Comparison of Different Types of Resistant Starch

NCT ID: NCT00930956

Last Updated: 2010-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2009-05-31

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).

Conditions

Postprandial Hyperglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Dextrose

30 g of carbohydrate via Sun-Dex OGTT beverage

Group Type: ACTIVE_COMPARATOR

Resistant Starch

Intervention Type: DIETARY_SUPPLEMENT

30 g of carbohydrate per Arm

RS Type 2

30g Resistant Starch Type 2 (Hi-Maize 260, National Starch)

Group Type: EXPERIMENTAL

Resistant Starch

Intervention Type: DIETARY_SUPPLEMENT

30 g of carbohydrate per Arm

RS Type 4 (cross linked)

30g of cross linked RS type 4 (Fibersym RW, MGP Ingredients, Inc.)

Group Type: EXPERIMENTAL

Resistant Starch

Intervention Type: DIETARY_SUPPLEMENT

30 g of carbohydrate per Arm

Interventions

Resistant Starch

30 g of carbohydrate per Arm

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Hi-Maize 260; Fibersym RW

Eligibility Criteria

Inclusion Criteria

• apparently healthy

Exclusion Criteria

• diagnosis of any chronic disease
• wheat allergy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kansas State University

OTHER

Sponsor Role: lead

Responsible Party

Kansas State University

Principal Investigators

Mark D Haub, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kansas State University

Locations

Human Metabolism Laboratory (K-State Univ.)

Manhattan, Kansas, United States

Countries

United States

Other Identifiers

KSUHML09-RS

Identifier Type: -

Identifier Source: org_study_id