Satiety Response After Mixed Fiber Doses
Effect of Four Doses of Mixed Fiber on Satiety, Food Intake, Glucose, Insulin, and Gut Hormone Release
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 27, 2009
CompletedFirst Posted
Study publicly available on registry
April 29, 2009
CompletedMarch 29, 2012
March 1, 2012
11 months
April 27, 2009
March 28, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Satiety and Food Intake
November 2007 thru May 2008
Secondary Outcomes (1)
Glucose, Insulin, Gut Hormone Response
November 2007 thru October 2008
Interventions
Breakfast Muffin containing 0g, 4g, 8g, and 12g of mixed fiber (total fiber amount as listed).
Eligibility Criteria
You may qualify if:
- English speaking
- healthy men and women
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Minnesotalead
- Société des Produits Nestlé (SPN)collaborator
Study Sites (1)
University of Minnesota: General Clinical Research Center
Minneapolis, Minnesota, 55455, United States
Related Publications (1)
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.
PMID: 21310305DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Joanne L Slavin, PhD
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2009
First Posted
April 29, 2009
Study Start
November 1, 2007
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
March 29, 2012
Record last verified: 2012-03