Clinical trial NCT00958399: Satiety, Glycemic, and Gastrointestinal Effects of Novel Fibers
Official title: Satiety, Glycemic, and Gastrointestinal Effects of Novel Fibers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: satiety
fiber
food intake
gut hormones
visual analog scales
microflora
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Tate and Lyle Ingredients France
First posted: 2009-08-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Research suggests dietary fiber may play a role in weight management, and fiber consumption is inversely associated with body weight, body fat, and BMI in cross-sectional studies. These effects may be mediated by increased satiety, reduced food intake, or changes in blood levels of glucose, insulin, and gut hormones.

The purpose of this study is to determine the satiety, glycemic, hormonal, and gastrointestinal responses of novel fiber supplements.


Eligibility criteria: Inclusion Criteria:

* healthy men and women
* age 18-60 years
* non-smoking
* not taking medication
* non-dieting (weight stable in prior 3 months)
* BMI 18-27
* English literacy
* ability to give blood

Exclusion Criteria:

* do not regularly consume breakfast
* food allergies to ingredients found in study products
* dislike for muffins, fiber bars, or hot cereal
* BMI \<18 or \>27
* diagnosed cardiovascular, renal, or hepatic disease
* diabetes mellitus (fasting blood sugar \>126 mg/dl)
* 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 medication
* restrained eaters
* vegetarians
* people who eat more than approximately 15 grams of fiber per day
* women who are pregnant or lactating
* women with irregular menstrual cycles

Primary outcomes:
measure: Satiety
timeFrame: 0, 15, 30, 45, 60, 90, 120, 180, 215 minutes postprandially
Secondary outcomes:
measure: ad libitum food intake
timeFrame: 180 minutes postprandially and over 24 hours
measure: Ghrelin, polypeptide YY (PYY), and glucagon-like peptide-1 (GLP-1) response
timeFrame: 0, 30, 60 minutes postprandially
measure: Gastrointestinal tolerance and fecal chemistry
timeFrame: following 7 days of treatment
measure: Glucose/Insulin Response
timeFrame: 0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota - General Clinical Research Center
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Joanne L Slavin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Timm DA, Thomas W, Boileau TW, Williamson-Hughes PS, Slavin JL. Polydextrose and soluble corn fiber increase five-day fecal wet weight in healthy men and women. J Nutr. 2013 Apr;143(4):473-8. doi: 10.3945/jn.112.170118. Epub 2013 Feb 20.