tolerance [Time Frame: 24 hours, 48 hours, and 10 days after the start of the treatment]

Satiety [Time Frame: 0, 15, 30, 45, 60, 90, 120, 180, 240 minutes postprandially]

Secondary ID(s)

0902M60241

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

General Mills Inc.

Tate and Lyle Ingredients France