Comparison of Different Types of Resistant Starch

July 28, 2010 updated by: Kansas State University

Resistant Starch Type 2 and Cross Linked Resistant Starch Type 4 on Blood Glucose

This study is to determine whether different types of resistant starch have different effects on blood glucose in healthy adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

11

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

  • United States
    • Kansas
      • Manhattan, Kansas, United States, 66502
        • Human Metabolism Laboratory (K-State Univ.)

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

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • apparently healthy

Exclusion Criteria:

  • diagnosis of any chronic disease
  • wheat allergy

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Dextrose
30 g of carbohydrate via Sun-Dex OGTT beverage
Dietary supplement: Resistant Starch
30 g of carbohydrate per Arm
Other Names:
  • Hi-Maize 260
  • Fibersym RW
EXPERIMENTAL: RS Type 2
30g Resistant Starch Type 2 (Hi-Maize 260, National Starch)
Dietary supplement: Resistant Starch
30 g of carbohydrate per Arm
Other Names:
  • Hi-Maize 260
  • Fibersym RW
EXPERIMENTAL: RS Type 4 (cross linked)
30g of cross linked RS type 4 (Fibersym RW, MGP Ingredients, Inc.)
Dietary supplement: Resistant Starch
30 g of carbohydrate per Arm
Other Names:
  • Hi-Maize 260
  • Fibersym RW

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood glucose
Time Frame: Acute response -- fasting and 30, 60, 90 and 120 minutes post-ingestion
Acute response -- fasting and 30, 60, 90 and 120 minutes post-ingestion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kansas State University

Investigators

  • Principal Investigator: Mark D Haub, Ph.D., Kansas State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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, 2006

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

June 30, 2009

First Submitted That Met QC Criteria

June 30, 2009

First Posted (ESTIMATE)

July 2, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 29, 2010

Last Update Submitted That Met QC Criteria

July 28, 2010

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSUHML09-RS

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.

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