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NCT00691249 Clinical Trial

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

Hyperglycemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00691249
Other study ID # KSU-HML-RSt3
Secondary ID
Status Completed
Phase N/A
First received May 22, 2008
Last updated June 30, 2009
Start date May 2008
Est. completion date June 2009

Study information
Verified date May 2008
Source Kansas State University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Type 2 Diabetics

Exclusion Criteria:

- Diagnosed with other metabolic disorders

- Allergies to wheat

- Non-smokers

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Resistant Starch Type 4-Raw
Low Dose- 70g bar
• Resistant Starch Type 4-Raw
High Dose- 100g bar
• Resistant Starch Type 4-Cooked
Low Dose- 70g bar
• Resistant Starch Type 4-Cooked
High dose: 100g bar
• Shredded Wheat
70g bar

Locations
Country Name City State
United States Kansas State Univerity: Department of Human Nutrition Manhattan Kansas

Sponsors (2)
Lead Sponsor Collaborator
Kansas State University MGP Ingredients, Inc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Post-Prandial metabolism Acute -- fasting, 15, 30, 45, 60, 90 and 120 minutes post-ingestion No
Secondary Satiety Early morning - Midafternoon No
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