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Satiety, Glycemic, and Gastrointestinal Effects of Novel Fibers

This study has been completed.
Sponsor:
Collaborator:
Tate and Lyle Ingredients France
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00958399
First received: August 12, 2009
Last updated: February 3, 2012
Last verified: February 2012
History of Changes

August 12, 2009
February 3, 2012
July 2008
April 2009   (final data collection date for primary outcome measure)
Satiety [ Time Frame: 0, 15, 30, 45, 60, 90, 120, 180, 215 minutes postprandially ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00958399 on ClinicalTrials.gov Archive Site
  • ad libitum food intake [ Time Frame: 180 minutes postprandially and over 24 hours ] [ Designated as safety issue: No ]
  • Ghrelin, polypeptide YY (PYY), and glucagon-like peptide-1 (GLP-1) response [ Time Frame: 0, 30, 60 minutes postprandially ] [ Designated as safety issue: No ]
  • Gastrointestinal tolerance and fecal chemistry [ Time Frame: following 7 days of treatment ] [ Designated as safety issue: No ]
  • Glucose/Insulin Response [ Time Frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Satiety, Glycemic, and Gastrointestinal Effects of Novel Fibers
Satiety, Glycemic, and Gastrointestinal Effects of Novel Fibers

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Healthy
  • Dietary Supplement: Placebo
    Low fiber muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)
  • Dietary Supplement: Resistant Starch
    25 g resistant starch, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)
  • Dietary Supplement: Resistant starch + soluble fiber
    25 g fiber as resistant starch and a soluble fiber, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)
  • Dietary Supplement: Fiber made from corn starch
    25 g fiber made from corn starch, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)
  • Dietary Supplement: Fiber made from corn starch + soluble fiber
    25 g fiber as a fiber made from corn starch and a soluble fiber, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)
  • Placebo Comparator: No fiber
    No fiber added to study products
    Intervention: Dietary Supplement: Placebo
  • Experimental: Resistant Starch
    Muffins, cereal, and bars made with a resistant starch
    Intervention: Dietary Supplement: Resistant Starch
  • Experimental: Resistant starch + soluble fiber
    Muffins, cereal, and bars made with a mixture of resistant starch and a soluble fiber
    Intervention: Dietary Supplement: Resistant starch + soluble fiber
  • Experimental: Fiber made from corn starch
    Muffins, cereal, and bars made with novel corn fiber
    Intervention: Dietary Supplement: Fiber made from corn starch
  • Experimental: Fiber made from corn starch + soluble fiber
    Muffins, cereal, and bars made with a mixture of novel corn fiber and a soluble fiber
    Intervention: Dietary Supplement: Fiber made from corn starch + soluble fiber
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2010
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00958399
0701M00264
No
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Tate and Lyle Ingredients France
Principal Investigator: Joanne L Slavin, PhD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP