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Effect of Resistant Starch Type 4 on Glycemia and Insulin Sensitivity in Young Adults

This study has been completed.
Sponsor:
Collaborator:
MGP Ingredients, Inc
Information provided by:
Kansas State University
ClinicalTrials.gov Identifier:
NCT00687960
First received: May 22, 2008
Last updated: May 28, 2008
Last verified: May 2008
History of Changes
  Purpose

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


Condition Intervention
Hyperglycemia
 Dietary Supplement: Resistant starch type 4 - raw
Dietary Supplement: Resistant Starch Type 4 - Cooked
Dietary Supplement: Dextrose
Dietary Supplement: Puffed 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: Effect of Resistant Starch Type 4 on Glycemia and Insulin Sensitivity in Young Adults

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Kansas State University:

Primary Outcome Measures:
  • Post-Prandial Metabolism [ Time Frame: Early morning ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: November 2006
Study Completion Date: December 2007
Primary Completion Date: May 2007 (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
Dose: 80g bar containing Resistant Starch Type 4 - raw
Experimental: 2
Resistant Starch Type 4-cooked
 Dietary Supplement: Resistant Starch Type 4 - Cooked
Dose: 80g bar containing Resistant Starch Type 4 - cooked
Active Comparator: 3
Puffed wheat
 Dietary Supplement: Puffed Wheat
Dose: 80g bar containing puffed wheat cereal
Placebo Comparator: 4
Dextrose
 Dietary Supplement: Dextrose
Dose: 7 oz of oral glucose tolerance beverage

Detailed Description:

To measure the blood glucose response, after an overnight fast, blood samples were collected before eating and at 15, 30, 45, 60, 90, and 120 minutes after each each bar. The incremental area under the curve was used to calculate the glycemic index and insulin sensitivity via minimal model.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Apparently Healthy (not diagnosed with disease)
  • Young Adults (18-35)

Exclusion Criteria:

  • Diagnosed with diabetes or other metabolic disorders
  • Allergies to Wheat
  • Non-smokers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00687960

Locations
United States, Kansas
Kansas State University
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: NCT00687960     History of Changes
Other Study ID Numbers: KSU-HML-RSt2
Study First Received: May 22, 2008
Last Updated: May 28, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Kansas State University:
Diabetes
Diet
Fiber
Age

Additional relevant MeSH terms:
Hyperglycemia
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hyperinsulinism

ClinicalTrials.gov processed this record on May 21, 2013