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Effects of Dietary Fiber on Insulin Sensitivity

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by National Starch LLC.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
National Starch LLC
ClinicalTrials.gov Identifier:
NCT01521806
First received: January 20, 2012
Last updated: January 26, 2012
Last verified: January 2012
History of Changes
January 20, 2012
January 26, 2012
January 2012
January 2012   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Effects of Dietary Fiber on Insulin Sensitivity
Effects of Dieatry Fiber on Insulin Sensitivity in Pre- and Post-menopausal Women
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Focus of the Study is Insulin Sensitivity
Dietary Supplement: Dietary Fiber
Dietary fiber will be added to snack foods
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
September 2013
January 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Impaired fasting glucose
  • Overweight and obese

Exclusion Criteria:

  • Diabetes, Presence of chronic diseases
Sexes Eligible for Study: Female
19 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01521806
HM001
No
Not Provided
Not Provided
National Starch LLC
National Starch LLC
Not Provided
Principal Investigator: Barbara Gower, PhD University of Alabama at Birmingham
National Starch LLC
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP