Satiety, Glycemic, and Gastrointestinal Effects of Novel Fibers
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Jul 2008
Typical duration for not_applicable healthy
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
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 12, 2009
CompletedFirst Posted
Study publicly available on registry
August 13, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedFebruary 6, 2012
February 1, 2012
9 months
August 12, 2009
February 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Satiety
0, 15, 30, 45, 60, 90, 120, 180, 215 minutes postprandially
Secondary Outcomes (4)
ad libitum food intake
180 minutes postprandially and over 24 hours
Ghrelin, polypeptide YY (PYY), and glucagon-like peptide-1 (GLP-1) response
0, 30, 60 minutes postprandially
Gastrointestinal tolerance and fecal chemistry
following 7 days of treatment
Glucose/Insulin Response
0, 15, 30, 45, 60, 90, 120, 180 minutes postprandially
Study Arms (5)
No fiber
PLACEBO COMPARATORNo fiber added to study products
Resistant Starch
EXPERIMENTALMuffins, cereal, and bars made with a resistant starch
Resistant starch + soluble fiber
EXPERIMENTALMuffins, cereal, and bars made with a mixture of resistant starch and a soluble fiber
Fiber made from corn starch
EXPERIMENTALMuffins, cereal, and bars made with novel corn fiber
Fiber made from corn starch + soluble fiber
EXPERIMENTALMuffins, cereal, and bars made with a mixture of novel corn fiber and a soluble fiber
Interventions
Low fiber muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)
25 g resistant starch, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)
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)
25 g fiber made from corn starch, administered in a muffin, hot cereal and beverage (acute phase) or fiber bars and beverage (chronic phase)
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Minnesotalead
- Tate and Lyle Ingredients Francecollaborator
Study Sites (1)
University of Minnesota - General Clinical Research Center
Minneapolis, Minnesota, 55455, United States
Related Publications (1)
Timm DA, Thomas W, Boileau TW, Williamson-Hughes PS, Slavin JL. Polydextrose and soluble corn fiber increase five-day fecal wet weight in healthy men and women. J Nutr. 2013 Apr;143(4):473-8. doi: 10.3945/jn.112.170118. Epub 2013 Feb 20.
PMID: 23427334DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
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
August 12, 2009
First Posted
August 13, 2009
Study Start
July 1, 2008
Primary Completion
April 1, 2009
Study Completion
April 1, 2010
Last Updated
February 6, 2012
Record last verified: 2012-02