Text Size

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
History of Changes
  Purpose

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.


Condition Intervention
Satiety
 Dietary Supplement: Mixed Fiber Supplement

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: Effect of Four Doses of Mixed Fiber on Satiety, Food Intake, Glucose, Insulin, and Gut Hormone Release

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 and Food Intake [ Time Frame: November 2007 thru May 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glucose, Insulin, Gut Hormone Response [ Time Frame: November 2007 thru October 2008 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: November 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Mixed Fiber Supplement
    Breakfast Muffin containing 0g, 4g, 8g, and 12g of mixed fiber (total fiber amount as listed).
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889993

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
Nestlé
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: NCT00889993     History of Changes
Other Study ID Numbers: 0701M00265
Study First Received: April 27, 2009
Last Updated: March 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Food intake
Gut hormones
Fiber
Visual analog scales

ClinicalTrials.gov processed this record on June 17, 2013