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Satiety, Glycemic, and Gastrointestinal Effects of Novel Fibers

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ClinicalTrials.gov Identifier: NCT00958399
Recruitment Status : Completed
First Posted : August 13, 2009
Last Update Posted : February 6, 2012
Sponsor:
Collaborator:
Tate and Lyle Ingredients France
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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.


Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Placebo Dietary Supplement: Resistant Starch Dietary Supplement: Resistant starch + soluble fiber Dietary Supplement: Fiber made from corn starch Dietary Supplement: Fiber made from corn starch + soluble fiber Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Satiety, Glycemic, and Gastrointestinal Effects of Novel Fibers
Study Start Date : July 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: No fiber
No fiber added to study products
Dietary Supplement: Placebo
Low fiber muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)
Experimental: Resistant Starch
Muffins, cereal, and bars made with a resistant starch
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)
Experimental: Resistant starch + soluble fiber
Muffins, cereal, and bars made with a mixture of resistant starch and a soluble fiber
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)
Experimental: Fiber made from corn starch
Muffins, cereal, and bars made with novel corn fiber
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)
Experimental: Fiber made from corn starch + soluble fiber
Muffins, cereal, and bars made with a mixture of novel corn fiber and a soluble fiber
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)



Primary Outcome Measures :
  1. Satiety [ Time Frame: 0, 15, 30, 45, 60, 90, 120, 180, 215 minutes postprandially ]

Secondary Outcome Measures :
  1. ad libitum food intake [ Time Frame: 180 minutes postprandially and over 24 hours ]
  2. Ghrelin, polypeptide YY (PYY), and glucagon-like peptide-1 (GLP-1) response [ Time Frame: 0, 30, 60 minutes postprandially ]
  3. Gastrointestinal tolerance and fecal chemistry [ Time Frame: following 7 days of treatment ]
  4. Glucose/Insulin Response [ Time Frame: 0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00958399


Locations
United States, Minnesota
University of Minnesota - General Clinical Research Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Tate and Lyle Ingredients France
Investigators
Principal Investigator: Joanne L Slavin, PhD University of Minnesota - Clinical and Translational Science Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00958399     History of Changes
Other Study ID Numbers: 0701M00264
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: February 6, 2012
Last Verified: February 2012

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
satiety
fiber
food intake
gut hormones
visual analog scales
microflora