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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00691249
First Posted: June 5, 2008
Last Update Posted: July 2, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
MGP Ingredients, Inc
Information provided by:
Kansas State University
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Resistant Starch on Glucose and Insulin Sensitivity in Individuals With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Kansas State University:

Primary Outcome Measures:
  • Post-Prandial metabolism [ Time Frame: Acute -- fasting, 15, 30, 45, 60, 90 and 120 minutes post-ingestion ]

Secondary Outcome Measures:
  • Satiety [ Time Frame: Early morning - Midafternoon ]

Enrollment: 10
Study Start Date: May 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Resistant starch type 4-Raw
Dietary Supplement: Resistant Starch Type 4-Raw
Low Dose- 70g bar
Experimental: 2
Resistant starch type 4-Raw
Dietary Supplement: Resistant Starch Type 4-Raw
High Dose- 100g bar
Experimental: 3
Resistant starch type 4-Cooked
Dietary Supplement: Resistant Starch Type 4-Cooked
Low Dose- 70g bar
Experimental: 4
Resistant starch type 4-Cooked
Dietary Supplement: Resistant Starch Type 4-Cooked
High dose: 100g bar
Placebo Comparator: 5
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. 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00691249


Locations
United States, Kansas
Kansas State Univerity: Department of Human Nutrition
Manhattan, Kansas, United States, 66506
Sponsors and Collaborators
Kansas State University
MGP Ingredients, Inc
Investigators
Principal Investigator: Mark Haub, Ph.D. Department of Human Nutrition
  More Information

Responsible Party: Mark Haub Ph.D., Department of Human Nutrition
ClinicalTrials.gov Identifier: NCT00691249     History of Changes
Other Study ID Numbers: KSU-HML-RSt3
First Submitted: May 22, 2008
First Posted: June 5, 2008
Last Update Posted: July 2, 2009
Last Verified: May 2008

Keywords provided by Kansas State University:
Diabetes
Diet
Fiber

Additional relevant MeSH terms:
Insulin Resistance
Hyperglycemia
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs