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

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.
ClinicalTrials.gov Identifier: NCT00691249
Recruitment Status : Completed
First Posted : June 5, 2008
Last Update Posted : July 2, 2009
Sponsor:
Collaborator:
MGP Ingredients, Inc.
Information provided by:
Kansas State University

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

Condition or disease Intervention/treatment Phase
Hyperglycemia Dietary Supplement: Resistant Starch Type 4-Raw Dietary Supplement: Resistant Starch Type 4-Cooked Dietary Supplement: Shredded Wheat Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Study Start Date : May 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

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
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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
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Principal Investigator: Mark Haub, Ph.D. Department of Human Nutrition

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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 Posted: June 5, 2008    Key Record Dates
Last Update Posted: July 2, 2009
Last Verified: May 2008

Keywords provided by Kansas State University:
Diabetes
Diet
Fiber

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