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

Primary Purpose

Hyperglycemia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Resistant starch type 4 - raw

Resistant Starch Type 4 - Cooked

Dextrose

Puffed Wheat

About this trial

This is an interventional supportive care trial for Hyperglycemia focused on measuring Diabetes, Diet, Fiber, Age

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Kansas State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Resistant Starch Type 4-Raw

Resistant Starch Type 4-cooked

Puffed wheat

Dextrose

Outcomes

Primary Outcome Measures

Post-Prandial Metabolism

Secondary Outcome Measures

Full Information

NCT ID

NCT00687960

First Posted

May 22, 2008

Last Updated

May 28, 2008

Sponsor

Kansas State University

Collaborators

MGP Ingredients, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00687960

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

May 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Kansas State University

Collaborators

MGP Ingredients, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperglycemia

Keywords

Diabetes, Diet, Fiber, Age

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Resistant Starch Type 4-Raw

Arm Title

Arm Type

Experimental

Arm Description

Resistant Starch Type 4-cooked

Arm Title

Arm Type

Active Comparator

Arm Description

Puffed wheat

Arm Title

Arm Type

Placebo Comparator

Arm Description

Dextrose

Intervention Type

Dietary Supplement

Intervention Name(s)

Resistant starch type 4 - raw

Intervention Description

Dose: 80g bar containing Resistant Starch Type 4 - raw

Intervention Type

Dietary Supplement

Intervention Name(s)

Resistant Starch Type 4 - Cooked

Intervention Description

Dose: 80g bar containing Resistant Starch Type 4 - cooked

Intervention Type

Dietary Supplement

Intervention Name(s)

Dextrose

Intervention Description

Dose: 7 oz of oral glucose tolerance beverage

Intervention Type

Dietary Supplement

Intervention Name(s)

Puffed Wheat

Intervention Description

Dose: 80g bar containing puffed wheat cereal

Primary Outcome Measure Information:

Title

Post-Prandial Metabolism

Time Frame

Early morning

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Haub, Ph.D.

Organizational Affiliation

Department of Human Nutrition

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kansas State University

City

Manhattan

State/Province

Kansas

ZIP/Postal Code

66506

Country

United States

12. IPD Sharing Statement

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

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