Comparison of Different Types of Resistant Starch

This study has been completed.
Sponsor:
Information provided by:
Kansas State University
ClinicalTrials.gov Identifier:
NCT00930956
First received: June 30, 2009
Last updated: July 28, 2010
Last verified: June 2009
  Purpose

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


Condition Intervention
Postprandial Hyperglycemia
Dietary Supplement: Resistant Starch

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Resistant Starch Type 2 and Cross Linked Resistant Starch Type 4 on Blood Glucose

Resource links provided by NLM:


Further study details as provided by Kansas State University:

Primary Outcome Measures:
  • Blood glucose [ Time Frame: Acute response -- fasting and 30, 60, 90 and 120 minutes post-ingestion ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: May 2006
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • apparently healthy

Exclusion Criteria:

  • diagnosis of any chronic disease
  • wheat allergy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00930956

Locations
United States, Kansas
Human Metabolism Laboratory (K-State Univ.)
Manhattan, Kansas, United States, 66502
Sponsors and Collaborators
Kansas State University
Investigators
Principal Investigator: Mark D Haub, Ph.D. Kansas State University
  More Information

Additional Information:
No publications provided

Responsible Party: Mark Haub, Kansas State University
ClinicalTrials.gov Identifier: NCT00930956     History of Changes
Other Study ID Numbers: KSUHML09-RS
Study First Received: June 30, 2009
Last Updated: July 28, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Kansas State University:
Diabetes
Obesity
Hyperglycemia
Dietary Fiber
Wheat
Grain

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014