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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
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Satiety, Glycemic, and Gastrointestinal Effects of Novel Fibers

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Satiety [ Time Frame: 0, 15, 30, 45, 60, 90, 120, 180, 215 minutes postprandially ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: July 2008
Study Completion Date: April 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by University of Minnesota - Clinical and Translational Science Institute

Additional 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
Study First Received: August 12, 2009
Last Updated: February 3, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013