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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
Kansas State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postprandial Hyperglycemia focused on measuring Diabetes, Obesity, Hyperglycemia, Dietary Fiber, Wheat, Grain

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

First Posted
June 30, 2009
Last Updated
July 28, 2010
Sponsor
Kansas State University
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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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