Resistant Starch on Glucose and Insulin Sensitivity in In... | NCT00691249

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

NCT00691249

Sponsor

Kansas State University

Status

Completed

Last Update Posted

Jul 2, 2009Estimated

Enrollment

10Actual

Phase

Not Applicable

Conditions

Hyperglycemia

Interventions

Resistant Starch Type 4-Raw
Resistant Starch Type 4-Raw
Resistant Starch Type 4-Cooked
Resistant Starch Type 4-Cooked
Shredded Wheat

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

May 22, 2008

First Submission Date that Met QC Criteria

Jun 4, 2008

First Posted Date

Jun 5, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2009

Last Update Posted Date

Jul 2, 2009Estimated

Name	Class
MGP Ingredients, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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. The investigators 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Resistant starch type 4-Raw	Dietary Supplement: Resistant Starch Type 4-Raw
2	Experimental	Resistant starch type 4-Raw	Dietary Supplement: Resistant Starch Type 4-Raw
3	Experimental	Resistant starch type 4-Cooked	Dietary Supplement: Resistant Starch Type 4-Cooked
4	Experimental	Resistant starch type 4-Cooked	Dietary Supplement: Resistant Starch Type 4-Cooked
5	Placebo Comparator	Shredded wheat	Dietary Supplement: Shredded Wheat

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Resistant Starch Type 4-Raw	Dietary Supplement	Low Dose- 70g bar	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-Prandial metabolism		Acute -- fasting, 15, 30, 45, 60, 90 and 120 minutes post-ingestion

Secondary Outcomes

Measure	Description	Time Frame
Satiety		Early morning - Midafternoon

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type 2 Diabetics

Exclusion Criteria:

Diagnosed with other metabolic disorders
Allergies to wheat
Non-smokers

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark Haub, Ph.D.	Department of Human Nutrition	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kansas State Univerity: Department of Human Nutrition		Manhattan	Kansas	66506	United States

Condition Browse Module

MeSH Terms

ID	Term
D006943	Hyperglycemia
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided