Resistant Starch on Glucose and Insulin Sensitivity in Individuals With Type 2 Diabetes - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 22, 2008

Last Updated Date

June 4, 2008

Start Date ^†

May 2008

Current Primary Outcome Measures ^†

Post-Prandial metabolism [ Time Frame: Early morning - Midafternoon ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00691249 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Satiety [ Time Frame: Early morning - Midafternoon ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Resistant Starch on Glucose and Insulin Sensitivity in Individuals With Type 2 Diabetes

Official Title ^†

Resistant Starch on Glucose and Insulin Sensitivity in Individuals With Type 2 Diabetes

Brief Summary

This study will test the effects of resistant starch type 4 on blood sugar and hunger in adults with Type 2 diabetes.

Detailed Description

To measure the blood glucose response, after an overnight fast, blood samples will be collected before eating and 15, 30, 45, 60, 90, and 120 minutes after eating each bar. The incremental area under the curve was used to calculate glycemic index. We will also measure the second meal effect by measuring the metabolic response (glucose, insulin, and gut hormones) after a standardized lunch two hours following the first assessment.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Supportive Care, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study

Condition ^†

Hyperglycemia

Intervention ^†

Dietary Supplement: Resistant Starch Type 4-Raw
Dietary Supplement: Resistant Starch Type 4-Cooked
Dietary Supplement: Shredded Wheat

Study Arms / Comparison Groups

Experimental: Resistant starch type 4-Raw
Experimental: Resistant starch type 4-Cooked
Placebo Comparator: Shredded wheat

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

Estimated Completion Date

February 2009

Estimated Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Type 2 Diabetics

Exclusion Criteria:

Diagnosed with other metabolic disorders
Allergies to wheat
Non-smokers

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^††

Contact: Mark Haub, Ph.D.

785-313-7430

haub@ksu.edu

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00691249

Responsible Party

Mark Haub Ph.D., Department of Human Nutrition

Secondary IDs ^††

Study Sponsor ^†

Kansas State University

Collaborators ^††

MGP Ingredients, Inc

Investigators ^†

Principal Investigator:

Mark Haub, Ph.D.

Department of Human Nutrition

Information Provided By

Kansas State University

Verification Date

May 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.