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

NCT ID: NCT00691249

Last Updated: 2009-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-06-30

Brief Summary

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This study will test the effects of resistant starch type 4 on blood sugar and hunger in adults with Type 2 diabetes.

Detailed Description

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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.

Conditions

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Hyperglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Resistant starch type 4-Raw

Group Type EXPERIMENTAL

Resistant Starch Type 4-Raw

Intervention Type DIETARY_SUPPLEMENT

Low Dose- 70g bar

2

Resistant starch type 4-Raw

Group Type EXPERIMENTAL

Resistant Starch Type 4-Raw

Intervention Type DIETARY_SUPPLEMENT

High Dose- 100g bar

3

Resistant starch type 4-Cooked

Group Type EXPERIMENTAL

Resistant Starch Type 4-Cooked

Intervention Type DIETARY_SUPPLEMENT

Low Dose- 70g bar

4

Resistant starch type 4-Cooked

Group Type EXPERIMENTAL

Resistant Starch Type 4-Cooked

Intervention Type DIETARY_SUPPLEMENT

High dose: 100g bar

5

Shredded wheat

Group Type PLACEBO_COMPARATOR

Shredded Wheat

Intervention Type DIETARY_SUPPLEMENT

70g bar

Interventions

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Resistant Starch Type 4-Raw

Low Dose- 70g bar

Intervention Type DIETARY_SUPPLEMENT

Resistant Starch Type 4-Raw

High Dose- 100g bar

Intervention Type DIETARY_SUPPLEMENT

Resistant Starch Type 4-Cooked

Low Dose- 70g bar

Intervention Type DIETARY_SUPPLEMENT

Resistant Starch Type 4-Cooked

High dose: 100g bar

Intervention Type DIETARY_SUPPLEMENT

Shredded Wheat

70g bar

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Type 2 Diabetics

Exclusion Criteria

* Diagnosed with other metabolic disorders
* Allergies to wheat
* Non-smokers
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MGP Ingredients, Inc.

INDUSTRY

Sponsor Role collaborator

Kansas State University

OTHER

Sponsor Role lead

Responsible Party

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Department of Human Nutrition

Principal Investigators

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Mark Haub, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Human Nutrition

Locations

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Kansas State Univerity: Department of Human Nutrition

Manhattan, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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KSU-HML-RSt3

Identifier Type: -

Identifier Source: org_study_id

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