Comparison of Different Types of Resistant Starch
Primary Purpose
Postprandial Hyperglycemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistant Starch
Sponsored by
About this trial
This is an interventional prevention trial for Postprandial Hyperglycemia focused on measuring Diabetes, Obesity, Hyperglycemia, Dietary Fiber, Wheat, Grain
Eligibility Criteria
Inclusion Criteria:
- apparently healthy
Exclusion Criteria:
- diagnosis of any chronic disease
- wheat allergy
Sites / Locations
- Human Metabolism Laboratory (K-State Univ.)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Dextrose
RS Type 2
RS Type 4 (cross linked)
Arm Description
30 g of carbohydrate via Sun-Dex OGTT beverage
30g Resistant Starch Type 2 (Hi-Maize 260, National Starch)
30g of cross linked RS type 4 (Fibersym RW, MGP Ingredients, Inc.)
Outcomes
Primary Outcome Measures
Blood glucose
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00930956
Brief Title
Comparison of Different Types of Resistant Starch
Official Title
Resistant Starch Type 2 and Cross Linked Resistant Starch Type 4 on Blood Glucose
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kansas State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is to determine whether different types of resistant starch have different effects on blood glucose in healthy adults.
Detailed Description
Each volunteer will visit the laboratory in a 10-12 hour fasted state on three occasions over a three-week period, up to two visits/wk, with at least 48 hours between visits. Volunteers will be asked to refrain from vigorous physical activity and the consumption of alcohol the day before each testing visit. Randomization using a Latin Square design was applied to minimize confounding issues associated with the order of administration.
In the morning of each test, a finger-prick capillary blood samples will be collected to determine fasting (baseline) blood glucose levels. The volunteers will then consume the test solution assigned for that trial. Ten minutes will be allowed for the test solution to be consumed. Over the two hours following the start of each test, finger-prick capillary blood samples were collected at 30, 60, 90, and 120 min. Blood glucose levels will be immediately measured in duplicate using an automated blood glucose analyzer (YSI 2300, Yellow Springs, OH). Analysis of the collected sample was repeated if the difference between duplicate samples was greater than 0.1 mmol/L. Once the samples were analyzed, the data was entered and the incremental area under the curve was calculated using the trapezoidal model (GraphPad v5.0, La Jolla, CA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Hyperglycemia
Keywords
Diabetes, Obesity, Hyperglycemia, Dietary Fiber, Wheat, Grain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dextrose
Arm Type
Active Comparator
Arm Description
30 g of carbohydrate via Sun-Dex OGTT beverage
Arm Title
RS Type 2
Arm Type
Experimental
Arm Description
30g Resistant Starch Type 2 (Hi-Maize 260, National Starch)
Arm Title
RS Type 4 (cross linked)
Arm Type
Experimental
Arm Description
30g of cross linked RS type 4 (Fibersym RW, MGP Ingredients, Inc.)
Intervention Type
Dietary Supplement
Intervention Name(s)
Resistant Starch
Other Intervention Name(s)
Hi-Maize 260, Fibersym RW
Intervention Description
30 g of carbohydrate per Arm
Primary Outcome Measure Information:
Title
Blood glucose
Time Frame
Acute response -- fasting and 30, 60, 90 and 120 minutes post-ingestion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
apparently healthy
Exclusion Criteria:
diagnosis of any chronic disease
wheat allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark D Haub, Ph.D.
Organizational Affiliation
Kansas State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Human Metabolism Laboratory (K-State Univ.)
City
Manhattan
State/Province
Kansas
ZIP/Postal Code
66502
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.hindawi.com/journals/jnume/2010/230501.html
Description
Published manuscript of study
Learn more about this trial
Comparison of Different Types of Resistant Starch
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