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

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

Shredded Wheat

About this trial

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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Type 2 Diabetics

Exclusion Criteria:

Diagnosed with other metabolic disorders
Allergies to wheat
Non-smokers

Sites / Locations

Kansas State Univerity: Department of Human Nutrition

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Resistant starch type 4-Raw

Resistant starch type 4-Cooked

Shredded wheat

Outcomes

Primary Outcome Measures

Post-Prandial metabolism

Secondary Outcome Measures

Satiety

Full Information

NCT ID

NCT00691249

First Posted

May 22, 2008

Last Updated

June 30, 2009

Sponsor

Kansas State University

Collaborators

MGP Ingredients, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00691249

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Completed

Study Start Date

May 2008 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (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 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.

6. Conditions and Keywords

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

Hyperglycemia

Keywords

Diabetes, Diet, Fiber

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

10 (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-Raw

Arm Title

Arm Type

Experimental

Arm Description

Resistant starch type 4-Cooked

Arm Title

Arm Type

Experimental

Arm Description

Resistant starch type 4-Cooked

Arm Title

Arm Type

Placebo Comparator

Arm Description

Shredded wheat

Intervention Type

Dietary Supplement

Intervention Name(s)

Resistant Starch Type 4-Raw

Intervention Description

Low Dose- 70g bar

Intervention Type

Dietary Supplement

Intervention Name(s)

Resistant Starch Type 4-Raw

Intervention Description

High Dose- 100g bar

Intervention Type

Dietary Supplement

Intervention Name(s)

Resistant Starch Type 4-Cooked

Intervention Description

Low Dose- 70g bar

Intervention Type

Dietary Supplement

Intervention Name(s)

Resistant Starch Type 4-Cooked

Intervention Description

High dose: 100g bar

Intervention Type

Dietary Supplement

Intervention Name(s)

Shredded Wheat

Intervention Description

70g bar

Primary Outcome Measure Information:

Title

Post-Prandial metabolism

Time Frame

Acute -- fasting, 15, 30, 45, 60, 90 and 120 minutes post-ingestion

Secondary Outcome Measure Information:

Title

Satiety

Time Frame

Early morning - Midafternoon

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Type 2 Diabetics Exclusion Criteria: Diagnosed with 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 Univerity: Department of Human Nutrition

City

Manhattan

State/Province

Kansas

ZIP/Postal Code

66506

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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