Resistant Starch on Glucose and Insulin Sensitivity in Individuals With Type 2 Diabetes
June 30, 2009 updated by: Kansas State University
This study will test the effects of resistant starch type 4 on blood sugar and hunger in adults with Type 2 diabetes.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
-
Manhattan, Kansas, United States, 66506
- Kansas State Univerity: Department of Human Nutrition
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Type 2 Diabetics
Exclusion Criteria:
- Diagnosed with other metabolic disorders
- Allergies to wheat
- Non-smokers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Resistant starch type 4-Raw
|
Low Dose- 70g bar
High Dose- 100g bar
|
|
Experimental: 2
Resistant starch type 4-Raw
|
Low Dose- 70g bar
High Dose- 100g bar
|
|
Experimental: 3
Resistant starch type 4-Cooked
|
Low Dose- 70g bar
High dose: 100g bar
|
|
Experimental: 4
Resistant starch type 4-Cooked
|
Low Dose- 70g bar
High dose: 100g bar
|
|
Placebo Comparator: 5
Shredded wheat
|
70g bar
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Post-Prandial metabolism
Time Frame: Acute -- fasting, 15, 30, 45, 60, 90 and 120 minutes post-ingestion
|
Acute -- fasting, 15, 30, 45, 60, 90 and 120 minutes post-ingestion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Satiety
Time Frame: Early morning - Midafternoon
|
Early morning - Midafternoon
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark Haub, Ph.D., Department of Human Nutrition
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
May 22, 2008
First Submitted That Met QC Criteria
June 4, 2008
First Posted (Estimate)
June 5, 2008
Study Record Updates
Last Update Posted (Estimate)
July 2, 2009
Last Update Submitted That Met QC Criteria
June 30, 2009
Last Verified
May 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSU-HML-RSt3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.