Effects of Dietary Fiber on Insulin Sensitivity

Tracking Information
First Submitted Date ICMJE	January 20, 2012
First Posted Date ICMJE	January 31, 2012
Last Update Posted Date	January 31, 2012
Study Start Date ICMJE	January 2012
Estimated Primary Completion Date	January 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 26, 2012)	Insulin sensitivity [ Time Frame: 5-hr test, performed 3 times within a 20-week period ]; A frequently sampled intravenous blood glucose tolerance test will be performed.
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: January 26, 2012)	Mitocondrial function [ Time Frame: 3 times, with a 20-week period ]A muscle biospy will be taken to assess mitochondrial function; Meal tolerance test [ Time Frame: 3 times, within a 20-week period ]A high-fat meal will be given and blood will be drawn over a three-hr period
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Effects of Dietary Fiber on Insulin Sensitivity
Official Title ICMJE	Effects of Dieatry Fiber on Insulin Sensitivity in Pre- and Post-menopausal Women
Brief Summary	This study will examine the effects of a dietary fiber on insulin sensitivity in overweight and obese women. The fiber will be added to snack foods and women will consume the foods for four weeks. In one four-week period, 15 g of fiber will be added, and 30 g will added in another period. In a third period, no fiber will be added to the snack foods. Insulin senstivity will be measured at the end of each treatment period.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition ICMJE	Focus of the Study is Insulin Sensitivity
Intervention ICMJE	Dietary Supplement: Dietary Fiber; Dietary fiber will be added to snack foods
Study Arms	Experimental: Low dose 15 g of fiber per day will be added to snack foods Intervention: Dietary Supplement: Dietary Fiber; Experimental: High dose 30 g of fiber per day will be added to snack foods Intervention: Dietary Supplement: Dietary Fiber; Placebo Comparator: No fiber Snack foods without fiber will be given Intervention: Dietary Supplement: Dietary Fiber
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: January 26, 2012)	40
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	September 2013
Estimated Primary Completion Date	January 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Impaired fasting glucose; Overweight and obese Exclusion Criteria: Diabetes, Presence of chronic diseases
Sex/Gender	Sexes Eligible for Study: Female
Ages	19 Years to 70 Years (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01521806
Other Study ID Numbers ICMJE	HM001
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Ingredion Incorporated
Study Sponsor ICMJE	Ingredion Incorporated
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Barbara Gower, PhD University of Alabama at Birmingham
PRS Account	Ingredion Incorporated
Verification Date	January 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP