Effects of Dietary Fiber on Insulin Sensitivity

The recruitment status of this study is unknown because the information has not been verified recently.

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

Tracking Information

First Received Date ^ICMJE

January 20, 2012

Last Updated Date

January 26, 2012

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 ] [ Designated as safety issue: No ]

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

Mitocondrial function [ Time Frame: 3 times, with a 20-week period ] [ Designated as safety issue: No ]
A muscle biospy will be taken to assess mitochondrial function
Meal tolerance test [ Time Frame: 3 times, within a 20-week period ] [ Designated as safety issue: No ]
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 Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 Arm (s)

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

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated 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

Gender

Female

Ages

19 Years to 70 Years (Adult, Senior)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Brandon Kane

205-975-9629

kane003@uab.edu

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

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

National Starch LLC

Study Sponsor ^ICMJE

National Starch LLC

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Barbara Gower, PhD

University of Alabama at Birmingham

Information Provided By

National Starch LLC

Verification Date

January 2012

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

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