Comparison of Different Types of Resistant Starch

Postprandial Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930956
• Other study ID #: KSUHML09-RS
• Status: Completed
• Phase: N/A
• First received: June 30, 2009
• Last updated: July 28, 2010
• Start date: May 2006
• Est. completion date: May 2009

Study information

• Verified date: June 2009
• Source: Kansas State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• apparently healthy

Exclusion Criteria:

• diagnosis of any chronic disease

• wheat allergy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hyperglycemia
• Postprandial Hyperglycemia

Intervention

Dietary Supplement:
• Resistant Starch
30 g of carbohydrate per Arm

Locations

Country	Name	City	State
United States	Human Metabolism Laboratory (K-State Univ.)	Manhattan	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Kansas State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose		Acute response -- fasting and 30, 60, 90 and 120 minutes post-ingestion	No

External Links

•   Published manuscript of study