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Effects of Dietary Fiber on Insulin Sensitivity

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ClinicalTrials.gov Identifier: NCT01521806
Recruitment Status : Unknown
Verified January 2012 by Ingredion Incorporated.
Recruitment status was:  Not yet recruiting
First Posted : January 31, 2012
Last Update Posted : January 31, 2012
Sponsor:
Information provided by (Responsible Party):
Ingredion Incorporated

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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE 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  ICMJE
  • 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  ICMJE 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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE 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