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Satiety Response After Mixed Fiber Doses

This study has been completed.
Sponsor:
Collaborator:
Nestlé
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00889993
First received: April 27, 2009
Last updated: March 28, 2012
Last verified: March 2012

April 27, 2009
March 28, 2012
November 2007
October 2008   (final data collection date for primary outcome measure)
Satiety and Food Intake [ Time Frame: November 2007 thru May 2008 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00889993 on ClinicalTrials.gov Archive Site
Glucose, Insulin, Gut Hormone Response [ Time Frame: November 2007 thru October 2008 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Satiety Response After Mixed Fiber Doses
Effect of Four Doses of Mixed Fiber on Satiety, Food Intake, Glucose, Insulin, and Gut Hormone Release

People who eat more dietary fiber have a lower body weight than people who eat less fiber. Potential mechanisms include greater feelings of satiety, reductions in food intake, changes in blood glucose, insulin, or gut hormones.

The investigators hypothesize that increasing doses of mixed fiber will influence satiety response, food intake, glucose, insulin, ghrelin, GLP-1, and PYY 3-36, in a dose-dependent manner, when given to subjects in muffins for breakfast.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Satiety
Dietary Supplement: Mixed Fiber Supplement
Breakfast Muffin containing 0g, 4g, 8g, and 12g of mixed fiber (total fiber amount as listed).
Not Provided
Willis HJ, Thomas W, Eldridge AL, Harkness L, Green H, Slavin JL. Glucose and insulin do not decrease in a dose-dependent manner after increasing doses of mixed fibers that are consumed in muffins for breakfast. Nutr Res. 2011 Jan;31(1):42-7. doi: 10.1016/j.nutres.2010.12.006.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
October 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • English speaking
  • healthy men and women
  • 18 and 65 years of age
  • non-smoking
  • not taking medications
  • non-dieting (weight stable over last 3 months)
  • BMI between 18 and 27
  • able to give blood through an IV

Exclusion Criteria:

  • irregular or erratic breakfast eating patterns
  • food allergies to ingredients commonly found in muffins or pizza
  • distaste for muffins or pizza
  • BMI less than 18 or greater than 27
  • weight change > 5 kg in last 3 months (intentional or unintentional)
  • cardiovascular disease
  • diabetes mellitus (fasting blood sugar > 126 mg/dl)
  • cancer in prior 5 years (except basal cell carcinoma of skin)
  • renal or hepatic disease
  • Crohns disease
  • ulcerative colitis
  • any other gastrointestinal conditions that may affect digestion or absorption
  • recent bacterial infection (< 3 months)
  • chronic medication use
  • history of drug or alcohol abuse in prior 6 months
  • concurrent or recent intervention study participation
  • vegetarians
  • people who ate more than approximately 15 g of fiber per day
  • pregnant or lactating women
  • women with irregular menstrual cycles
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00889993
0701M00265
No
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Nestlé
Principal Investigator: Joanne L Slavin, PhD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
March 2012

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