Effects of Resistant Starch in a Beverage on Post-prandial Glycemic and Insulinemic Responses

NCT ID: NCT02161250

Last Updated: 2014-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-06-30

Brief Summary

Hypothesis: A beverage with a resistant starch will blunt and sustain the post-prandial rise in blood glucose and insulin concentrations compared to beverage with maltodextrin (an easily digested carbohydrate).

Detailed Description

• About two-thirds of adults in the United States are overweight or obese which can cause adverse health consequences for those individuals. Post-prandial hyperglycemia is one of these possible consequences and is associated with a higher risk for Type 2 Diabetes. Controlling hyperglycemia is important in the prevention of the onset of diabetes and obesity. Resistant starch is a dietary carbohydrate which is not completely digested in the gut and produces energy for the body to use. The investigators are interested in assessing the effects of resistant starch on postprandial blood glucose and insulin concentrations.
• Aim: To assess the effects of a resistant starch on post-prandial blood glucose and insulin concentrations.
• Hypothesis: A beverage with a resistant starch will blunt and sustain the post-prandial rise in blood glucose and insulin concentrations compared to a beverage with maltodextrin (an easily digested carbohydrate).

Conditions

Hyperglycemia, Diabetes, and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Resistant starch

The test beverage consumed has the resistant starch.

Group Type: EXPERIMENTAL

Resistant Starch

Intervention Type: DIETARY_SUPPLEMENT

Each subject will complete 2 testing days (randomized and crossover design). On each of 2 test days, subjects will arrive at the Purdue Clinical Research Center after a 12-h fast and will consume a beverage containing resistant starch. The test beverage will be consumed along with a standard meal provided at the start of the test day. A second standard meal that does not contain the beverage will be consumed four hours later. Below is what will be included in the test bar.

Control

The control beverage uses maltodextrin rather than the resistant starch.

Group Type: EXPERIMENTAL

Control

Intervention Type: DIETARY_SUPPLEMENT

Each subject will complete 2 testing days (randomized and crossover design). On each of 2 test days, subjects will arrive at the Purdue Clinical Research Center after a 12-h fast and will consume a beverage containing maltodextrin. The test beverage will be consumed along with a standard meal provided at the start of the test day. A second standard meal that does not contain the beverage will be consumed four hours later. Below is what will be included in the test bar.

Interventions

Resistant Starch

Each subject will complete 2 testing days (randomized and crossover design). On each of 2 test days, subjects will arrive at the Purdue Clinical Research Center after a 12-h fast and will consume a beverage containing resistant starch. The test beverage will be consumed along with a standard meal provided at the start of the test day. A second standard meal that does not contain the beverage will be consumed four hours later. Below is what will be included in the test bar.

Intervention Type: DIETARY_SUPPLEMENT

Control

Each subject will complete 2 testing days (randomized and crossover design). On each of 2 test days, subjects will arrive at the Purdue Clinical Research Center after a 12-h fast and will consume a beverage containing maltodextrin. The test beverage will be consumed along with a standard meal provided at the start of the test day. A second standard meal that does not contain the beverage will be consumed four hours later. Below is what will be included in the test bar.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Thirty healthy men and women (aged 18-29y) will be recruited from the greater Lafayette, IN region with the expectation that ≥20 subjects will complete the study. Subjects must weigh >110 pounds, with a BMI between 20.0 and 29.9.

Exclusion Criteria

• Weight change > 3kg in the past 3 months
• Exercising vigorously over the past 3 months as well as no exercise 3 days prior to testing day
• Intestinal disorders including lipid mal-absorption or lactose intolerance
• Abnormal liver or kidney function tests; fasting blood glucose >100mg/dL
• Smoking
• Drinking more than 2 alcoholic drinks per day
• Taking lipid-lowering medications or dietary supplements affecting plasma cholesterol concentration.
• Subjects must not be pregnant or lactating.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ingredion Incorporated

INDUSTRY

Sponsor Role: collaborator

Purdue University

OTHER

Sponsor Role: lead

Responsible Party

Wayne Campbell

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wayne Campbell, Phd

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Locations

Purdue University

West Lafayette, Indiana, United States

Countries

United States

Other Identifiers

1312014354

Identifier Type: -

Identifier Source: org_study_id