Effect of Resistant Starch Type 4 on Glycemia and Insulin... | NCT00687960

Studies
Effect of Resistant Starch Type 4 on Glycemia and Insulin Sensitivity in Young Adults

NCT00687960

Sponsor

Kansas State University

Status

Completed

Last Update Posted

Jun 2, 2008Estimated

Enrollment

13Actual

Phase

Not Applicable

Conditions

Hyperglycemia

Interventions

Resistant starch type 4 - raw
Resistant Starch Type 4 - Cooked
Dextrose
Puffed 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

Nov 2006

Primary Completion Date

May 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

May 22, 2008

First Submission Date that Met QC Criteria

May 28, 2008

First Posted Date

Jun 2, 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

May 28, 2008

Last Update Posted Date

Jun 2, 2008Estimated

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 tested the effects of resistant starch type 4 on blood sugar and hunger in young adults with Type 2 diabetes.

Detailed Description

To measure the blood glucose response, after an overnight fast, blood samples were collected before eating and at 15, 30, 45, 60, 90, and 120 minutes after each each bar. The incremental area under the curve was used to calculate the glycemic index and insulin sensitivity via minimal model.

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

13Actual

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-cooked	Dietary Supplement: Resistant Starch Type 4 - Cooked
3	Active Comparator	Puffed wheat	Dietary Supplement: Puffed Wheat
4	Placebo Comparator	Dextrose	Dietary Supplement: Dextrose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Resistant starch type 4 - raw	Dietary Supplement	Dose: 80g bar containing Resistant Starch Type 4 - raw	1

Measure	Description	Time Frame
Post-Prandial Metabolism		Early morning

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Apparently Healthy (not diagnosed with disease)
Young Adults (18-35)

Exclusion Criteria:

Diagnosed with diabetes or other metabolic disorders
Allergies to Wheat
Non-smokers

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

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 University		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

Intervention Browse Module

MeSH Terms

ID	Term
D005947	Glucose

Ancestor Terms

ID	Term
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided