Resistant Starch on Glucose and Insulin Sensitivity in Individuals With Type 2 Diabetes - Full Text View

Sponsors and Collaborators:	Kansas State University MGP Ingredients, Inc
Information provided by:	Kansas State University
ClinicalTrials.gov Identifier:	NCT00691249

Purpose

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

Condition	Intervention
Hyperglycemia	Dietary Supplement: Resistant Starch Type 4-Raw Dietary Supplement: Resistant Starch Type 4-Cooked Dietary Supplement: Shredded Wheat

MedlinePlus related topics: Diabetes Dietary Supplements

Drug Information available for: Insulin Starch Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Resistant Starch on Glucose and Insulin Sensitivity in Individuals With Type 2 Diabetes

Further study details as provided by Kansas State University:

Primary Outcome Measures:

Post-Prandial metabolism [ Time Frame: Early morning - Midafternoon ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Satiety [ Time Frame: Early morning - Midafternoon ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	May 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Resistant starch type 4-Raw	Dietary Supplement: Resistant Starch Type 4-Raw Low Dose- 70g bar
2: Experimental Resistant starch type 4-Raw	Dietary Supplement: Resistant Starch Type 4-Raw High Dose- 80g bar
3: Experimental Resistant starch type 4-Cooked	Dietary Supplement: Resistant Starch Type 4-Cooked Low Dose- 70g bar
4: Experimental Resistant starch type 4-Cooked	Dietary Supplement: Resistant Starch Type 4-Cooked High dose: 80g bar
5: Placebo Comparator Shredded wheat	Dietary Supplement: Shredded Wheat 70g bar

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. We 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 Diabetics

Exclusion Criteria:

Diagnosed with other metabolic disorders
Allergies to wheat
Non-smokers

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691249

Contacts

Contact: Mark Haub, Ph.D.

785-313-7430

haub@ksu.edu

Locations

United States, Kansas
Kansas State Univerity: Department of Human Nutrition	Recruiting
Manhattan, Kansas, United States, 66506
Principal Investigator: Mark Haub, Ph.D.

Sponsors and Collaborators

Kansas State University

MGP Ingredients, Inc

Investigators

Principal Investigator:

Mark Haub, Ph.D.

Department of Human Nutrition

More Information

Responsible Party:	Department of Human Nutrition ( Mark Haub Ph.D. )
Study ID Numbers:	KSU-HML-RSt3
Study First Received:	May 22, 2008
Last Updated:	June 4, 2008
ClinicalTrials.gov Identifier:	NCT00691249
Health Authority:	United States: Institutional Review Board

Keywords provided by Kansas State University:

Diabetes
Diet
Fiber

Study placed in the following topic categories:

Metabolic Diseases
Hyperglycemia
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

ClinicalTrials.gov processed this record on January 15, 2009