Satiety Response After Mixed Fiber Doses

Satiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00889993
• Other study ID #: 0701M00265
• Status: Completed
• Phase: N/A
• First received: April 27, 2009
• Last updated: March 28, 2012
• Start date: November 2007
• Est. completion date: October 2008

Study information

• Verified date: March 2012
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Satiety

Intervention

Dietary Supplement:
• Mixed Fiber Supplement
Breakfast Muffin containing 0g, 4g, 8g, and 12g of mixed fiber (total fiber amount as listed).

Locations

Country	Name	City	State
United States	University of Minnesota: General Clinical Research Center	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satiety and Food Intake		November 2007 thru May 2008	No
Secondary	Glucose, Insulin, Gut Hormone Response		November 2007 thru October 2008	No