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

This study has been completed.
Sponsor:
Collaborator:
MGP Ingredients, Inc
Information provided by:
Kansas State University
ClinicalTrials.gov Identifier:
NCT00691249
First received: May 22, 2008
Last updated: June 30, 2009
Last verified: May 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Satiety [ Time Frame: Early morning - Midafternoon ] [ Designated as safety issue: No ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Mark Haub Ph.D., Department of Human Nutrition
ClinicalTrials.gov Identifier: NCT00691249     History of Changes
Other Study ID Numbers: KSU-HML-RSt3
Study First Received: May 22, 2008
Last Updated: June 30, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Kansas State University:
Diabetes
Diet
Fiber

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Hyperglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 02, 2014