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Resistant Starch on Glycemic Response in Older Adults

Primary Purpose

Hyperglycemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistant Starch Type 4
Dextrose
Puffed wheat
Sponsored by
Kansas State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyperglycemia focused on measuring Aging, Diabetes, Diet, Fiber

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Apparently healthy (not diagnosed with disease)
  • Over 60 years of age

Exclusion Criteria:

  • Diagnosed with diabetes or other metabolic disorder
  • Allergies to wheat
  • Non-smokers

Sites / Locations

  • Human Metabolism Laboratory

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

Glycemic Response

Secondary Outcome Measures

Full Information

First Posted
May 8, 2008
Last Updated
May 22, 2008
Sponsor
Kansas State University
Collaborators
MGP Ingredients, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00676767
Brief Title
Resistant Starch on Glycemic Response in Older Adults
Official Title
Resistant Starch Type 4 on the Glycemic Response in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kansas State University
Collaborators
MGP Ingredients, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study was to determine how blood glucose changes after eating energy bars containing resistant starch type 4 compared with bars made with puffed wheat in healthy older adults.
Detailed Description
To measure the blood glucose response, we collected blood samples 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia
Keywords
Aging, Diabetes, Diet, Fiber

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Resistant Starch Type 4
Intervention Type
Dietary Supplement
Intervention Name(s)
Dextrose
Intervention Type
Dietary Supplement
Intervention Name(s)
Puffed wheat
Primary Outcome Measure Information:
Title
Glycemic Response
Time Frame
2-hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Apparently healthy (not diagnosed with disease) Over 60 years of age Exclusion Criteria: Diagnosed with diabetes or other metabolic disorder Allergies to wheat Non-smokers
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
City
Manhattan
State/Province
Kansas
ZIP/Postal Code
66506
Country
United States

12. IPD Sharing Statement

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Resistant Starch on Glycemic Response in Older Adults

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