Resistant Starch on Glycemic Response in Older Adults | NCT00676767

Studies
Resistant Starch on Glycemic Response in Older Adults

NCT00676767

Sponsor

Kansas State University

Status

Completed

Last Update Posted

May 23, 2008Estimated

Enrollment

9Actual

Phase

Not Applicable

Conditions

Hyperglycemia

Interventions

Resistant Starch Type 4
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

Aug 2006

Primary Completion Date

Nov 2006Actual

Completion Date

Nov 2006Actual

First Submitted Date

May 8, 2008

First Submission Date that Met QC Criteria

May 12, 2008

First Posted Date

May 13, 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 22, 2008

Last Update Posted Date

May 23, 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

The purpose of this study was to determine how blood glucose changes after eating energy bars containing resistant starch type 4 compared with bars made with puffed wheat in healthy older adults.

Detailed Description

To measure the blood glucose response, we collected blood samples 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.

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

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Experimental	Dietary Supplement: Resistant Starch Type 4
2	Active Comparator	Dietary Supplement: Dextrose
3	Placebo Comparator	Dietary Supplement: Puffed wheat

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Resistant Starch Type 4	Dietary Supplement		1
Dextrose

Measure	Description	Time Frame
Glycemic Response		2-hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Apparently healthy (not diagnosed with disease)
Over 60 years of age

Exclusion Criteria:

Diagnosed with diabetes or other metabolic disorder
Allergies to wheat
Non-smokers

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mark D Haub, Ph.D	Kansas State University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Human Metabolism Laboratory		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