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
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Sponsor:
Ingredion Incorporated
Information provided by (Responsible Party):
Ingredion Incorporated
Tracking Information | ||||
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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 |
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.
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE |
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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 |
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Condition ICMJE | Focus of the Study is Insulin Sensitivity | |||
Intervention ICMJE | Dietary Supplement: Dietary Fiber
Dietary fiber will be added to snack foods |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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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 |