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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
May 22, 2008
June 5, 2008
July 2, 2009
May 2008
June 2009   (Final data collection date for primary outcome measure)
Post-Prandial metabolism [ Time Frame: Acute -- fasting, 15, 30, 45, 60, 90 and 120 minutes post-ingestion ]
Post-Prandial metabolism [ Time Frame: Early morning - Midafternoon ]
Complete list of historical versions of study NCT00691249 on ClinicalTrials.gov Archive Site
Satiety [ Time Frame: Early morning - Midafternoon ]
Same as current
Not Provided
Not Provided
 
Resistant Starch on Glucose and Insulin Sensitivity in Individuals With Type 2 Diabetes
Resistant Starch on Glucose and Insulin Sensitivity in Individuals With Type 2 Diabetes
This study will test the effects of resistant starch type 4 on blood sugar and hunger in adults with Type 2 diabetes.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Hyperglycemia
  • Dietary Supplement: Resistant Starch Type 4-Raw
    Low Dose- 70g bar
  • Dietary Supplement: Resistant Starch Type 4-Raw
    High Dose- 100g bar
  • Dietary Supplement: Resistant Starch Type 4-Cooked
    Low Dose- 70g bar
  • Dietary Supplement: Resistant Starch Type 4-Cooked
    High dose: 100g bar
  • Dietary Supplement: Shredded Wheat
    70g bar
  • Experimental: 1
    Resistant starch type 4-Raw
    Intervention: Dietary Supplement: Resistant Starch Type 4-Raw
  • Experimental: 2
    Resistant starch type 4-Raw
    Intervention: Dietary Supplement: Resistant Starch Type 4-Raw
  • Experimental: 3
    Resistant starch type 4-Cooked
    Intervention: Dietary Supplement: Resistant Starch Type 4-Cooked
  • Experimental: 4
    Resistant starch type 4-Cooked
    Intervention: Dietary Supplement: Resistant Starch Type 4-Cooked
  • Placebo Comparator: 5
    Shredded wheat
    Intervention: Dietary Supplement: Shredded Wheat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
June 2009
June 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 Diabetics

Exclusion Criteria:

  • Diagnosed with other metabolic disorders
  • Allergies to wheat
  • Non-smokers
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00691249
KSU-HML-RSt3
No
Not Provided
Not Provided
Mark Haub Ph.D., Department of Human Nutrition
Kansas State University
MGP Ingredients, Inc
Principal Investigator: Mark Haub, Ph.D. Department of Human Nutrition
Kansas State University
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP